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

University of Glasgow

Status: Active, not recruiting

Conditions: Parent-Child Relations; Child Maltreatment; Child Mental Disorder

Treatments: Other: Infant Parent Support

Study type: Interventional

Funder types: Other

Identifiers

NCT06003582

316250

Details and patient eligibility

About

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?

Full 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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Infant Parent Support

Experimental group

Description:

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

Treatment:

Other: Infant Parent Support

Services As Usual

No Intervention group

Description:

Families randomised to Services As Usual, engage with already existing services.