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Early intervention to protect the mother-infant relationship following postnatal depression: study protocol for a randomised controlled trial



At least 13% of mothers experience depression in the first postnatal year, with accompanying feelings of despair and a range of debilitating symptoms. Serious sequelae include disturbances in the mother-infant relationship and poor long-term cognitive and behavioural outcomes for the child. Surprisingly, treatment of maternal symptoms of postnatal depression does not improve the mother-infant relationship for a majority of women. Targeted interventions to improve the mother-infant relationship following postnatal depression are scarce and, of those that exist, the majority are not evaluated in randomised controlled trials. This study aims to evaluate a brief targeted mother-infant intervention, to follow cognitive behavioural therapy treatment of postnatal depression, which has the potential to improve developmental outcomes of children of depressed mothers.


The proposed study is a two-arm randomised controlled trial with follow-up to 6 months. One hundred participants will be recruited via referrals from health professionals including maternal and child health nurses and general practitioners, as well as self-referrals from women who have seen promotional materials for the study. Women who meet inclusion criteria (infant aged <12 months, women 18+ years of age) will complete the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-IV-TR Axis I Disorders. Those with a clinical diagnosis of current major or minor depressive disorder and who do not meet exclusion criteria (that is, currently receiving treatment for depression, significant difficulty with English, medium to high suicide risk, current self-harm, current substance abuse, current post-traumatic stress disorder, current manic/hypomanic episode or psychotic symptoms) will be randomised to receive either a 4-session mother-infant intervention (HUGS: Happiness Understanding Giving and Sharing) or a 4-session attention placebo playgroup (Playtime) following a 12-session postnatal depression group treatment programme. Primary outcome measures are the Parenting Stress Index (self-report measure) and the Parent-child Early Relational Assessment (observational measure coded by a blinded observer). Measurements are taken at baseline, after the postnatal depression programme, post-HUGS/Playtime, and at 6 months post-HUGS/Playtime.


This research addresses the need for specific treatment for mother-infant interactional difficulties following postnatal depression. There is a need to investigate interventions in randomised trials to prevent detrimental effects on child development and make available evidence-based treatments.

Trial registration

Australia and New Zealand Clinical Trials Register: ACTRN12612001110875. Date Registered: 17 October 2012.

Peer Review reports


Around 7.1% of new mothers have a major depressive episode during the first 3 months after delivery with an additional 12.1% of women suffering minor depression[1]. Postnatal depression (PND) is accompanied by a range of disturbing symptoms which can have a profound effect on the mother. Symptoms can include depressed mood, loss of interest, weight loss or gain, sleep disturbance, lack of energy, feeling agitated or slowed down, feelings of worthlessness or guilt, loss of concentration, and thoughts of death or suicide[2]. High anxiety is often co-morbid[3]. Symptoms of PND take on a particular significance due to the presence of an infant.

Interactional difficulties accompanying postnatal depression

Current research strongly suggests that PND interferes with the behavioural and emotional exchanges between mother and infant[4]. Depressed mothers gaze less at their infants, rock their infants less, are less active and decisive, have less well-timed responsiveness, demonstrate lower levels of warm acceptance, are emotionally flat, and often disengaged[58]. Our earlier work demonstrated that infant development is powerfully shaped by the quality of the early mother-infant interaction following PND[9, 10]. These interactions are complicated, involving reciprocal, inter-dependent effects between child and mother. Brazelton and colleagues[11], Tronick and Weinberg[12], and Stern[13] describe the critical elements of a successful interaction, which includes an emotionally attuned and responsive mother. Emotional unavailability following depression may result in an escalating cycle of dysfunctional behaviours in both mother and child (for instance, maternal flat affect leading to gaze aversion in the infant leading to feelings of rejection in the mother and withdrawal).

Importance of early mother-infant relationships

There is a growing awareness of the importance of early experiences in shaping infant brain development. Due to the plasticity of the brain at this early developmental stage, stressful experiences, including interactions with an un-attuned caregiver, may evoke permanent changes in brain organization[1416]. The National Forum on Early Childhood Program Evaluation[17] concluded that infants of women with PND may experience “lasting effects on their brain architecture and persistent disruptions of their stress response systems” (page 3). Cognitive, emotional and social capabilities are all inextricably linked in brain development[18]. During the first 3 years of life, brain development is at its fastest and the brain is at its most malleable phase and most vulnerable to disrupted care-giving relationships. Intervening early is therefore imperative.

