A Pilot Trial of a Culturally Adapted Intervention to Prevent Self-harm in Young People With Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Intervention feasibility
研究概览
简要总结
The goal of this feasibility randomized controlled trial is to assess the feasibility and acceptability of Youth Culturally Adapted Manually Assisted brief psychological intervention (YCMAP) in young people with autism in Pakistan. In a rater-blind, 2-arm, multi-site, feasibility randomized controlled trial (RCT), participants will be randomized either to 1) YCMAP added to the Treatment as Usual (TAU) or 2) TAU alone. Participants in the Y-CMAP arm will receive 8-10 sessions delivered individually over 3 months (weekly for 1 month then fortnightly), lasting for 60 minutes. Assessments will be conducted at baseline and at 3 months.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 14-24 years
- •History of self-harm and/or possible suicidal behavior
- •Able to engage in assessment and intervention
- •Ability to provide informed consent
排除标准
- •Young people with autism with limited receptive and expressive language skills that would prevent engagement
- •With any chronic medical disorder or physical condition (including communicable diseases such as Tuberculosis) that would prevent participation in assessments and or intervention.
- •Not willing to participate.
研究组 & 干预措施
Y-CMAP + TAU
干预措施: Youth culturally adapted manual assisted psychological intervention (Y-CMAP) (Behavioral)
TAU alone
Treatment as usual (TAU) will include standard routine care that participants could potentially be receiving by their treating GP, or from autism centers, such as behavioral therapy, psychoeducation, occupational therapy, sports therapy, and art therapy. We will maintain a detailed record of each participant's routine care.
结局指标
主要结局
Intervention feasibility
时间窗: Baseline to 12 weeks
Data on recruitment and retention rates. The success criterion of feasibility will be to recruit \> 50% of eligible participants and retain 70%.
Intervention acceptability
时间窗: Baseline to 12 weeks
Acceptability will be assessed using data on attendance. The criterion for acceptability is the mean attendance rate of \>70% of sessions.
次要结局
- Suicide Attempt and Self-Harm(Baseline to 12 weeks)
- Beck Scale for Suicide Ideation(Baseline to 12 weeks)
- Card sort Task for Self-harm Behavior(Baseline to 12 weeks)
- Beck Hopelessness Scale(Baseline to 12 weeks)
- Autistic Depression Assessment Tool - Adult(Baseline to 12 weeks)
- Kessler Psychological Distress Scale(Baseline to 12 weeks)
- Euro-Qol-5 Dimensions scale(Baseline to 12 weeks)
- Autism Diagnostic Observation Schedule(Baseline)
- Childhood Autism Rating Scale-2(Baseline)