THRIVE: Trial of Healthy Relationships Initiatives for the Very Early years

Study design

The THRIVE study is a 3-arm longitudinal randomised controlled trial which will rigorously evaluate the efficacy of two parenting interventions, Enhanced Triple P for Baby and Mellow Bumps by comparing them against the routine care provided to vulnerable women during pregnancy (care as usual). This is a multi-component study which will collect the following data:

• baseline and follow up (x2) quantitative survey data from vulnerable mothers
• video recordings of mother-child interaction
• in-depth qualitative interviews with mothers
• in-depth qualitative interviews with partners
• video/audio recordings of practitioners delivering the interventions
• audit questionnaires on intervention delivery from practitioners
• in-depth interviews with practitioners delivering the interventions
• in-depth interviews with the supervisors of practitioners
• in-depth interviews with referring health and social care practitioners
• analysis of routinely collected data

The trial will be conducted within a number of NHS approved locations within the NHS Greater Glasgow and Clyde and NHS Ayrshire and Arran Health Board areas. Visits will also be made to the woman’s homes for data collection.

Questionnaires

The severity of any psychological distress across 9 dimensions will be measured using the Brief Symptom Inventory (BSI-53)
Health status will be measured using EQ-5D-3L: European Quality of Life- 5 dimensions, a generic measure of health, required for the economic evaluation.
Hospital Anxiety and depression scale enhanced by the outwardly–directed irritability questions from the Adult Wellbeing Scale (HADS+1).
Karitane Parenting Confidence Scale will be used to measure the mothers’ experiences of being a parent.
Language development will be measured using the Sure Start Language Measure.
An evaluation questionnaire will be completed by each mother after each support group.
Practitioners will complete post-session protocol adherence checklists and questionnaires on their expectations and experiences of taking part.
Long-term outcomes will be assessed by collecting data that is collected routinely as infants grow. These will be collected from measures such as the Strengths and Difficulties Questionnaire (SDQ) and the Sure Start Language Measure.

Research Findings

This study is currently recruiting.

The THRIVE Team

Chief Investigator: Dr. Marion Henderson

Researchers:
Karen Crawford: Project Manager
Dr. Catherine Nixon: Investigator Scientist
Shona Shinwell: Investigator Scientist
Dr. Rosaleen O’Brien: Research Associate
Helen Thompson: Trial Administrator
Karen Maxwell: PhD Student

Co-applicants

University of Glasgow
Prof. Daniel Wight
Dr. Katie Buston
Dr. Emma McIntosh
Dr. Kathleen Boyd
Dr. Alex McConnachie
Dr. Helen Minnis

Glasgow Caledonian University
Dr. Elizabeth McGee

Ayrshire and Arran Healthboard and University of Glasgow
Dr. John O'Dowd

University of Manchester
Dr. Anja Wittkowski
Prof. Rachel Calam

University of Newcastle
Prof. James Law

University of Aberdeen
Prof. Phil Wilson
Dr. Lucy Thompson

Steering Group:
Prof. Rudi Dallos (Chair)
Dr. Linda De Caestecker
Dr. Mary Hepburn
Dr. David Conway
Dr. Julia Quickfall
Prof. Ruth Freeman
Prof. David Tappin
Mary Glasgow
Anne Clark
Matt Forde
Elaine Moore
Sam Gillies (lay member)

Publications

This study has no publications to date.