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
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Change from Baseline in self-report anxiety levels of the parent and child participants at 5-week follow-up
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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.
结局指标
主要结局
Change from Baseline in self-report anxiety levels of the parent and child participants at 5-week follow-up
时间窗: 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
时间窗: 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.
次要结局
- 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 teenager's health-related quality of life(Baseline, 5-, 12-, and 24-week follow-ups)
- Change in parental caring burden level(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(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(Baseline, 12-, and 24-week follow-ups)
研究者
Dr Arnold Wong Yu Lok
Associate Professor
The Hong Kong Polytechnic University