Consequences of poor mother-infant interactions

Both short- and longer-term consequences have been reported for children of depressed and non-depressed mothers[1922]. These can include poor social and cognitive outcomes from infancy to school age[6, 2328], including poor psychological adaptation in adolescence[29], poor early school performance[30, 31], later anxiety[32], poorer self-regulatory capacities[33] and attachment insecurity[34] which in turn negatively affects subsequent interpersonal relationships[35], and has been linked with later behavioural problems[36]. As early as 3 months of age, infants of depressed mothers appear to generalise their depressed style of interaction to non-depressed adults[37].

Current evidence suggests that the mother-infant relationship is an important mediator between depression trajectories and child developmental outcomes (for example,[38]). In previous studies we demonstrated the critical importance of behavioural synchrony in the mother-infant interaction in the formation of attachment between mothers and their babies[39, 40]. More recently, we found that the quality (maternal responsiveness) of the early mother-infant relationship mediated poor child cognitive and behavioural outcomes at 4 years of age in a sample of women with PND[9]. Other evidence suggests ongoing difficulties to adolescence, particularly if depression is chronic[41, 42, 22].

Treating mother-infant difficulties following postnatal depression

There is a critical need for brief interventions addressing mother-infant difficulties following PND, as treating maternal mood alone is not sufficient for improving mother-infant relationship difficulties[43]. A review of existing mother-infant interventions targeted at women with PND revealed that current studies of interventions were scarce, rarely used randomised controlled trial (RCT) methodology, are poorly evaluated, of long duration, and generally have not assessed infant outcomes[4456]. In addition, many are not integrated with PND treatment of maternal mood symptoms. A brief mother-infant intervention that can change the developmental trajectory of infants of mothers with PND is of major public health significance and will potentially have important implications for preventing later emotional and behavioural disturbances in infants. In addition, this is most likely to improve outcomes if maternal depression is treated in order to facilitate the mother’s capacity to be emotionally available to her infant[7, 57]. This study aims to address the deficits in previous research: we use RCT methodology, an adequate sample size, an easily deliverable mother-infant intervention for mothers with PND that has been pilot tested, and assessment of both maternal and infant outcomes.


Aims and objective

In a RCT, this study aims to evaluate the effectiveness of a targeted intervention (HUGS; Happiness, Understanding, Giving and Sharing) for enhancing mother-infant relationships.

The primary aim of the study is to determine whether women undergoing the combined PND treatment and HUGS programme will show greater improvement compared to a control group who received the PND treatment followed by an attention placebo playgroup (Playtime) in: 1) the observed quality of the mother-infant interaction; and 2) maternal reports of parenting stress, including feelings of attachment to their infant.

The secondary aim of the study is to determine whether infants undergoing the HUGS programme will show greater improvement compared to infants in the control condition in terms of: 1) difficult infant behaviour; and 2) early developmental milestones.

In addition, improvements in maternal mood are expected following the PND treatment and maternal mood is expected to continue to improve with the HUGS programme.


The proposed research is a multi-site, parallel, two-group RCT involving 100 participants (n = 50 in each condition) and will be conducted in line with CONSORT standards ([58, 59]; Figure 1 shows the design of the study.

Figure 1

Study flow diagram. HUGS, Happiness Understanding Giving and Sharing; PND, postnatal depression.


Ethical approval has been obtained from Austin Health Human Research Ethics Committee (Project No. H2012/04745). Recruitment will be via referrals from health professionals including maternal and child health nurses and general practitioners, as well as self-referrals from women who have seen promotional materials for the study. They will be offered information sheets and consent forms where appropriate. After receiving informed consent, women will be screened with either the Edinburgh Postnatal Depression Scale[60] or the Whooley questions[61].

Women with a positive screening result (Edinburgh Postnatal Depression Scale ≥13 or an affirmative response to at least one of the two Whooley questions) will be assessed using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-IV-TR Axis I Disorders[62] to yield a diagnosis of current major or minor depressive disorder. Baseline questionnaires will be completed. Women who meet eligibility criteria will be randomly allocated to receive either HUGS or the attention placebo (Playtime) following the PND programme.


Women are randomised prior to commencing the 9-week PND programme. A coded, double-blinded, variable-length permuted blocks randomised treatment allocation schedule produced by computer algorithm will be used. The allocation schedule will be stratified by site. It is not feasible to conceal the content of the intervention from those delivering the treatment. Participants will be blind to which condition is the intervention as both conditions will be presented as potentially beneficial.

Inclusion and exclusion criteria

Inclusion criteria

Women with a clinical diagnosis of current major or minor depressive disorder as measured by the structured clinical interview, 18 years of age or older, and with an infant aged <12 months of age will be included in this study.

Exclusion criteria

Women fulfilling one or more of the following criteria will be excluded from participating in this study: currently receiving treatment for depression, significant difficulty with English, medium to high suicide risk, current self-harm, current substance abuse, current post-traumatic stress disorder, current manic/hypomanic episode or psychotic symptoms.

Study outcome measures

The measures and time points of administration are shown in Table 1. The primary outcome measures are the Parenting Stress Index (PSI) and the Parent-child Early Relational Assessment (PCERA). All instruments to be used are established, well-validated, reliable and widely used, with well-described psychometric properties.

Table 1 Summary and timing of measures



Participants allocated to the HUGS treatment will receive the previously evaluated 9-week manualised PND group programme followed by four sessions of mother-infant HUGS group treatment as described by Milgrom and colleagues[71, 72]. The 9-week PND programme consists of nine cognitive behavioural therapy sessions and three evening couple sessions (12 sessions in total). The PND programme addresses maternal mood, behavioural activation, cognitive strategies, self-esteem, adaptation of relaxation training to focus on ways to “relax on the run”, the couple relationship, getting support, practical issues, problem-solving and self-care from a cognitive behavioural therapy framework. The HUGS sessions include psychoeducation and direct intervention in the mother-infant interaction. This builds on skills developed in the PND treatment programme, allowing a short duration “booster” to change the negative trajectory of mother-infant interactions. It has been successfully trialled in a feasibility study[10]. HUGS sessions include:

Session 1 Play and physical contact: play provides interactional opportunities. It allows assessment of interactional deficits and modelling of alternative responses.

Session 2 Observing and understanding baby’s signals: essential elements of a ‘good enough’ interaction are taught to parents using guided exercises to maximise small successes.

Session 3 Parental responses to infant cues: building on cognitive strategies learnt, distorted cognitions are challenged including separating past experiences from the reality of the infant. Infants can re-awaken powerful memories of earlier family relationships[73].

Session 4 Consolidating gains: reinforcing positive interactional behaviours and cognitions about the infant (booster session).

Control group

Participants allocated to the control group will receive the PND programme (described above). This is followed by four non-directive group meetings of mothers, infants and a facilitator in the same surroundings as HUGS but with no direct therapeutic work (acting as an attention placebo). This controls for possible effects of group membership, social networking and therapist contact. The “Playtime” playgroup has been developed to be consistent with what is currently provided in community playgroups and which mothers generally find supportive and includes four sessions providing an opportunity for informal discussion between mothers, some psychoeducation (for example, healthy eating) as well as time to play with babies.

Data analysis

Power calculations

The primary outcomes are post-treatment/follow-up scores on mother-infant relationship measures: the PSI and PCERA. Based on published parameter estimates on the PSI (baseline = 282.46, σ = 41.25) from Milgrom and colleagues[10], a between-group difference of (δ) 33 points would take scores into the normative range on the PSI (that is, ≤250). To detect a change of 33 points, the sample size per condition is n = 15.7 (14.25/33)2 = 24.53. For the PCERA we wish to detect a medium to large effect size (2/3 SD). This is within the range of effect sizes reported for a longer mother-infant intervention measured with the PCERA[45, 46]. This yields n = 15.7 (1/.66)2 = 36.04, which rounds to 40. Taking the highest estimate (PCERA) and allowing 10% attrition, the adjusted group is n* = n/(1-.10)2 = 49.38, which rounds to 50 depressed women in each condition.


Data will be screened to: (i) check for data entry errors; and (ii) test the assumptions underlying parametric procedures. For each outcome, a priori treatment comparisons will be conducted by fitting models controlling for baseline values, to yield direct comparisons of the effectiveness of the two conditions. Intention-to-treat principles following CONSORT guidelines will prevent systematic bias[59]. Baseline data will be secured prior to allocation, and missing values will be scrutinized to check for non-random distribution and imputed at the case level using gold-standard maximum likelihood methods (Multiple Imputation). Primary analyses will be executed twice: once using observed data, and once using multiple imputation methods given by Schafer[74], so that all 100 participants will be analysed in their allocated treatment condition. To assess how non-compliance affects results, the dose-response relationship between session attendance and level of clinical improvement will be explored. Primary data analyses will be conducted fully blind to treatment allocation (via coded treatment labels).


