Acquired Brain InjuryFamilyCARE-ABINCT07303075
Family-Centred ACT After Paediatric ABI
A study testing Acceptance and Commitment Therapy (DNA-V) in people with Acquired Brain Injury, run by University of Nottingham.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Acceptance and Commitment Therapy (DNA-V)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 5 Dec 2025to 27 Jun 2026
- 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 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- CYP-ABI and parent participant exclusion criteria include:
- CYP or parent participants are currently accessing or have accessed structured psychological intervention within 6 months of study recruitment.
About this study
Official title: Family-Centred Acceptance and Commitment Therapy After Paediatric Acquired Brain Injury
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.
Read more
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
- Being tested
- Acceptance and Commitment Therapy (DNA-V)
- Keywords
- Paediatric, Acceptance and Commitment Therapy, Psychological Flexibility, Acquired Brain Injury, Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (DNA-V)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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | The only arm of the study - dyads will receive treatment (ACT) Receives: Other: Acceptance and Commitment Therapy (DNA-V) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Rating Scale
Measure of wellbeing
Measured: From enrollment to the end of the study at 24 weeks
Secondary outcomes (7)
CompACT
Measure of psychological flexibility for adults
Measured: Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
Avoidance and Fusion Questionnaire
Measure of psychological flexibility for children
Measured: Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
GAD & PHQ9
Measures of adult anxiety and depression
Measured: Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
RCADS
Measure of child anxiety and depression
Measured: Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
CASP/CASP-Youth Version
Measure of child participation
Measured: Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
MANTIC
Measure of needs after acquired brain injury
Measured: Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
Session Rating Scale
Measure of therapeutic alliance
Measured: Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start5 Dec 2025 (estimated)
- Primary completion27 Jun 2026 (estimated)
- Study completion27 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303075
- Sponsor's protocol ID
- 24080
- Acronym
- FamilyCARE-ABI
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Centred Acceptance and Commitment Therapy After Paediatric Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT07303075
- Acronym / sponsor ID
- FamilyCARE-ABI / 24080
- Conditions
- Acquired Brain Injury
- Keywords
- Paediatric, Acceptance and Commitment Therapy, Psychological Flexibility, Acquired Brain Injury, Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Study start
- 5 Dec 2025 (estimated)
- Primary completion
- 27 Jun 2026 (estimated)
- Study completion
- 27 Jun 2026 (estimated)
- First posted
- 24 Dec 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Acceptance and Commitment Therapy (DNA-V)The only arm of the study - dyads will receive treatment (ACT) |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- CYP or parent participants are currently accessing or have accessed structured psychological intervention within 6 months of study recruitment.
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 |
|---|---|---|
| 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. | Other | Treatment Group |
Primary outcome
Outcome Rating Scale
Time frame: From enrollment to the end of the study at 24 weeks
Measure of wellbeing
7 secondary outcomes
CompACT
Time frame: Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
Avoidance and Fusion Questionnaire
Time frame: Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
GAD & PHQ9
Time frame: Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
RCADS
Time frame: Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
CASP/CASP-Youth Version
Time frame: Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
MANTIC
Time frame: Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
Session Rating Scale
Time frame: Baseline (week 1), following therapy (week 15 or 16), at follow-up (week 24)
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 24 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (DNA-V) in people with Acquired Brain Injury, run by University of Nottingham.
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 0 inclusion and 2 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: opening soon, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Outcome Rating Scale (time frame: From enrollment to the end of the study at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2025.