A Toolkit to Improve Mental Health Treatment for Autistic Individuals

NCT07539519 | Not Yet Recruiting

• 1 other identifier: AWD000000019067
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism; Mental Health Conditions

Keywords

mental health treatment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

Clients will continue to receive psychotherapy

Behavioral: Treatment as Usual (TAU)

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.

Behavioral: Enhanced Psychotherapy

Interventions

Enhanced Psychotherapy BEHAVIORAL

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.

Enhanced Psychotherapy

Treatment as Usual (TAU) BEHAVIORAL

Clients randomized to this condition will continue to receive psychotherapy in a community clinic

Treatment as usual

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Florida International University: lead
• Organization for Autism Research: collaborator

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Yael Dai, PhD

CONTACT

13053481034; ydai@fiu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)