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

NCT05919459 | Recruiting

• 1 other identifier: HSEARS20221121001
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Adolescent idiopathic scoliosis (AIS); Acceptance and commitment therapy (ACT); parental psychological flexibility; psychological function; Randomized Controlled Trial (RCT)

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in self-report anxiety levels of the parent and child participants at 5-week follow-up

  The 7-item Chinese version of the Generalized Anxiety Disorder scale (GAD-7) will be used to evaluate the self-report anxiety levels of the parent and child participants. It evaluates the severity of seven core-anxiety items in the previous two weeks.

  Baseline, 5-week follow-ups

• Change from Baseline in severity of depression symptoms in the parent and child participants at 5-week follow-up

  The 9-item Chinese version of the Patient Health Questionnaire (PHQ-9) will be used to measure the severity of depression symptoms in the parent and child participants. The items evaluate whether the symptoms have affected an individual in the previous 2 weeks.

  Baseline, 5-week follow-ups

Secondary Outcomes (8)

• Change in stress level of the parent-child dyads

  Baseline, 5-, 12-, and 24-week follow-ups

• Change in parental psychological flexibility

  Baseline, 5-, 12-, and 24-week follow-ups

• Change in family functioning for both parent and teen participants

  Baseline, 5-, 12-, and 24-week follow-ups

• Change in dysfunctional parenting styles in parents

  Baseline, 5-, 12-, and 24-week follow-ups

• Change in parental caring burden level

  Baseline, 5-, 12-, and 24-week follow-ups

Study Arms (2)

Parents with ACT intervention

EXPERIMENTAL

5-week online synchronous ACT intervention plus asynchronous online AIS education

Behavioral: 5-week online synchronous ACT intervention; Behavioral: asynchronous online AIS education

Parents without ACT intervention

OTHER

5-week interactive online AIS education

Behavioral: asynchronous online AIS education

Interventions

5-week online synchronous ACT intervention BEHAVIORAL

Parents will meet a trained ACT counsellor to undergo five weekly sessions of ACT group training via Zoom. Specifically, each 120-minute synchronous videoconferencing session will involve the ACT counsellor and 6-8 parents.

Parents with ACT intervention

asynchronous online AIS education BEHAVIORAL

A healthcare educator with a background in nursing, physiotherapy, or occupational therapy will meet with parents in five weekly 120-minute interactive AIS-related education videoconferencing via Zoom. Specifically, each 120-minute synchronous videoconferencing session will involve the ACT counsellor and 6-8 parents.

Parents with ACT intervention; Parents without ACT intervention

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• the parent/guardian demonstrate at least mild anxiety (General Anxiety Disorder Scale scores \> 5) or mild depressive symptoms (Patient Health Questionnaire scores \> 5).
• the parent/guardian live with the index child aged between 10 and 17 years.
• the children have an orthopedist's diagnosis of AIS (Cobb angles of the major curve \> 10º).
• the children are managed conservatively or waiting for surgery scheduled more than six months later.
• both parents and children should reside in Hong Kong for at least another six months.
• both parents and children should be able to read/understand Chinese,
• both parents and children can be reachable via phone/email, and can access the Internet on their own computers, tablets, or smartphones.

You may not qualify if:

• parents and/or children with psychological disorders or behavioral problems (e.g., attention deficit hyperactivity disorder) that require regular psychological/psychiatric interventions;
• children having undergone surgeries unrelated to AIS; or children with other types of scoliosis, or congenital diseases.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• The University of Hong Kong: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

Study Officials

• Arnold Wong, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnold Wong, PhD

CONTACT

27666741; arnold.wong@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 26, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

HK (1)