- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07656220
An Acceptance and Commitment Therapy Psychoeducation Single Session Intervention on Childhood Anxiety for Carers of Children With a Long-Term Health Condition
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Norfolk
-
Norwich, Norfolk, United Kingdom, NR4 7UJ
- University of East Anglia (UEA)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primary care giver of children aged 5-12 years
- The child has a long term health condition (LTHC)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single Group
All participants completed the intervention package.
The intervention was made up of 3 online training videos lasted a total of 22 minutes.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Immediately post-intervention
|
|
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).
|
2-week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent, Attitudes, Beliefs and Understanding about Anxiety (PABUA) (Wolk et al, 2016)
Time Frame: Pre-intervention and 2-week follow-up
|
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).
|
Pre-intervention and 2-week follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Kiki Mastroyannopoulou, Senior Fellow of HEA, University of East Anglia (UEA)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Harriet Leader-White
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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