Family-Centred ACT After Paediatric ABI

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11+
SponsorUniversity of Nottingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Acceptance and Commitment Therapy (DNA-V)

    Other intervention

    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.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Treatment GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Outcome Rating Scale

Measure of wellbeing

Time frame
From enrollment to the end of the study at 24 weeks

Secondary outcomes

1

CompACT

Measure of psychological flexibility for adults

Time frame
Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
2

Avoidance and Fusion Questionnaire

Measure of psychological flexibility for children

Time frame
Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
3

GAD & PHQ9

Measures of adult anxiety and depression

Time frame
Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
4

RCADS

Measure of child anxiety and depression

Time frame
Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nottingham

Lead sponsor

Nottingham University Hospitals NHS Trust

Collaborator

This trial is not recruiting at the moment. You can still explore other options: