Acceptance and Commitment Therapy for Parenting Children With Cerebral Palsy
Effects of Acceptance and Commitment Therapy on Psychological Outcomes and Quality of Life of Parents of Children With Cerebral Palsy: A Randomized Controlled Trial.
The goal of this randomized controlled trial is to evaluate whether a group-based acceptance and commitment therapy (ACT) can improve the psychological outcomes and quality of life (QOL) of children with cerebral palsy. The main questions it aims to answer are:
- Does a group-based ACT improve the psychological flexibility of the participants?
- Does a group-based ACT improve the psychological distress, including depression, anxiety, and stress, of the participants?
- Does a group-based ACT improve the QOL of the participants?
Researchers will compare a group-based ACT to usual/standard care to determine whether ACT improves participants' psychological outcomes and QOL.
Participants will:
- Receive eight weekly, face-to-face, group-based ACT sessions, each lasting approximately 90 minutes.
- Receive home-based practices following each session.
- Receive a weekly phone call assessment to address any study-related concerns and provide reminders for the next appointment or assessment day.
- Complete the questionnaires at three times: baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kenneth N.K Fong, PhD
- Phone Number: +852 2766 6716
- Email: rsnkfong@polyu.edu.hk
Study Contact Backup
- Name: Tenaw Gualu Melesse, PhD
- Phone Number: +852 5530 4750
- Email: tgmeles@polyu.edu.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parents of children under 18 years with any type and severity of cerebral palsy
- Able to communicate in Amharic, and
- Able to provide written consent for participation
Exclusion Criteria:
- Participants who have known psychological or psychiatric problems, and
- Participants who are currently participating or have participated in another similar or related study within six months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ACT intervention
|
Participants in the intervention group will receive an ACT that consists of eight sessions. Th introductions include an introduction, cognitive defusion, acceptance, being present, values, committed action, and noticing self/self-as context, and a summary session. An ACT-trained researcher will deliver weekly, face-to-face, group-based sessions, each lasting approximately 90 minutes, though durations may vary to accommodate group variations. Each group will consist of five to seven participants. The interventions will be delivered via various strategies, including psychoeducation, discussion, mindfulness exercises, and metaphors supplemented with with home practices. A research assistant will conduct a weekly phone call assessment to address any study-related concerns and provide reminders for the next appointment or assessment day. |
|
Other: Usual/standard treatment
|
Participants in the control group will receive the usual or standard care provided by the respective center.
To enhance participant retention in the study, a weekly phone call will be conducted by a research assistant, during which participants will be asked whether they have any concerns about the study and reminded of the next appointment or assessment day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of psychological flexibility
Time Frame: Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
|
The psychological flexibility will be assessed using the 7-item Acceptance and Action Questionnaire-II (AAQ-II).
Each item in the AAQ-II is scored on a scale of seven from 1(never true) to 7(always true).
The total score is obtained by summing the scores of all items, and the higher the total score indicates greater psychological inflexibility.
|
Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
|
|
Level of psychological distress
Time Frame: Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
|
The psychological distress outcomes including, anxiety, depression, and stress will be assessed using the self-report 21-item anxiety, depression, and stress scale (DASS-21). Each of the subscales comprises 7 items and is scored on a four-point Likert scale ranging from 0(didn't apply at all to me) to 3(applied to me very much or most of the time), and the score is calculated by summing up the items in each subscale, and the final core is obtained by multiplying the core by two to make it comparable with the full scale (DASS-42). The higher the core indicates high distress symptoms. |
Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of quality of life
Time Frame: Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
|
The quality of life will be evaluated by using the World Health Organization Quality of Life-BREF (WHOQOL-BREF). It comprises four domains: physical health, psychological, social relationships, and environment. Each item is scored on a five-point scale from 1 to 5, with varying response options across the domains, and some items need to be reversely scored. There are two items examined separately and will not be included in the score calculation. Domain scores are calculated by summing up the mean of all items in each domain and multiplying by four, and then the total score is transformed to a 0-100 scale to make the domains comparable. A higher the score indicates a higher QOL. |
Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20260707001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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