NCT05919459 Effectiveness of Acceptance and Commitment Therapy Versus Active Controls in Improving Psychological Functions of Parents and Children With Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial
| NCT ID | NCT05919459 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Adolescent Idiopathic Scoliosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 336 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 336 participants in total. It began in 2023-09-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Systematic reviews revealed that Acceptance and Commitment Therapy (ACT) for parents had medium-to-large effect sizes in improving parental depression/anxiety (d \> 0.50), dysfunctional parenting styles (ds = 0.61-0.77), and small-to-large effect sizes in improving children's behavioral and emotional problems (ds = 0.25-0.84) in children/teenagers with various chronic diseases. A recent randomized controlled trial (RCT) showed that a web-based ACT program involving a coach providing semi-structured written feedback was significantly better than waitlist controls in improving the self-reported depression, anxiety, burnout, and psychological flexibility skills in parents of children/teenagers with chronic conditions (e.g., type 1 diabetes) up to 4 months post-treatment. The investigator's RCT also found that 4 weekly sessions of group-based ACT plus asthma education was significantly better than asthma education alone in improving parental psychological function (i.e., stress, anxiety, guilt, worries, sorrow, anger, and psychological flexibility), and participants' children's asthma symptoms at 6-month follow-up. The investigator's path analysis showed that ACT improved parental psychological flexibility, which mediated the decrease in parental distress and childhood asthma symptoms. These findings support that ACT for parents not only improves parental psychological flexibility and psychological controls, but also enhances social/emotional functioning of children/teenagers with different problems (e.g., chronic pain). Given the busy schedule of schoolchildren in Hong Kong and the promising results of ACT in improving the psychosocial well-being of both parents and teenagers, providing ACT to parents of teenagers with adolescent idiopathic scoliosis (AIS) may be a "killing two birds with one stone" solution to benefit both parents and teenagers. The current study will investigate this possibility.
Eligibility Criteria
Inclusion Criteria of 168 parent-child dyads: 1. the parent/guardian (henceforth "parents") aged between 25 and 60 years who is mainly responsible for taking care of a child with AIS (including the scoliosis clinic follow-ups) 2. the parent/guardian demonstrate at least mild anxiety (General Anxiety Disorder Scale scores \> 5) or mild depressive symptoms (Patient Health Questionnaire scores \> 5). 3. the parent/guardian live with the index child aged between 10 and 17 years. 4. the children have an orthopedist's diagnosis of AIS (Cobb angles of the major curve \> 10º). 5. the children are managed conservatively or waiting for surgery scheduled more than six months later. 6. both parents and children should reside in Hong Kong for at least another six months. 7. both parents and children should be able to read/understand Chinese, 8. both parents and children can be reachable via phone/email, and can access the Internet on their own computers, tablets, or smartphones. Exclusion Criteria: 1. parents and/or children with psychological disorders or behavioral problems (e.g., attention deficit hyperactivity disorder) that require regular psychological/psychiatric interventions; 2. children having undergone surgeries unrelated to AIS; or children with other types of scoliosis, or congenital diseases.
Contact & Investigator
Arnold Wong, PhD
PRINCIPAL INVESTIGATOR
The Hong Kong Polytechnic University
Frequently Asked Questions
Who can join the NCT05919459 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 60 Years, studying Adolescent Idiopathic Scoliosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05919459 currently recruiting?
Yes, NCT05919459 is actively recruiting participants. Contact the research team at arnold.wong@polyu.edu.hk for enrollment information.
Where is the NCT05919459 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT05919459 clinical trial?
NCT05919459 is sponsored by The Hong Kong Polytechnic University. The principal investigator is Arnold Wong, PhD at The Hong Kong Polytechnic University. The trial plans to enroll 336 participants.