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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-18

Study Completion Date

2025-02-28

Brief Summary

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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?

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Detailed Description

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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.

Conditions

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Parent-Child Relations Child Mental Disorder Child Maltreatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Infant mental health service

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Infant Parent Support

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

Group Type EXPERIMENTAL

Infant Parent Support

Intervention Type OTHER

Therapeutic Intervention

Services As Usual

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Infant Parent Support

Therapeutic Intervention

Intervention Type OTHER

Eligibility Criteria

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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

* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes