Long-term Health ConditionsNCT07656220
An Acceptance and Commitment Therapy Psychoeducation Single Session Intervention on Childhood Anxiety for Carers of Children With a Long-Term Health Condition
A study testing Psychoeducation for anxiety in people with Long-term Health Conditions, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
The goal of this feasibility study was to assess the acceptability and feasibility of the ACT-based training package for carers of children with a long-term health condition (LTHC) who also experience anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long-term Health Conditions
- What is being tested?
- Psychoeducation for anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Oct 2025to 12 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary care giver of children aged 5-12 years
- The child has a long term health condition (LTHC)
Who cannot join
- Carers of children with a learning disability or waiting for an assessment for a learning disability, not including ADHD or dyslexia. This does however include Autism.
- Participants must be over 18
- Access to their own electronic device
- Not have sufficient proficiency in spoken English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of East Anglia (UEA)
Norwich, Norfolk, NR4 7UJ
About this study
The goal of this feasibility study was to assess the acceptability and feasibility of the ACT-based training package for carers of children with a long-term health condition (LTHC) who also experience anxiety.
The main aims were to answer:
Read more
Is the intervention feasible? Is the intervention acceptable?
The secondary aim were to answer:
Does the intervention impact how carers approach and manage their child's anxiety?
Participants completed two questionnaires, prior to watching the online training videos. They were then asked to complete another questionnaire. Two weeks later, participants were contacted via email to complete two questionnaires, one of which was a repeat from prior to completing the training.
Read the detailed description
This study aims to evaluate the feasibility and acceptability of a newly developed, single-session, online psychoeducational training designed to support caregivers in managing their child's anxiety associated with their long-term health condition (LTHC). The study also explored preliminary changes in caregiver knowledge and approaches to managing anxiety following the intervention.
This study used a quantitative, within-subjects feasibility design. Caregivers of children aged 5-12 years with a diagnosed long-term health condition were recruited. All participants received the intervention, with no control group.
The intervention consisted of a 22-minute online training package delivered via three videos. The content is based on ACT principles and includes psychoeducation about anxiety, ACT-based metaphors and exercises to consider using with their child. The material in the training was specifically designed to support children with a LTHC, rather than generic support for anxiety.
Participants completed measures prior to the intervention, including a demographic questionnaire and the Parent Attitudes, Beliefs and Understanding about Anxiety (PABUA). Immediately following the training, participants completed a structured feedback questionnaire assessing the acceptability and accessibility of the intervention. Two weeks after completing the training, participants were invited via email to complete follow-up measures, including a repeat of the PABUA and a follow-up feedback questionnaire to assess use and perceived usefulness of the strategies.
Feasibility outcomes include recruitment rates, retention rates, and participant-reported acceptability of the intervention and study procedures. Secondary outcomes include changes in caregiver knowledge, beliefs, and confidence in managing their child's anxiety (measured by the PABUA).
- Conditions
- Long-term Health Conditions
- Being tested
- Psychoeducation for anxiety
- Keywords
- Feasibility, ACT, Anxiety, Paediatrics, Caregivers, Parent-led interventions
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation for anxietyBehavioural
The intervention was made up of 3 videos, totalling 22 minutes. The videos incorporated psychoeducation on anxiety and Acceptance and Commitment Therapy (ACT) based skills for carers to consider using to support their child with anxiety. All material was based on children with long term health conditions.
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Experimental | All participants completed the intervention package. The intervention was made up of 3 online training videos lasted a total of 22 minutes. Receives: Behavioral: Psychoeducation for anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Feedback Questionnaire
Measure to assess the acceptability and feasibility of the training, for example assessing the consent process and format of the training. The measure uses a scale of strongly disagree (1) to strongly agree (5).
Measured: Immediately post-intervention
Follow-up Structured Feedback Questionnaire
Measure to assess barriers to engaging with the strategies since the training and reviewing usefulness of the strategies used. The measure uses a scale of strongly disagree (1) to strongly agree (5).
Measured: 2-week follow-up
Secondary outcomes (1)
Parent, Attitudes, Beliefs and Understanding about Anxiety (PABUA) (Wolk et al, 2016)
The measure was designed to evaluate parental beliefs about their child's anxiety, as well as their perceived ability to cope and manage their child's anxiety. The measure uses a scale of strongly disagree (1) to strongly agree (5).
Measured: Pre-intervention and 2-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start21 Oct 2025
- Primary completion12 Feb 2026
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-term Health ConditionsStudies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kiki Mastroyannopoulou, Senior Fellow of HEA, Study chair, University of East Anglia (UEA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656220
- Sponsor's protocol ID
- Harriet Leader-White
- Status last verified
- Mar 2026
- First submitted
- 6 May 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the sensitive nature of the data and potential risk of identification due to the small sample size.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Acceptance and Commitment Therapy Psychoeducation Single Session Intervention on Childhood Anxiety for Carers of Children With a Long-Term Health Condition
- ClinicalTrials.gov ID
- NCT07656220
- Acronym / sponsor ID
- Harriet Leader-White
- Conditions
- Long-term Health Conditions
- Keywords
- Feasibility, ACT, Anxiety, Paediatrics, Caregivers, Parent-led interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 18 Jun 2026 (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.
The goal of this feasibility study was to assess the acceptability and feasibility of the ACT-based training package for carers of children with a long-term health condition (LTHC) who also experience anxiety.
The main aims were to answer:
Is the intervention feasible? Is the intervention acceptable?
The secondary aim were to answer:
Does the intervention impact how carers approach and manage their child's anxiety?
Participants completed two questionnaires, prior to watching the online training videos. They were then asked to complete another questionnaire. Two weeks later, participants were contacted via email to complete two questionnaires, one of which was a repeat from prior to completing the training.
Detailed description
This study aims to evaluate the feasibility and acceptability of a newly developed, single-session, online psychoeducational training designed to support caregivers in managing their child's anxiety associated with their long-term health condition (LTHC). The study also explored preliminary changes in caregiver knowledge and approaches to managing anxiety following the intervention.
This study used a quantitative, within-subjects feasibility design. Caregivers of children aged 5-12 years with a diagnosed long-term health condition were recruited. All participants received the intervention, with no control group.
The intervention consisted of a 22-minute online training package delivered via three videos. The content is based on ACT principles and includes psychoeducation about anxiety, ACT-based metaphors and exercises to consider using with their child. The material in the training was specifically designed to support children with a LTHC, rather than generic support for anxiety.
Participants completed measures prior to the intervention, including a demographic questionnaire and the Parent Attitudes, Beliefs and Understanding about Anxiety (PABUA). Immediately following the training, participants completed a structured feedback questionnaire assessing the acceptability and accessibility of the intervention. Two weeks after completing the training, participants were invited via email to complete follow-up measures, including a repeat of the PABUA and a follow-up feedback questionnaire to assess use and perceived usefulness of the strategies.
Feasibility outcomes include recruitment rates, retention rates, and participant-reported acceptability of the intervention and study procedures. Secondary outcomes include changes in caregiver knowledge, beliefs, and confidence in managing their child's anxiety (measured by the PABUA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Behavioral: Psychoeducation for anxietyAll participants completed the intervention package. The intervention was made up of 3 online training videos lasted a total of 22 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary care giver of children aged 5-12 years
- The child has a long term health condition (LTHC)
Key exclusion criteria (4 listed)
- Carers of children with a learning disability or waiting for an assessment for a learning disability, not including ADHD or dyslexia. This does however include Autism.
- Participants must be over 18
- Access to their own electronic device
- Not have sufficient proficiency in spoken English
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 |
|---|---|---|
| Psychoeducation for anxietyThe intervention was made up of 3 videos, totalling 22 minutes. The videos incorporated psychoeducation on anxiety and Acceptance and Commitment Therapy (ACT) based skills for carers to consider using to support their child with anxiety. All material was based on children with long term health conditions. | Behavioural | Single Group |
Primary outcome
Structured Feedback Questionnaire
Time frame: Immediately post-intervention
Measure to assess the acceptability and feasibility of the training, for example assessing the consent process and format of the training. The measure uses a scale of strongly disagree (1) to strongly agree (5).
Follow-up Structured Feedback Questionnaire
Time frame: 2-week follow-up
Measure to assess barriers to engaging with the strategies since the training and reviewing usefulness of the strategies used. The measure uses a scale of strongly disagree (1) to strongly agree (5).
1 secondary outcome
Parent, Attitudes, Beliefs and Understanding about Anxiety (PABUA) (Wolk et al, 2016)
Time frame: Pre-intervention and 2-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Introduction video to the studyLink provided by the sponsor.
- Video 1 of the trainingLink provided by the sponsor.
- Video 2 of the trainingLink provided by the sponsor.
- Video 3 of the trainingLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the sensitive nature of the data and potential risk of identification due to the small sample size.
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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.
Kiki Mastroyannopoulou, Senior Fellow of HEA study chair
University of East Anglia (UEA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation for anxiety in people with Long-term Health Conditions, run by University of East Anglia 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 2 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: finished, as of the sponsor's last update on 18 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Structured Feedback Questionnaire (time frame: Immediately post-intervention). 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?
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 18 Jun 2026; AzTrials last refreshed its copy on 28 Oct 2026.