PND is prevalent and there is accumulating evidence that PND results in early dysfunctional relationships between mothers and infants with long-term consequences on infant brain development, cognitive functioning, emotional health and behaviour. For these reasons, there is a critical need for interventions addressing mother-infant difficulties following PND to explore whether later difficulties can be prevented. Mother-infant difficulties need to be addressed as soon as possible to prevent cumulative detrimental effects on child development[9, 10]. The HUGS intervention is innovative both in its brevity and conceptualisation. The vast majority of existing mother-infant interventions are intensive and/or long term. A brief, four-session intervention would be cost effective and could be rolled out to large numbers. Given the high prevalence of PND and that 70% of women with PND have relationship difficulties with their infants[9], a highly novel contribution of this study is the development of a brief, effective intervention that is easily taken up by primary care providers and added to existing treatment for PND.

Given the world-wide advocacy for universal screening for depression perinatally[75], there will be a sharp increase in the number of women identified and managed for their depressive condition. Best-practice pathways for women identified as being depressed perinatally need to be developed. A brief mother-infant intervention that can be added onto an existing treatment for PND would be an innovative way to provide a care pathway. In light of this, we developed the HUGS programme, a cost-effective, early intervention to bolster and protect the mother-infant relationship and prevent the intergenerational transmission of risk. The significance of early childhood experiences on adult health later in life is evident and, as such, the social and economic benefits of such an intervention are substantial.

Trial status

At the time of manuscript submission, participant recruitment had not been completed. The trial is ongoing.



Happiness Understanding Giving and Sharing


Parent-child Early Relational Assessment


postnatal depression


Parenting Stress Index


randomised controlled trial.


  1. 1.

    Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T: Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005, 106: 1071-1083. 10.1097/01.AOG.0000183597.31630.db.

    Article  PubMed  Google Scholar 

  2. 2.

    Bonari L, Pinto N, Ahn E, Einarson A, Steiner M, Koren G: Perinatal risks of untreated depression during pregnancy. Can J Psychiatry. 2004, 49: 726-735.

    PubMed  Google Scholar 

  3. 3.

    Ross LE, McLean LM: Anxiety disorders during pregnancy and the postpartum period: a systematic review. J Clin Psychiatry. 2006, 67: 1285-1298. 10.4088/JCP.v67n0818.

    Article  PubMed  Google Scholar 

  4. 4.

    Diego MA, Field T, Jones NA, Hernandez-Reif M: Withdrawn and intrusive maternal interaction style and infant frontal EEG asymmetry shifts in infants of depressed and non-depressed mothers. Infant Behav Dev. 2006, 29: 220-229. 10.1016/j.infbeh.2005.12.002.

    Article  PubMed  PubMed Central  Google Scholar 

  5. 5.

    Field TM: The treatment of depressed mothers and infants. Postpartum Depression & Child Development. Edited by: Murray L, Cooper PJ. 1997, New York: Guilford, 221-236.

    Google Scholar 

  6. 6.

    Murray L, Fiori-Cowley A, Hooper R, Cooper P: The impact of postnatal depression and associated adversity on early mother infant interaction and later infant outcome. Child Dev. 1996, 67: 2512-2516. 10.2307/1131637.

    CAS  Article  PubMed  Google Scholar 

  7. 7.

    Murray L, Cooper PJ, Wilson A, Romaniuk H: Controlled trial of effect of treatment of postpartum depression. 2. Impact on the mother-child relationship and child outcome. British J of Psychiatry. 2003, 182: 420-427. 10.1192/bjp.182.5.420.

    Article  Google Scholar 

  8. 8.

    Reck C, Hunt A, Fuchs T, Weiss R, Noon A, Moehler E, Mundt C: Interactive regulation of affect in postpartum depressed mothers and their infants: an overview. Psychopathology. 2004, 37: 272-280. 10.1159/000081983.

    Article  PubMed  Google Scholar 

  9. 9.

    Milgrom J, Westley DT, Gemmill AW: The mediating role of maternal responsiveness in some longer term effects of postnatal depression on infant development. Infant Behav Dev. 2004, 27: 443-454. 10.1016/j.infbeh.2004.03.003.

    Article  Google Scholar 

  10. 10.

    Milgrom J, Ericksen J, McCarthy RM, Gemmill AW: Stressful impact of depression on early mother-infant relations. Stress Health. 2006, 22: 229-238. 10.1002/smi.1101.

    Article  Google Scholar 

  11. 11.

    Brazelton TB, Koslowski B, Main M: The early mother-infant interaction. The Effect Of The Infant On Its Caregiver. Edited by: Lewis M, Rosenblum LA. 1974, Oxford, England: Wiley-Interscience, 49-76.

    Google Scholar 

  12. 12.

    Tronick EZ, Weinberg MK: Depressed mothers and infants: failure to form dyadic states of consciousness. Postpartum Depression and Child Development. Edited by: Murray L, Cooper PJ. 1997, New York: Guildford Press, 54-81.

    Google Scholar 

  13. 13.

    Stern DN: The Interpersonal World of the Infant. 1985, New York: Basic Books

    Google Scholar 

  14. 14.

    Cirulli F, Berry A, Alleva E: Early disruption of mother-infant relationship: effects on brain plasticity and implications for psychopathology. Neurosc and Biobehal Rev. 2003, 27: 73-82. 10.1016/S0149-7634(03)00010-1.

    CAS  Article  Google Scholar 

  15. 15.

    Mustard F: Investing in the Early Years. 2008, Thinker in Residence: Adelaide

    Google Scholar 

  16. 16.

    Perry BD, Pollard RA, Blakley TL, Baker WL, Vigilante D: Childhood trauma, the neurobiology of adaptation and ‘use-dependent’ development of the brain: how states become traits. Infant Mental Health J. 1995, 16: 271-291. 10.1002/1097-0355(199524)16:4<271::AID-IMHJ2280160404>3.0.CO;2-B.

    Article  Google Scholar 

  17. 17.

    National Forum on early Childhood Program Evaluation: A Science-Based Framework for Early Childhood Policy. 2007, Cambridge MA: Harvard University

    Google Scholar 

  18. 18.

    National Health and Hospitals Reform Commission: A Healthier Future for All Australians: Final Report. 2009,$File/Final_Report_of_the%20nhhrc_June_2009.pdf,

    Google Scholar 

  19. 19.

    Beck CT: The effects of postpartum depression on child development: a meta-analysis. Arch Psychiatr Nurs. 1998, 7: 12-20.

    Article  Google Scholar 

  20. 20.

    Grace SL, Evindar A, Stewart DE: The effect of postpartum depression on child cognitive development and behavior: a review and critical analysis of the literature. Arch Women’s Ment Health. 2003, 6: 263-274. 10.1007/s00737-003-0024-6.

    CAS  Article  Google Scholar 

  21. 21.

    Hay DF, Pawlby S, Sharp D, Asten P, Mills A, Kumar R: Intellectual problems shown by 11‒year‒old children whose mothers had postnatal depression. J Child Psychol Psychiatry. 2001, 42: 871-889. 10.1111/1469-7610.00784.

    CAS  Article  PubMed  Google Scholar 

  22. 22.

    Pawlby S, Sharp D, Hay D, O’Keane V: Postnatal depression and child outcome at 11 years: the importance of accurate diagnosis. J Affect Disord. 2008, 107: 241-245. 10.1016/j.jad.2007.08.002.

    Article  PubMed  Google Scholar 

  23. 23.

    Bernier A, Carlson SM, Whipple N: From external regulation to self-regulation: early parenting precursors of young children’s executive functioning. Child Devel. 2010, 81: 326-339. 10.1111/j.1467-8624.2009.01397.x.

    Article  Google Scholar 

  24. 24.

    Murray L, Sinclair D, Cooper P, Ducournau P, Turner P, Stein A: The socioemotional development of 5-year-old children of postnatally depressed mothers. J Child Psychol Psychiatry. 1999, 40: 1259-1271. 10.1111/1469-7610.00542.

    CAS  Article  PubMed  Google Scholar 

  25. 25.

    Murray L, Cooper PJ: Postpartum Depression and Child Development. 1997, New York: Guilford

    Google Scholar 

  26. 26.

    Murray L, Cooper PJ: The impact of postpartum depression on child development. Aetiological Mechanisms in Developmental Psychopathology. Edited by: Goodyer L. 2003, Oxford: Oxford University Press

    Google Scholar 

  27. 27.

    NICHD Early Child Care Research Network: Chronicity of maternal depressive symptoms, maternal sensitivity, and child functioning at 36 months. Devel Psychol. 1999, 35: 1297-1310.

    Article  Google Scholar 

  28. 28.

    Stams GJ, Juffer F, van IJzendoorn MH: Maternal sensitivity, infant attachment, and temperament in early childhood predict adjustment in middle childhood: the case of adopted children and their biologically unrelated parents. Dev Psychol. 2002, 38: 806-821.

