跳至主要内容
临床试验/NCT07539519
NCT07539519招募中不适用

A Transdiagnostic Toolkit to Improve Mental Health Treatment for Autistic Individuals

Florida International University2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年4月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
18
试验地点
2
主要终点
Acceptability of Intervention Measure

研究概览

简要总结

This pilot study is funded by the Organization for Autism Research (OAR). We are conducting a pilot study to improve mental health treatment for autistic individuals. First, we will conduct remote focus groups to identify barriers to mental health treatment and methods to improve treatment. Based on results, we will develop a prototype of a resource for therapists. This resource will be pilot tested in a community clinic.

详细描述

Research Design: During Phase I of the study, the investigators propose to conduct remote focus groups with autistic individuals (n=15) and with licensed therapists (n=15) in order to identify barriers to mental health treatment for autistic individuals, as well as ways to improve mental health treatment. Based on this information, the study team will develop a prototype of a therapist-facing toolkit that will include strategies for adapting evidence-based treatments when working with autistic individuals. In Phase II of the study, 6 therapists treating autistic clients (n=12) in a community clinic will be randomized to continue treatment as usual or to receive access to the toolkit. Study investigators will collect pilot data to explore whether the toolkit (1) improves therapist knowledge of autism and confidence treating mental health conditions in autistic people, (2) is acceptable to therapists, and (3) improves the acceptability and efficacy of mental health care for autistic adolescents.

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 (Participant)

盲法说明

In the clinical trial, the 12 autistic clients will be masked to their and their their therapist's condition. The 6 therapists will know whether they are randomized to the intervention or treatment as usual (TAU) group.

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The following describes Phase II (the clinical trial):
  • Inclusion Criteria for clients:
  • A confirmed diagnosis of autism
  • Between 13 and 17 years old
  • Fluent in English
  • Have a co-occurring mental health condition that is appropriate for treatment at the community clinic participating in the proposed study

排除标准

  • All therapists working at the community clinic at which this study takes place will be eligible to participate.

研究组 & 干预措施

Treatment as usual

Active Comparator

Clients will continue to receive psychotherapy

干预措施: Treatment as Usual (TAU) (Behavioral)

Enhanced Psychotherapy

Experimental

Clients will receive psychotherapy from therapists who have access to a toolkit that reviews ways to adapt evidence-based interventions for autistic clients.

干预措施: Enhanced Psychotherapy (Behavioral)

结局指标

主要结局

Acceptability of Intervention Measure

时间窗: Baseline and 1 month

The Acceptability of Intervention Measure includes four items rated on a five-point scale (1= "Completely Disagree"; 5 = "Completely Agree"). Items are averaged to produce an acceptability score. Higher scores indicate greater acceptability.

Feasibility of Intervention Measure

时间窗: Baseline and 1 month

The Feasibility of Intervention Measure includes four items rated on a five-point scale (1= "Completely Disagree"; 5 = "Completely Agree"). Items are averaged to produce a feasibility score. Higher scores indicate greater feasibility.

Intervention Appropriateness Measure

时间窗: Baseline and 1 month

The Intervention Appropriateness Measure includes four items rated on a five-point scale (1= "Completely Disagree"; 5 = "Completely Agree"). Items are averaged to produce an appropriateness score. Higher scores indicate greater appropriateness of the resource.

次要结局

  • Autism Spectrum Knowledge Scale Professional Version - Revised(Baseline and 1 month)
  • Therapist Confidence Scale (TCS) - adapted for autism(Baseline and 1 month)
  • Client Satisfaction Questionnaire(Baseline and 4 months)
  • Goal Attainment Scaling(Baseline and 4 months)
  • Clinical Global Impressions(Baseline and 4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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