Family-Centred ACT After Paediatric ABI

NCT ID: NCT07303075

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-05
• Study Completion Date: 2026-06-27

Brief Summary

Children and young people with acquired brain injury (ABI) commonly experience long-term emotional, behavioural, and participation difficulties that can affect quality of life for both them and their families. Parents and caregivers also often experience high levels of stress and reduced wellbeing. Despite these needs, family-centred psychological interventions remain limited. Acceptance and Commitment Therapy (ACT) is a values-focused cognitive-behavioural approach designed to increase psychological flexibility and has shown promise for children with long-term health conditions and for parents of children with ABI, but it has not been directly evaluated as a joint therapeutic approach for children with ABI and their parents.

This study (Family CARE-ABI) evaluates the feasibility, acceptability, and preliminary effectiveness of delivering ACT simultaneously to a young person aged 11-18 with an ABI and their parent/guardian. Up to six dyads will be recruited. The study uses a non-concurrent, multiple-baseline, single-case experimental design in which dyads are randomised to begin a 12-week ACT intervention after either a 3- or 4-week baseline period. Sessions (up to 12, one hour each) are delivered via Microsoft Teams by a trainee clinical psychologist under specialist supervision. Therapy integrates the DNA-V model of ACT-developed for young people-with ABI-specific psychoeducation and skills practice tailored to each dyad's needs.

Outcome measures include mental health and wellbeing (Outcome Rating Scale), psychological flexibility (CompACT or AFQ-Y8), symptoms of anxiety and depression (GAD-7, PHQ-9, or RCADS-25), community participation (CASP/CASP-Y), and needs after ABI (MANTIC). Measures are collected at baseline, post-intervention, and 12-week follow-up, with weekly wellbeing ratings throughout participation. Therapeutic alliance (SRS) is obtained after each intervention session. All dyads will also take part in separate qualitative interviews exploring their experiences of the intervention and its impact.

Safety is closely monitored, including assessment of distress, adverse events, and any safeguarding concerns. Participation is voluntary, and dyads may withdraw at any time without affecting usual care. Data are stored securely and anonymised for analysis.

The study aims to generate early evidence regarding whether family-centred ACT may support psychological wellbeing, flexibility, and participation for young people with ABI and their parents, and to inform future intervention development and larger-scale trials.

Conditions

Acquired Brain Injury

Keywords

Paediatric; Acceptance and Commitment Therapy; Psychological Flexibility; Acquired Brain Injury; Traumatic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

The only arm of the study - dyads will receive treatment (ACT)

Group Type: EXPERIMENTAL

Acceptance and Commitment Therapy (DNA-V)

Intervention Type: OTHER

Family-Centred ACT for ABI will begin with a needs assessment and comprise needs- and ABI-specific psychoeducation and ACT principles using the DNA-V model of ACT.

Interventions

Acceptance and Commitment Therapy (DNA-V)

Family-Centred ACT for ABI will begin with a needs assessment and comprise needs- and ABI-specific psychoeducation and ACT principles using the DNA-V model of ACT.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged 11 to 18 years at time of recruitment.
• Living at home with parent/guardian.
• Received treatment for an ABI.
• Have sufficient cognitive ability to engage with therapy sessions.
• Has capacity to provide verbal or written informed consent (aged 16 and above) or assent (aged 15 and younger).
• Has the ability to speak sufficient English to understand and engage with the therapeutic and research materials
• Consents for parent/guardian participant involvement in study.

• Aged > 18 at time of recruitment. There is no upper age limit.
• Has the ability to speak sufficient English to understand and engage with the therapeutic and research materials
• Has capacity to provide verbal or written informed consent for self and CYP participant.

Exclusion Criteria

• CYP or parent participants are currently accessing or have accessed structured psychological intervention within 6 months of study recruitment.

• Minimum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

24080

Identifier Type: -

Identifier Source: org_study_id