    Article  PubMed  Google Scholar 

  29. 29.

    Feldman R: The relational basis of adolescent adjustment. Attach Human Devel. 2010, 12: 173-192. 10.1080/14616730903282472.

    Article  Google Scholar 

  30. 30.

    Cairns RB, Cairns BD, Xie H, Leung MC, Hearne S: Paths across generations: academic competence and aggressive behaviors in young mothers and their children. Dev Psychol. 1998, 34: 1162-

    CAS  Article  PubMed  Google Scholar 

  31. 31.

    Stein A, Gath DH, Bucher J, Bond AD, Cooper PJ: The relationship between postnatal depression and mother-child interaction. Br J Psychiatry. 1991, 158: 46-52. 10.1192/bjp.158.1.46.

    CAS  Article  PubMed  Google Scholar 

  32. 32.

    Mount KS, Crockenberg SC, Barrig Jo PS, Wager JL: Maternal and child correlates of anxiety in 21/2 year old children. Infant Behav Dev. 2010, 33: 567-578. 10.1016/j.infbeh.2010.07.008.

    Article  PubMed  Google Scholar 

  33. 33.

    Feldman R, Greenbaum CW, Yirmiya N: Mother-infant affect synchrony as an antecedent of the emergence of self-control. Dev Psychol. 1999, 35: 223-231.

    CAS  Article  PubMed  Google Scholar 

  34. 34.

    Coyl DD, Roggman LA, Newland LA: Stress, maternal depression, and negative mother–infant interactions in relation to infant attachment. Infant Ment Health J. 2002, 23: 145-163. 10.1002/imhj.10009.

    Article  Google Scholar 

  35. 35.

    Berlin LJ, Ziv Y, Amaya-Jackson L, Greenberg MT: Enhancing Early Attachments: Theory, Research, Intervention and Policy. 2007, New York, NY: Guilford Press

    Google Scholar 

  36. 36.

    Fearon RP, Bakermans‒Kranenburg MJ, Van IJzendoorn MH, Lapsley AM, Roisman GI: The significance of insecure attachment and disorganization in the development of children’s externalizing behavior: a meta‒analytic study. Child Dev. 2010, 81: 435-456. 10.1111/j.1467-8624.2009.01405.x.

    Article  PubMed  Google Scholar 

  37. 37.

    Field T, Sandberg D, Garcia R, Vega-Lahr N, Goldstein S, Guy L: Pregnancy problems, postpartum depression and early mother-infant interactions. Dev Psychol. 1985, 21: 1152-1156.

    Article  Google Scholar 

  38. 38.

    Campbell SB, Matestic P, von Stauffenberg C, Mohan R, Kirchner T: Trajectories of maternal depressive symptoms, maternal sensitivity, and children’s functioning at school entry. Dev Psychol. 2007, 43: 1202-

    Article  PubMed  Google Scholar 

  39. 39.

    Penman R, Meares R, Baker K, Milgrom-Friedman J: Synchrony in mother-infant interaction: a possible neuropsychological base. Br J Medical Psychol. 1983, 56: 1-9. 10.1111/j.2044-8341.1983.tb01527.x.

    Article  Google Scholar 

  40. 40.

    Penman R, Meares R, Milgrom-Friedman J: Some origins of the difficult child. Recent Developments in Child Development and Child Psychiatry. Edited by: Chess S, Thomas A. 1984, New York: Brunner-Mazel

    Google Scholar 

  41. 41.

    Halligan SL, Murray L, Martins C, Cooper PJ: Maternal depression and psychiatric outcomes in adolescent offspring: a 13-year longitudinal study. J Affect Disord. 2007, 97: 145-154. 10.1016/j.jad.2006.06.010.

    Article  PubMed  Google Scholar 

  42. 42.

    Korhonen M, Luoma I, Salmelin R, Tamminen T: A longitudinal study of maternal prenatal, postnatal and concurrent depressive symptoms and adolescent well-being. J Affect Disord. 2012, 136: 680-692. 10.1016/j.jad.2011.10.007.

    Article  PubMed  Google Scholar 

  43. 43.

    Milgrom J, McCloud P: Parenting stress and postnatal depression. Stress Med. 1996, 12: 177-186. 10.1002/(SICI)1099-1700(199607)12:3<177::AID-SMI699>3.0.CO;2-W.

    Article  Google Scholar 

  44. 44.

    Horowitz JA, Bell M, Trybulski J, Munro BH, Moser D, Hartz SA, Sokol ES: Promoting responsiveness between mothers with depressive symptoms and their infants. J Nurs Scholarsh. 2001, 33: 323-329. 10.1111/j.1547-5069.2001.00323.x.

    CAS  Article  PubMed  Google Scholar 

  45. 45.

    Clark RH, Thomas P, Peabody J: Extrauterine growth restriction remains a serious problem in prematurely born neonates. Pediatrics. 2003, 111: 986-990. 10.1542/peds.111.5.986.

    Article  PubMed  Google Scholar 

  46. 46.

    Clark R, Tluczek A, Wenzel A: Psychotherapy for postpartum depression: a preliminary report. Am J Orthopsychiatry. 2003, 73: 441-

    Article  PubMed  Google Scholar 

  47. 47.

    Cooper PJ, Landman M, Tomlinson M, Molteno C, Swartz L, Murray L: Impact of a mother—infant intervention in an indigent peri-urban South African context pilot study. Br J Psychiatry. 2002, 180: 76-81. 10.1192/bjp.180.1.76.

    Article  PubMed  Google Scholar 

  48. 48.

    Gelfand DM, Teti DM, Seiner SA, Jameson PB: Helping mothers fight depression: evaluation of a home-based intervention program for depressed mothers and their infants. J Clin Child Psychol. 1996, 25: 406-422. 10.1207/s15374424jccp2504_6.

    Article  Google Scholar 

  49. 49.

    Lyons‒Ruth K, Connell DB, Grunebaum HU, Botein S: Infants at social risk: maternal depression and family support services as mediators of infant development and security of attachment. Child Dev. 1990, 61: 85-98. 10.2307/1131049.

    Article  Google Scholar 

  50. 50.

    Onozawa K, Glover V, Adams D, Modi N, Kumar RC: Infant massage improves mother–infant interaction for mothers with postnatal depression. J Affect Disord. 2001, 63: 201-207. 10.1016/S0165-0327(00)00198-1.

    CAS  Article  PubMed  Google Scholar 

  51. 51.

    Ammaniti M, Speranza AM, Tambelli R, Muscetta S, Lucarelli L, Vismara L, Cimino S: A prevention and promotion intervention program in the field of mother–infant relationship. Infant Ment Health J. 2006, 27: 70-90. 10.1002/imhj.20081.

    Article  Google Scholar 

  52. 52.

    Cicchetti D, Toth SL, Rogosch FA: The efficacy of toddler-parent psychotherapy to increase attachment security in offspring of depressed mothers. Attach Hum Dev. 1999, 1: 34-66. 10.1080/14616739900134021.

    CAS  Article  PubMed  Google Scholar 

  53. 53.

    Field TJ, Pickens J, Prodromidis M, Malphurs J, Fox N, Bendell D, Kuhn C: Targeting adolescent mothers with depressive symptoms for early intervention. Adolescence. 2000, 35: 381-414.

    CAS  PubMed  Google Scholar 

  54. 54.

    Toth SL, Rohosch FA, Manly JT, Cicchetti D: The efficacy of toddler-parent psychotherapy to reorganize attachment in the young offspring of mothers with major depressive disorder: a randomized preventative trial. J Consult Clin Psychol. 2006, 74: 1006-1016.

    Article  PubMed  Google Scholar 

  55. 55.

    Lewinsohn PM, Antonuccio DO, Steinmetz J, Teri L: The Coping with Depression Course: A Psychoeducational Intervention for Unipolar Depression. 1984, Eugene, OR: Castalsa Publishing Company

    Google Scholar 

  56. 56.

    Olioff M: The application of cognitive therapy to postpartum depression. The Challenge of Cognitive Therapy: Applications of non-traditional populations. Edited by: Vallis JL, Howes TM, Miller PC. 1991, New York: Plenum Press, 111-133.

    Chapter  Google Scholar 

  57. 57.

    Forman DR, O’Hara MW, Stuart S, Gorman LL, Larsen KE, Coy KC: Effective treatment for postpartum depression is not sufficient to improve the developing mother–child relationship. Dev Psychopathol. 2007, 19: 585-602.

    Article  PubMed  Google Scholar 

  58. 58.

    Schulz KF, Altman DG, Moher D: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2001, 8: 18-

    Article  Google Scholar 

  59. 59.

    Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Lancet. 2001, 357: 1191-1194. 10.1016/S0140-6736(00)04337-3.

    CAS  Article  PubMed  Google Scholar 

  60. 60.

