Recruiting

Observational Study

Sponsor:

Florida International University

Code:

NCT07539519

Conditions

Autism

Mental Health Conditions

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

Interventions

Enhanced Psychotherapy

Treatment as Usual (TAU)

Study Details

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

Study ID

NCT07539519

Start date

Apr 9, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

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 Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Treatment as usual

Clients will continue to receive psychotherapy

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.

Interventions

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.

Treatment as Usual (TAU)

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

Primary outcome measure

  • Acceptability of Intervention Measure [ Time Frame: Baseline and 1 month ]
  • Feasibility of Intervention Measure [ Time Frame: Baseline and 1 month ]
  • Intervention Appropriateness Measure [ Time Frame: Baseline and 1 month ]

Central Contacts and Locations

Central contacts

Yael Dai, PhD

13053481034ydai@fiu.edu

Locations

Florida International University

Recruiting

Miami, Florida, United States, 33199

Contacts

Yael Dai, PhD

305-348-1034ydai@fiu.edu

More Information

Sponsor

Florida International University

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • mental health treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Florida International University on 2026-07-10.