A Toolkit to Improve Mental Health Treatment for Autistic Individuals

A Transdiagnostic Toolkit to Improve Mental Health Treatment for Autistic Individuals

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism; Mental Health Conditions
• Intervention / Treatment: Behavioral: Treatment as Usual (TAU); Behavioral: Enhanced Psychotherapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yael Dai, PhD; Phone Number: 13053481034; Email: ydai@fiu.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33199
      • Florida International University
      • Contact: Yael Dai, PhD; Phone Number: 3053481034; Email: ydai@fiu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Exclusion criteria:

N/A

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment as usual; Clients will continue to receive psychotherapy	Behavioral: Treatment as Usual (TAU); Clients randomized to this condition will continue to receive psychotherapy in a community clinic
Experimental: Enhanced Psychotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline and 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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).	Baseline and 4 months

Collaborators and Investigators

• Sponsor: Florida International University
• Collaborators: Organization for Autism Research

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: mental health treatment
• Additional Relevant MeSH Terms: Autism Spectrum Disorder; Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Therapeutics
• Other Study ID Numbers: AWD000000019067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No