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NCT Number: NCT06003582

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

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?

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This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Borough of Bromley

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Infant Parent Support

Other

Therapeutic Intervention

Primary outcomes

  1. Recruitment rates to a feasibility RCT

    Time frame: 6 months

    The recruitment of 30 families to the Trial and the 15 families randomised to the new therapeutic intervention will be measured by recruitment rates.

  2. Retention rates to a feasibility RCT

    Time frame: 1 year

    The proportion of the 15 families randomised to the new intervention who continue through the Trial will be measured by retention rates.

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 22, 2023
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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