An interventional study of Enhanced Psychotherapy and Treatment as Usual (TAU) in Autism and Mental Health Conditions, sponsored by Florida International University. Recruiting at 2 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Florida International University · Not applicable, Interventional, and Treatment
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.
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's planned enrollment of 18 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Florida International University is the lead sponsor of 102 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The following describes Phase II (the clinical trial):
Inclusion Criteria for clients:
Exclusion criteria:
N/A
All therapists working at the community clinic at which this study takes place will be eligible to participate.
Clients will continue to receive psychotherapy
Behavioral: Treatment as Usual (TAU)
Clients will receive psychotherapy from therapists who have access to a toolkit that reviews ways to adapt evidence-based interventions for autistic clients.
Behavioral: Enhanced Psychotherapy
Clients randomized to the Enhanced Psychotherapy group will receive psychotherapy from therapists who have access to a toolkit that reviews strategies for tailoring evidence-based therapy to improve mental health treatment for autistic individuals.
Clients randomized to this condition will continue to receive psychotherapy in a community clinic
Acceptability of Intervention Measure
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.
Time frame: Baseline and 1 month
Feasibility of Intervention Measure
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.
Time frame: Baseline and 1 month
Intervention Appropriateness Measure
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.
Time frame: Baseline and 1 month
Autism Spectrum Knowledge Scale Professional Version - Revised
The Autism Spectrum Knowledge Scale Professional Version - Revised is a 25-item, multiple choice measure of autism knowledge designed specifically for use with professionals. The measure yields a raw score of items correct, with a range of 0 to 25. Higher scores indicate greater autism knowledge.
Time frame: Baseline and 1 month
Therapist Confidence Scale (TCS) - adapted for autism
The Therapist Confidence Scale measures therapists' confidence in working with autistic clients. It includes 13 items (scored 1-5), with higher scores indicating greater confidence. The average from the 13 items will range from 1 to 5, with higher scores indicating greater confidence.
Time frame: Baseline and 1 month
Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire measures clients' satisfaction with treatment. Eight items are rated on a 4-point Likert scale. Total scores range from 8-32, with higher scores indicating greater satisfaction.
Time frame: Baseline and 4 months
Goal Attainment Scaling
The Goal Attainment Scaling is a global-based assessment method used to measure individual progress towards personalized objectives. In Goal Attainment Scaling, specific, measurable goals are collaboratively set with clients, each goal is rated on a 5-point scale ranging from much less than expected (-2) to much more than expected (2). This approach allows for flexible, individualized outcome tracking that are important to autistic individual's quality of life, while still enabling standardized data collection across diverse clients.
Time frame: Baseline and 4 months
Clinical Global Impressions
The Clinical Global Impression is a commonly used clinician-rated scale to assess overall illness severity and improvement over time. Clinical Global Impression scores range from 1 ("normal") to 7 ("amongst the most severely ill patients), with higher scores indicating greater symptom severity. The clinical global impression change scores range from 1 (very much improved) to 7 (much worse).
Time frame: Baseline and 4 months
Plan to share: Undecided
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Florida International University