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

NCT06003582 | Active Not Recruiting

• 1 other identifier: 316250
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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?

Conditions

Parent-Child Relations; Child Mental Disorder; Child Maltreatment

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Infant Parent Support

EXPERIMENTAL

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

Other: Infant Parent Support

Services As Usual

NO INTERVENTION

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

Interventions

Infant Parent Support OTHER

Therapeutic Intervention

Infant Parent Support

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Glasgow: lead
• National Society for the Prevention of Cruelty to Children: collaborator
• Glasgow City Council: collaborator
• London Borough of Bromley: collaborator
• University of Nottingham: collaborator
• Queen Mary University of London: collaborator

Study Sites (1)

London Borough of Bromley

London, United Kingdom

Location

Related Publications (1)

• Pownall J, Crawford K, Dalgarno L, Fisher J, Graham S, Turner F, Minnis H, Boyd K, Seyahian A, McConnachie A, Cosgrave N, Forde M, Atkinson C, McCullough J, Sayal K, Ougrin D. Infant Parent Support (IPS): a multidisciplinary intervention to improve the mental health of children with a social worker - a study protocol for a feasibility randomised controlled trial with embedded process evaluation. Pilot Feasibility Stud. 2025 Jun 5;11(1):78. doi: 10.1186/s40814-025-01616-6.

  PMID: 40474316 DERIVED

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Helen Minnis, PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Helen Minnis

Model Details: Infant mental health service

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: August 22, 2023
• Study Start: May 18, 2023
• Primary Completion: September 30, 2024
• Study Completion: February 1, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)