Adolescent Idiopathic ScoliosisNCT05919459
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
A study testing 5-week online synchronous ACT intervention and asynchronous online AIS education in people with Adolescent Idiopathic Scoliosis, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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 =… Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- 5-week online synchronous ACT intervention and asynchronous online AIS education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2023to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Arnold Wong, PhD, 2766 6741, arnold.wong@polyu.edu.hk
Arnold Wong, PhD
About this study
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.
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- 5-week online synchronous ACT intervention, asynchronous online AIS education
- Keywords
- Adolescent idiopathic scoliosis (AIS), Acceptance and commitment therapy (ACT), parental psychological flexibility, psychological function, Randomized Controlled Trial (RCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-week online synchronous ACT interventionBehavioural
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.
asynchronous online AIS educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Parents with ACT intervention | Experimental | 5-week online synchronous ACT intervention plus asynchronous online AIS education Receives: Behavioral: 5-week online synchronous ACT intervention; Behavioral: asynchronous online AIS education |
| Parents without ACT intervention | Other | 5-week interactive online AIS education Receives: Behavioral: asynchronous online AIS education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 5-week follow-ups
Secondary outcomes (8)
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.
Measured: Baseline, 5-, 12-, and 24-week follow-ups
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.
Measured: Baseline, 5-, 12-, and 24-week follow-ups
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.
Measured: Baseline, 5-, 12-, and 24-week follow-ups
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.
Measured: Baseline, 5-, 12-, and 24-week follow-ups
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.
Measured: Baseline, 5-, 12-, and 24-week follow-ups
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.
Measured: Baseline, 5-, 12-, and 24-week follow-ups
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.
Measured: Baseline,12-, and 24-week follow-ups
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.
Measured: Baseline, 12-, and 24-week follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Sep 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, Dr Arnold Wong Yu Lok, The Hong Kong Polytechnic University
- Investigators
- Arnold Wong, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919459
- Sponsor's protocol ID
- HSEARS20221121001
- Status last verified
- Feb 2024
- First submitted
- 30 May 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05919459
- Acronym / sponsor ID
- HSEARS20221121001
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent idiopathic scoliosis (AIS), Acceptance and commitment therapy (ACT), parental psychological flexibility, psychological function, Randomized Controlled Trial (RCT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents with ACT intervention | Experimental | Behavioral: 5-week online synchronous ACT intervention, Behavioral: asynchronous online AIS education5-week online synchronous ACT intervention plus asynchronous online AIS education |
| Parents without ACT intervention | Other | Behavioral: asynchronous online AIS education5-week interactive online AIS education |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-week online synchronous ACT interventionParents 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. | Behavioural | Parents with ACT intervention |
| asynchronous online AIS educationA 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. | Behavioural | Parents with ACT intervention, Parents without ACT intervention |
Primary outcome
Change from Baseline in self-report anxiety levels of the parent and child participants at 5-week follow-up
Time frame: Baseline, 5-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 5-week follow-up
Time frame: Baseline, 5-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.
8 secondary outcomes
Change in stress level of the parent-child dyads
Time frame: Baseline, 5-, 12-, and 24-week follow-ups
Change in parental psychological flexibility
Time frame: Baseline, 5-, 12-, and 24-week follow-ups
Change in family functioning for both parent and teen participants
Time frame: Baseline, 5-, 12-, and 24-week follow-ups
Change in dysfunctional parenting styles in parents
Time frame: Baseline, 5-, 12-, and 24-week follow-ups
Change in parental caring burden level
Time frame: Baseline, 5-, 12-, and 24-week follow-ups
Change in teenager's health-related quality of life
Time frame: Baseline, 5-, 12-, and 24-week follow-ups
Change from Baseline in self-report anxiety levels of the parent and child participants at 12-, and 24-week follow-ups
Time frame: Baseline,12-, and 24-week follow-ups
Change from Baseline in severity of depression symptoms in the parent and child participants at 12-, and 24-week follow-ups
Time frame: Baseline, 12-, and 24-week follow-ups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnold Wong, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-week online synchronous ACT intervention and asynchronous online AIS education in people with Adolescent Idiopathic Scoliosis, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnold Wong, PhD (27666741, arnold.wong@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in self-report anxiety levels of the parent and child participants at 5-week follow-up (time frame: Baseline, 5-week follow-ups). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.