Parent-Child RelationsNCT06003582
Co-production and Feasibility RCT of Intervention to Improve the Mental Health of Children With a Social Worker
A study testing Infant Parent Support in people with Parent-Child Relations and Child Mental Disorder, run by University of Glasgow at 1 site in United Kingdom.
Trial 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? Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations, Child Mental Disorder, Child Maltreatment
- What is being tested?
- Infant Parent Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 May 2023to Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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?
Read the 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.
- Being tested
- Infant Parent Support
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Parent SupportOther
Therapeutic Intervention
| Study group | Role | What they receive |
|---|---|---|
| Infant Parent Support | Experimental | Families engage with the new therapeutic intervention, Infant Parent Support. Receives: Other: Infant Parent Support |
| Services As Usual | No intervention | Families randomised to Services As Usual, engage with already existing services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start18 May 2023
- Primary completion30 Sep 2024
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Infant mental health service
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- National Society for the Prevention of Cruelty to Children, Glasgow City Council, London Borough of Bromley, University of Nottingham, Queen Mary University of London
- Responsible party
- Principal investigator, Helen Minnis, University of Glasgow
- Investigators
- Helen Minnis, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003582
- Sponsor's protocol ID
- 316250
- Status last verified
- Jan 2025
- First submitted
- 11 May 2023
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40474316
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06003582
- Acronym / sponsor ID
- 316250
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- National Society for the Prevention of Cruelty to Children, Glasgow City Council, London Borough of Bromley, University of Nottingham, Queen Mary University of London
- Study start
- 18 May 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- Feb 2025 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Infant mental health service
| Arm | Type | Receives |
|---|---|---|
| Infant Parent Support | Experimental | Other: Infant Parent SupportFamilies engage with the new therapeutic intervention, Infant Parent Support. |
| Services As Usual | No intervention | –Families randomised to Services As Usual, engage with already existing services. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant Parent SupportTherapeutic Intervention | Other | Infant Parent Support |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Derived from this study: PubMed 40474316Pownall 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Minnis, PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Parent Support in people with Parent-Child Relations and Child Mental Disorder, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates to a feasibility RCT (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06003582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.