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A Toolkit to Improve Mental Health Treatment for Autistic Individuals

A Transdiagnostic Toolkit to Improve Mental Health Treatment for Autistic Individuals

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07539519
Enrollment
18
Registered
2026-04-20
Start date
2026-04-09
Completion date
2027-12-01
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism, Mental Health Conditions

Keywords

mental health treatment

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.

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.

Interventions

BEHAVIORALEnhanced 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.

BEHAVIORALTreatment as Usual (TAU)

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

Sponsors

Florida International University
Lead SponsorOTHER
Organization for Autism Research
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of Intervention MeasureBaseline and 1 monthThe 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 MeasureBaseline and 1 monthThe 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 MeasureBaseline and 1 monthThe 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.

Secondary

MeasureTime frameDescription
Autism Spectrum Knowledge Scale Professional Version - RevisedBaseline and 1 monthThe 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.
Therapist Confidence Scale (TCS) - adapted for autismBaseline and 1 monthThe 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.
Client Satisfaction QuestionnaireBaseline and 4 monthsThe 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.
Goal Attainment ScalingBaseline and 4 monthsThe 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.
Clinical Global ImpressionsBaseline and 4 monthsThe 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).

Countries

United States

Contacts

CONTACTYael Dai, PhD
ydai@fiu.edu13053481034

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026