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

Not Applicable

Active, not recruiting

• Conditions: Parent-Child Relations; Child Maltreatment; Child Mental Disorder
• Interventions: Other: Infant Parent Support

• Registration Number: NCT06003582
• Lead Sponsor: University of Glasgow

Brief Summary

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?

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 Timeline

• Study First Submitted: 2023-05-11
• Study Start: 2023-05-18
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-22
• Primary Completion: 2024-09-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant Parent Support	Infant Parent Support	Families engage with the new therapeutic intervention, Infant Parent Support.

Primary Outcome Measures

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

Trial Locations

Locations (1)

London Borough of Bromley; 🇬🇧 London, United Kingdom