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Table 3 World Health Organisation Trial Registration Data Set

From: Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial

Data category Information
Primary registry and trial identifying number ISRCTN: 21656568
Date of registration 28/02/2014
Secondary identifying numbers  
Sources of monetary or material support National Institute of Health Research (PHR Project: 11/3002/01) Chief Scientist Office and Scottish Government (GN12KH589 THRIVE)
Sponsor NHS Greater Glasgow and Clyde Health Board
Contact for public queries AM Alice.MacLachlan@glasgow.ac.uk
Contact for scientific queries MH Marion.Henderson@glasgow.ac.uk
Public Title THRIVE: Trial of Healthy Relationship Initiatives for the Very Early years
Scientific Title Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial
Countries of recruitment Scotland
Health conditions or problem studied Pregnancy with additional health and/or social care needs such as mental ill health, substance abuse, homelessness or domestic violence
Interventions Mellow Bumps Enhanced Triple P for Baby
Key inclusion criteria Pregnant, aged 16 and over with an additional health and/or social care need living in the geographical areas of NHS Greater Glasgow and Clyde and NHS Ayrshire and Arran
Key exclusion criteria 1. Difficulties understanding written and verbal English
2. Active psychosis
3. Homelessness
4. Child will be removed at birth
Study type Longitudinal randomised control trial
Date of first enrolment 30/01/2014
Target sample size 500
Recruitment status Recruitment complete
Primary outcomes 1) Do participants receiving ETPB plus CAU or MB plus CAU show significantly lower anxiety, depression and outwardly directed irritability compared to those receiving CAU alone when their infants are around 6 months old?
2) Do participants who receive ETPB plus CAU or MB plus CAU show more sensitive interactions with their infants compared to those receiving CAU alone when their infants are around 6 months old?
Key secondary outcomes 1) Do infants whose parent(s) receive ETPB plus CAU or MB plus CAU show more cooperative behaviour signs than those whose parent(s) received CAU alone?
2) Do ETPB or MB lead to changes in the number of children flagged as ‘at risk’ on the social services risk register, under a child protection plan, taken into local authority care or attending an accident and emergency department?
3) Do ETPB or MB lead to an improvement in the socio-emotional development of children at around 30 months old?
4) Do ETPB or MB lead to an improvement in language development in children at around 30 months?
5) Do ETPB or MB lead to an improvement in longer term educational and health outcomes for children?
6) Are either ETPB or MB cost-effective for the National Health Service (NHS) or society more broadly, in the long-term?
7) Do differences in programme fidelity; practitioners’ characteristics and motivation; mothers’ engagement; the intervention mechanisms; and contextual factors affect mother and infant outcomes?
8) Does fathers’ involvement or support affect mothers’ engagement with ETPB or MB?
9) How do participants’ experiences of being parented influence their own parenting values and behaviour?