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

Primary Purpose

Parent-Child Relations, Child Mental Disorder, Child Maltreatment

Status
Recruiting
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Infant Parent Support
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parent-Child Relations

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • London Borough of BromleyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Infant Parent Support

Services As Usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 11, 2023
Last Updated
August 14, 2023
Sponsor
University of Glasgow
Collaborators
NSPCC, Glasgow City Council, London Borough of Bromley, University of Nottingham, Queen Mary University of London
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1. Study Identification

Unique Protocol Identification Number
NCT06003582
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow
Collaborators
NSPCC, Glasgow City Council, London Borough of Bromley, University of Nottingham, Queen Mary University of London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parent-Child Relations, Child Mental Disorder, Child Maltreatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Infant mental health service
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Infant Parent Support
Arm Type
Experimental
Arm Description
Families engage with the new therapeutic intervention, Infant Parent Support.
Arm Title
Services As Usual
Arm Type
No Intervention
Arm Description
Families randomised to Services As Usual, engage with already existing services.
Intervention Type
Other
Intervention Name(s)
Infant Parent Support
Intervention Description
Therapeutic Intervention
Primary Outcome Measure Information:
Title
Recruitment rates to a feasibility RCT
Description
The recruitment of 30 families to the Trial and the 15 families randomised to the new therapeutic intervention will be measured by recruitment rates.
Time Frame
6 months
Title
Retention rates to a feasibility RCT
Description
The proportion of the 15 families randomised to the new intervention who continue through the Trial will be measured by retention rates.
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helen Minnis, PhD
Phone
+44 0141 201 9239
Email
Helen.Minnis@glasgow.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Judith Fisher, MSc
Phone
+44 0141 201 9239
Email
Judith.Fisher@glasgow.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Minnis, PhD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Borough of Bromley
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Whiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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