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

Study Overview
=================
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.

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

Conditions
-----------------
Parent-Child Relations, Child Mental Disorder, Child Maltreatment

Intervention / Treatment
-----------------
* Other: Infant Parent Support


Participation Criteria
=================
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Infant mental health service
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infant Parent Support<br>Families engage with the new therapeutic intervention, Infant Parent Support. | Other: Infant Parent Support<br>* Therapeutic Intervention<br>|
| No Intervention: Services As Usual<br>Families randomised to Services As Usual, engage with already existing services. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |