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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

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
5-week online synchronous ACT intervention
asynchronous online AIS education
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Adolescent idiopathic scoliosis (AIS), Acceptance and commitment therapy (ACT), parental psychological flexibility, psychological function, Randomized Controlled Trial (RCT)

Eligibility Criteria

10 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria of 168 parent-child dyads: 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. Exclusion Criteria: 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.

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Parents with ACT intervention

Parents without ACT intervention

Arm Description

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

5-week interactive online AIS education

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in stress level of the parent-child dyads
The Chinese version of the Perceived Stress Scale-10 (PSS-10) will be used to assess the stress level of the parent-child dyads. The PSS-10 has good validity and reliability.
Change in parental psychological flexibility
The 7-item Chinese version of the Acceptance and Action Questionnaire II (AAQ-II) will be used to measure parental psychological flexibility.
Change in family functioning for both parent and teen participants
The 36-item Chinese version of the Self-report Family Inventory (C-SFI) will be administered to both parent and teen participants to evaluate the family functioning. C-SFI discerns dysfunctional families from competent ones. It has demonstrated high internal consistency and temporal stability in local families over 1 year.
Change in dysfunctional parenting styles in parents
The 7-item Parenting Scale (PS-7) will be used to evaluate two dysfunctional parenting styles (over-reactivity [4 items] and laxness [3 items]) in parents. The factor score is the average score of the items in that factor. PS-7 has demonstrated good internal consistency and validity.
Change in parental caring burden level
The Chinese version of 22-item Zarit Caregiver Burden Inventory (ZCBI) will be used to assess the parental caring burden level in health, mental state, social life, and finance. The questionnaire has demonstrated good internal consistency.
Change in teenager's health-related quality of life
The Chinese version of the Scoliosis Research Society-22 (SRS-22r) questionnaire will be used to evaluate teenager's health-related quality of life (HRQOL). It comprises 22 questions in 5 domains: pain (5 items), self-image/appearance (5 items), mental health (5 items), function/activity (5 items), and satisfaction with management (2 items). Each item is graded on a 5-point scale ranging from 1 to 5. Higher scores indicate better HRQOL. The SRS-22r has demonstrated high reliability and validity in local adolescents.
Change from Baseline in self-report anxiety levels of the parent and child participants at 12-, and 24-week follow-ups
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.
Change from Baseline in severity of depression symptoms in the parent and child participants at 12-, and 24-week follow-ups
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.

Full Information

First Posted
May 30, 2023
Last Updated
June 16, 2023
Sponsor
The Hong Kong Polytechnic University
Collaborators
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05919459
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a single-blinded 2-arm RCT. A total of 168 parent-child dyads will be recruited consecutively from the scoliosis clinic in the Duchess of Kent Children's Hospital (DKCH). Eligible parents with the children will complete the baseline questionnaires and be randomized to either ACT or control group. Parents in the ACT group will be invited to join a 30-minute small private online course (SPOC) related to AIS. Parents in the ACT group will receive five weekly online ACT group-training sessions through Zoom. The controls will receive five weekly interactive online lectures/meetings through Zoom that will cover detailed topics related to AIS information and management. A research assistant, blinded to the group allocation, will use phone calls and emails to remind all participating parents and children to complete a set of online questionnaires identical to the baseline questionnaires at 5-, 12-, and 24-week follow-ups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
Adolescent idiopathic scoliosis (AIS), Acceptance and commitment therapy (ACT), parental psychological flexibility, psychological function, Randomized Controlled Trial (RCT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parents with ACT intervention
Arm Type
Experimental
Arm Description
5-week online synchronous ACT intervention plus asynchronous online AIS education
Arm Title
Parents without ACT intervention
Arm Type
Other
Arm Description
5-week interactive online AIS education
Intervention Type
Behavioral
Intervention Name(s)
5-week online synchronous ACT intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
asynchronous online AIS education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in self-report anxiety levels of the parent and child participants at 5-week follow-up
Description
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.
Time Frame
Baseline, 5-week follow-ups
Title
Change from Baseline in severity of depression symptoms in the parent and child participants at 5-week follow-up
Description
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.
Time Frame
Baseline, 5-week follow-ups
Secondary Outcome Measure Information:
Title
Change in stress level of the parent-child dyads
Description
The Chinese version of the Perceived Stress Scale-10 (PSS-10) will be used to assess the stress level of the parent-child dyads. The PSS-10 has good validity and reliability.
Time Frame
Baseline, 5-, 12-, and 24-week follow-ups
Title
Change in parental psychological flexibility
Description
The 7-item Chinese version of the Acceptance and Action Questionnaire II (AAQ-II) will be used to measure parental psychological flexibility.
Time Frame
Baseline, 5-, 12-, and 24-week follow-ups
Title
Change in family functioning for both parent and teen participants
Description
The 36-item Chinese version of the Self-report Family Inventory (C-SFI) will be administered to both parent and teen participants to evaluate the family functioning. C-SFI discerns dysfunctional families from competent ones. It has demonstrated high internal consistency and temporal stability in local families over 1 year.
Time Frame
Baseline, 5-, 12-, and 24-week follow-ups
Title
Change in dysfunctional parenting styles in parents
Description
The 7-item Parenting Scale (PS-7) will be used to evaluate two dysfunctional parenting styles (over-reactivity [4 items] and laxness [3 items]) in parents. The factor score is the average score of the items in that factor. PS-7 has demonstrated good internal consistency and validity.
Time Frame
Baseline, 5-, 12-, and 24-week follow-ups
Title
Change in parental caring burden level
Description
The Chinese version of 22-item Zarit Caregiver Burden Inventory (ZCBI) will be used to assess the parental caring burden level in health, mental state, social life, and finance. The questionnaire has demonstrated good internal consistency.
Time Frame
Baseline, 5-, 12-, and 24-week follow-ups
Title
Change in teenager's health-related quality of life
Description
The Chinese version of the Scoliosis Research Society-22 (SRS-22r) questionnaire will be used to evaluate teenager's health-related quality of life (HRQOL). It comprises 22 questions in 5 domains: pain (5 items), self-image/appearance (5 items), mental health (5 items), function/activity (5 items), and satisfaction with management (2 items). Each item is graded on a 5-point scale ranging from 1 to 5. Higher scores indicate better HRQOL. The SRS-22r has demonstrated high reliability and validity in local adolescents.
Time Frame
Baseline, 5-, 12-, and 24-week follow-ups
Title
Change from Baseline in self-report anxiety levels of the parent and child participants at 12-, and 24-week follow-ups
Description
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.
Time Frame
Baseline,12-, and 24-week follow-ups
Title
Change from Baseline in severity of depression symptoms in the parent and child participants at 12-, and 24-week follow-ups
Description
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.
Time Frame
Baseline, 12-, and 24-week follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria of 168 parent-child dyads: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnold Wong, PhD
Phone
27666741
Email
arnold.wong@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnold Wong, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Learn more about this trial

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

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