Co-production and Feasibility RCT of Intervention to Improve the Mental Health of Children With a Social Worker

Partnership for Change - Co-production and Feasibility Randomised Controlled Trial of an Intervention to Improve the Mental Health of Children With a Social Worker

Feasibility RCT to ask: Can the investigators coproduce, with parent collaborators, a new service, Infant Parent Support (IPS), to improve the mental health of children with a social worker? Can the investigators test the feasibility of an RCT of IPS compared with services as usual?

Study Overview

• Status: Active, not recruiting
• Conditions: Parent-Child Relations; Child Mental Disorder; Child Maltreatment
• Intervention / Treatment: Other: Infant Parent Support

Detailed Description

Questions addressed: Can the investigators coproduce, with parent collaborators, a new service, Infant Parent Support (IPS), to improve the mental health of children with a social worker? Can the investigators test the feasibility of an RCT of IPS compared with services as usual?

Considered for entry: Parents of children aged 0-5 who have mental health concerns, social workers, and a multi-agency support plan.

Inclusion criteria: Any family in the Glasgow or Bromley trial sites with a child aged 0-5 years with mental health concerns, a social worker, and a multi-agency support plan.

Exclusion criteria: At the outset of the Trial there were no exclusion criteria.

Over the course of Phase 1, the following exclusion criteria have emerged:

• If the child has a Child Protection Plan or is on the Child Protection Register
• If the family are in the process of 'stepping down' from a CPP or CPR
• If the child is currently engaged in therapeutic work.

Intervention: Infant Parent Support (a multidisciplinary infant mental health team aiming to improve the mental health of children aged 0-5 with a social worker).

Primary Outcomes Phase 1: Coproduction, with parents of children who have a social worker, of the IPS intervention.

Phase 2: Recruitment and retention (at 3 and 6 months) to a feasibility RCT.

Secondary Outcomes

Phase 1: preliminary mapping of service context.

Phase 2:

• Improvement in the organisation, access, and quality of services, for children with a social worker and mental health issues.
• Examination of putative primary and secondary outcomes for a future definitive RCT of IPS (see below)
• Development of a parent-supported outcome measure and a parent-supported experience measure for use in a future definitive RCT
• Exploration of whether it is possible to expand into new sites to conduct a successful Phase III trial.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • London Borough of Bromley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Any family in the Glasgow or Bromley trial sites with a child aged 0-5 years with mental health concerns, a social worker, and a multi-agency support plan.

Exclusion Criteria:

At the outset of the Trial there were no exclusion criteria. Over the course of Phase 1, the following exclusion criteria have emerged:

• If the child has a Child Protection Plan or is on the Child Protection Register
• If the family are in the process of 'stepping down' from a CPP or CPR
• If the child is currently engaged in therapeutic work.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infant Parent Support; Families engage with the new therapeutic intervention, Infant Parent Support.	Other: Infant Parent Support; Therapeutic Intervention
No Intervention: Services As Usual; Families randomised to Services As Usual, engage with already existing services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rates to a feasibility RCT	The recruitment of 30 families to the Trial and the 15 families randomised to the new therapeutic intervention will be measured by recruitment rates.	6 months
Retention rates to a feasibility RCT	The proportion of the 15 families randomised to the new intervention who continue through the Trial will be measured by retention rates.	1 year

Collaborators and Investigators

• Sponsor: University of Glasgow
• Collaborators: University of Nottingham; Queen Mary University of London; National Society for the Prevention of Cruelty to Children; Glasgow City Council; London Borough of Bromley
• Investigators: Principal Investigator: Helen Minnis, PhD, University of Glasgow

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders
• Other Study ID Numbers: 316250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No