Table 3 World Health Organisation Trial Registration Data Set
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 | |
Contact for scientific queries | |
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? |