    Murray D, Cox JL: Screening for depression during pregnancy with the Edinburgh Depression Scale (EPDS). J Reprod Infant Psychol. 1990, 8: 99-107. 10.1080/02646839008403615.

    Article  Google Scholar 

  61. 61.

    Whooley MA, Avins AL, Miranda J, Browner WS: Case-finding instruments for depression. J Gen Intern Med. 1997, 12: 439-445. 10.1046/j.1525-1497.1997.00076.x.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  62. 62.

    First MB, Spitzer RL, Gibbon M, Williams JBW: User’s guide for the Structured Clinical Interview for DSM-IV. 1997, Washington: American Psychiatric Press

    Google Scholar 

  63. 63.

    Beck AT, Steer RA, Garbin MG: Psychometric properties of the BDI. Clin Psych Rev. 1988, 8: 77-100. 10.1016/0272-7358(88)90050-5.

    Article  Google Scholar 

  64. 64.

    Abidin RR: Parenting Stress Index: Professional Manual (3rd Ed). 1995, Odessa, FL: Psychological Assessment Resources, Inc

    Google Scholar 

  65. 65.

    Clark R: The Parent–child early Relational Assessment: Instrument and Manual. 1985, Madison: University of Wisconsin Medical School, Department of Psychiatry

    Google Scholar 

  66. 66.

    Brockington IF, Fraser C, Wilson D: Postpartum bonding questionnaire: a validation. Arch Wom Ment Health. 2006, 9: 233-242. 10.1007/s00737-006-0132-1.

    CAS  Article  Google Scholar 

  67. 67.

    Sanson A, Prior M, Garino E, Oberklaid F, Sewell J: The structure of infant temperament: factor analysis of the Revised Infant Temperament Questionnaire. Infant Behav Dev. 1987, 10: 97-104. 10.1016/0163-6383(87)90009-9.

    Article  Google Scholar 

  68. 68.

    Sewell J, Oberklaid F, Prior M, Sanson A, Kyrios M: Temperament in Australian toddlers. J Paediatr Child Health. 1988, 24: 343-345. 10.1111/j.1440-1754.1988.tb01385.x.

    CAS  Article  Google Scholar 

  69. 69.

    Bricker D, Squires J: Ages and Stages Questionnaire: A parent-completed, chuld-monitoring system. 1999, Baltimore: Paul H. Brookes Publishing Co, 2

    Google Scholar 

  70. 70.

    Squires J, Bricker D, Twombly E, (with Yockelson S, Davis MS & KimY): The ASQ:SE User’s Guide. 2002, Baltimore: Paul H. Brookes Publishing Co

    Google Scholar 

  71. 71.

    Milgrom J, Martin P, Negri L: Treating Postnatal Depression. A Psychological Approach for Health Care Practitioners. 1999, Chichester: John Wiley & Sons

    Google Scholar 

  72. 72.

    Milgrom J, Negri LM, Gemmill AW, McNeil M, Martin PR: A randomized controlled trial of psychological interventions for postnatal depression. Br J Clin Psychol. 2005, 44: 529-542. 10.1348/014466505X34200.

    Article  PubMed  Google Scholar 

  73. 73.

    Fraiberg S: Clinical Studies in Infant Mental Health. 1980, New York: Basic books

    Google Scholar 

  74. 74.

    Schafer JL: Multiple imputation: a primer. Stat Methods Med Res. 1999, 8: 3-15. 10.1191/096228099671525676.

    CAS  Article  PubMed  Google Scholar 

  75. 75.

    Beyondblue: Clinical Practice Guidelines For Depression And Related Disorders – Anxiety, Bipolar Disorder And Puerperal Psychosis – In The Perinatal Period. A Guideline For Primary Care Professionals. 2011, Melbourne: Beyondblue

    Google Scholar 

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This work is supported by a grant from BeyondBlue. The authors wrote the protocol for this study with assistance from Dr Natalie Rose and Dr Alan Gemmill. Rachel Watts, Dr Jessica Ross and Jo du Buisson are responsible for delivering the intervention.

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Correspondence to Jeannette Milgrom.

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Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

JM and CH were responsible for the development of the study design and the funding. JM was responsible for the development of the intervention and the training of the psychologists. CH is the trial coordinator responsible for the ongoing management of the trial. Both authors have read and approved the final manuscript.

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Milgrom, J., Holt, C. Early intervention to protect the mother-infant relationship following postnatal depression: study protocol for a randomised controlled trial. Trials 15, 385 (2014).

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  • Postnatal depression
  • Mother-infant difficulties
  • Randomised controlled trial