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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06003582
• Other study ID #: 316250
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 18, 2023
• Est. completion date: November 2023

Study information

• Verified date: August 2023
• Source: University of Glasgow
• Contact: Helen Minnis, PhD
• Phone: +44 0141 201 9239
• Email: Helen.Minnis[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Interventional

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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Infant Parent Support
Therapeutic Intervention

Locations

Country	Name	City	State
United Kingdom	London Borough of Bromley	London

Sponsors (6)

Lead Sponsor	Collaborator
University of Glasgow	Glasgow City Council, London Borough of Bromley, NSPCC, Queen Mary University of London, University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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