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

Partnership for Change - Co-production and Feasibility Randomised Controlled Trial of an Intervention to Improve the Mental Health of Children With a Social Worker

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06003582
Enrollment
30
Registered
2023-08-22
Start date
2023-05-18
Completion date
2025-02-28
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Maltreatment, Child Mental Disorder, Parent-Child Relations

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.

Interventions

OTHERInfant Parent Support

Therapeutic Intervention

Sponsors

National Society for the Prevention of Cruelty to Children
CollaboratorOTHER
Glasgow City Council
CollaboratorUNKNOWN
London Borough of Bromley
CollaboratorUNKNOWN
University of Nottingham
CollaboratorOTHER
Queen Mary University of London
CollaboratorOTHER
University of Glasgow
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Intervention model description

Infant mental health service

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Recruitment rates to a feasibility RCT6 monthsThe recruitment of 30 families to the Trial and the 15 families randomised to the new therapeutic intervention will be measured by recruitment rates.
Retention rates to a feasibility RCT1 yearThe proportion of the 15 families randomised to the new intervention who continue through the Trial will be measured by retention rates.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026