Clinical trial NCT06003582: Co-production and Feasibility RCT of Intervention to Improve the Mental Health of Children With a Social Worker
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parent-Child Relations
Child Mental Disorder
Child Maltreatment
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: National Society for the Prevention of Cruelty to Children
name: Glasgow City Council
name: London Borough of Bromley
name: University of Nottingham
name: Queen Mary University of London
First posted: 2023-08-22
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Infant mental health service
Primary purpose: TREATMENT

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?

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment rates to a feasibility RCT
timeFrame: 6 months
measure: Retention rates to a feasibility RCT
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London Borough of Bromley
Study officials:
affiliation: University of Glasgow
name: Helen Minnis, PhD
role: PRINCIPAL_INVESTIGATOR
References: