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

Parent-Child Relations Clinical Trial

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

Status Recruiting

Clinical Trial 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?

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Child Maltreatment
• Child Mental Disorder
• Mental Disorders
• Neurodevelopmental Disorders
• Parent-Child Relations

• NCT number: NCT06003582
• Study type: Interventional
• Source: University of Glasgow
• Contact: Helen Minnis, PhD
• Phone: +44 0141 201 9239
• Email: Helen.Minnis@glasgow.ac.uk
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 18, 2023
• Completion date: November 2023