Effects of Acceptance and Commitment Therapy on Psychological Outcomes and Quality of Life of Parents of Children With Cerebral Palsy: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 主要终点
- Level of psychological flexibility
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate whether a group-based acceptance and commitment therapy (ACT) can improve the psychological outcomes and quality of life (QOL) of children with cerebral palsy. The main questions it aims to answer are:
- Does a group-based ACT improve the psychological flexibility of the participants?
- Does a group-based ACT improve the psychological distress, including depression, anxiety, and stress, of the participants?
- Does a group-based ACT improve the QOL of the participants?
Researchers will compare a group-based ACT to usual/standard care to determine whether ACT improves participants' psychological outcomes and QOL.
Participants will:
- Receive eight weekly, face-to-face, group-based ACT sessions, each lasting approximately 90 minutes.
- Receive home-based practices following each session.
- Receive a weekly phone call assessment to address any study-related concerns and provide reminders for the next appointment or assessment day.
- Complete the questionnaires at three times: baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents of children under 18 years with any type and severity of cerebral palsy
- •Able to communicate in Amharic, and
- •Able to provide written consent for participation
排除标准
- •Participants who have known psychological or psychiatric problems, and
- •Participants who are currently participating or have participated in another similar or related study within six months
研究组 & 干预措施
ACT intervention
干预措施: ACT intervention (Behavioral)
Usual/standard treatment
干预措施: Usual/standard control (Other)
结局指标
主要结局
Level of psychological flexibility
时间窗: Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
The psychological flexibility will be assessed using the 7-item Acceptance and Action Questionnaire-II (AAQ-II). Each item in the AAQ-II is scored on a scale of seven from 1(never true) to 7(always true). The total score is obtained by summing the scores of all items, and the higher the total score indicates greater psychological inflexibility.
Level of psychological distress
时间窗: Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
The psychological distress outcomes including, anxiety, depression, and stress will be assessed using the self-report 21-item anxiety, depression, and stress scale (DASS-21). Each of the subscales comprises 7 items and is scored on a four-point Likert scale ranging from 0(didn't apply at all to me) to 3(applied to me very much or most of the time), and the score is calculated by summing up the items in each subscale, and the final core is obtained by multiplying the core by two to make it comparable with the full scale (DASS-42). The higher the core indicates high distress symptoms.
次要结局
- Level of quality of life(Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).)
研究者
Kenneth N. K. Fong
Professor
The Hong Kong Polytechnic University