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

• Sponsor: University of Glasgow (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06003582
• Collaborator: NSPCC (Other), Glasgow City Council (Other), London Borough of Bromley (Other), University of Nottingham (Other), Queen Mary University of London (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.5
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Parent-Child Relations; Child Mental Disorder; Child Maltreatment	Other: Infant Parent Support	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Infant mental health serviceInfant mental health service
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 18, 2023
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London Borough of Bromley	London		United Kingdom

Sponsors and Collaborators

• University of Glasgow
• NSPCC
• Glasgow City Council
• London Borough of Bromley
• University of Nottingham
• Queen Mary University of London

Investigators

• Principal Investigator: Helen Minnis, PhD, University of Glasgow

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Helen Minnis, Professor Helen Minnis, University of Glasgow
• ClinicalTrials.gov Identifier: NCT06003582
• Other Study ID Numbers: 316250
• First Posted: Aug 22, 2023
• Last Update Posted: Aug 22, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Mental Disorders; Neurodevelopmental Disorders

Study Results

No Results Posted as of Aug 22, 2023