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Table 5 Data collection schedule and measures

From: Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT)

Variable (Measure)

Timing of measures

 

Baseline

6 to 8 weeks post-randomization (pregnancy)

3 months postpartum

6 months postpartum

12 months postpartum

PHASE I

  

Demographics (education, income, maternal age at recruitment, ethnicity) (Items from Maternity Experiences Survey, bMES [120])

X

    

Obstetric and medical history (parity, chronic and pregnancy complications, type of delivery, weight - pre-pregnancy, delivery, 6 weeks postpartum) (Items from MES)

X

 

X

  

Mental health history (history of depression, anxiety, stress; age of onset of previous episodes of mental health problems) (Items from MES)

X

    

Pharmacologic therapy for depression/anxiety (past; current) (Items from Canadian Community Health Survey, CCHS)

X

X

X

X

X

Social support (Interpersonal Support Evaluation List, ISEL [121])

X

X

X

X

X

Prenatal depression, anxiety, stress symptoms (Depression, Anxiety, and Stress Scale, DASS-21 [107] - presence (percent above cut-off point) and severity (mean score, standard deviation)

X

X

   

Postnatal depression, anxiety, stress symptoms (Depression, Anxiety, and Stress Scale, DASS-21 [107] - presence (percent above cut-off point) and severity (mean score, standard deviation)

X

X

X

X

X

aPsychosocial assessment (Antenatal Risk Questionnaire-Revised, ANRQ-R; includes substance use and violence) [1, 31]

X

X

X

X

X

Depression (Edinburgh Postnatal Depression Scale, EPDS) [111]

X

X

X

X

X

aANRQ-R acceptability

X

    

Mastery (Pearlin’s Mastery Scale) [122]

X

X

X

X

X

Self-efficacy (Generalized Self-Efficacy Scale) [123]

X

X

X

X

X

Self-esteem [124]

X

X

X

X

X

Resilience (Connor-Davidson Resilience Scale) [91]

X

X

X

X

X

Sleep (Pittsburgh Sleep Quality Index) [125, 126]

X

X

X

X

X

Parenting competence (Parenting Sense of Competence Scale, PSCS; subscales Efficacy, Interest, Satisfaction) [127]

  

X

X

X

Parenting stress (Parental Stress Scale) [128]

  

X

X

X

Relationship quality and adjustment (Dyadic Adjustment Scale, DAS-7) [7, 129]

X

X

X

X

X

Coping (Brief Cope) [130]

X

X

X

X

X

Maternal-infant attachment (Condon and Corkindale) [131]

  

X

X

X

Infant behavior (Infant Behavior Questionnaire) [132]

  

X

X

X

Infant development (Ages and Stages Questionnaire, 3rd edition, ASQ-3; The Baby Pediatric Symptom Checklist for Social/Emotional Screening) [91, 133]

  

X

X

X

Birth weight (medical record)

  

X

  

Gestational age (medical record)

  

X

  

5-minute Apgar score (medical record)

  

X

  

Other factors related to infant outcomes: feeding method (medical record and parent-report); neonatal/infant health (medical record and parent-report) (Parent report items from the All Our Babies birth cohort studyc)

  

X

X

X

Patient diaries [134] (For economic analysis - including health service use, medication use, productivity loss, personal cost)

X

X

X

X

X

Quality of life (For economic analysis - SF-36,SF-6D to calculate QALY) [135]

X

X

X

X

X

Efficiency of intervention (percent of women with psychosocial assessment, referral, and care in IG versus CG; self-report and medical record)

  

X

X

X

Utility of intervention (one question asked at the end of each cognitive behavior therapy (CBT) homework exercise: This exercise was useful to me with four response options of I strongly agree, I somewhat agree, I somewhat disagree, I strongly agree; one question asked at the end of each CBT module: The information in this module was useful to me with same response options)

 

X

   

Usability of intervention (one question asked at the end of each CBT homework exercise: This exercise was clear and easy to understand with response options; 2 questions asked at the end of each module: 1) The information in this module was clear and easy to understand; 2) It was easy to work through the module (for example, it was easy for me to get from one part to the other, easy to find what I needed) with same response options)

 

X

   

Acceptability: Tablet-based psychosocial assessment (one question at end of completing ANRQ-R: I would recommend a tablet-based approach to asking about emotional health to a pregnant friend with four response options of I strongly agree, I somewhat agree, I somewhat disagree, I strongly agree)

X

    

Acceptability: CBT (one question at end of each CBT module: I would recommend this module to a pregnant friend who was struggling with stress, depression, or anxiety with 4 response options of I strongly agree, I somewhat agree, I somewhat disagree, I strongly agree)

 

X

   

Overall assessment (two open-ended questions at the end of every CBT module: 1) The thing I liked most about this module was….; 2) The thing I liked least about this module was….)

 

X

   

Log of interactions with participants (completed by research nurse)

X

X

X

  

PHASE 2

  

Efficiency (Providers’ views of the efficiency of the process of clinic-based online psychosocial assessment)

  

X

  

Utility (Women’s views of how useful the modules in were in meeting their needs)

     

Usability (Women’s views of how easy/difficult the modules were to navigate)

  

X

  

Feasibility (providers’ views of feasibility of conducting integrated intervention in their setting; women’s views of the feasibility of doing the modules; Google Analytics for example, percent of women accessing CBT within 2 weeks postassessment; percent of women accessing each CBT module within 1 to 2 weeks; percent completion of all six CBT modules; percent completion of CBT modules within 8 weeks)

  

X

  

Acceptability (women’s and providers’ views of acceptability/ability to promote disclosure)

  

X

  

Mechanisms (women’s views of why and how the intervention did/did not improve outcomes; how the intervention benefitted/did not benefit them)

  

X

  
  1. aIntervention group.
  2. bThe Maternity Experiences Survey (MES) is a national survey designed and administered by the Public Health Agency of Canada and Statistics Canada. The survey was designed through an exhaustive process involving discussion, consultation, literature reviews, focus group testing, and two pilot studies [120].
  3. cThe ‘All Our Babies Birth Cohort’ study is a pregnancy birth cohort in Alberta, Canada. Details of the study methodology and design have been previously published [136].