Menu
Recruiting NCT07539519

A Toolkit to Improve Mental Health Treatment for Autistic Individuals

No phase Interventional Autism Mental Health Conditions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enhanced Psychotherapy, Treatment as Usual (TAU).
Who it may be relevant to
Registry conditions: Autism, Mental Health Conditions. Basic parameters: from 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Transdiagnostic Toolkit to Improve Mental Health Treatment for Autistic Individuals

Overview

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

  • 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.
  • Behavioral Treatment as Usual (TAU)
    Clients randomized to this condition will continue to receive psychotherapy in a community clinic

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Autism Spectrum Knowledge Scale Professional Version - Revised [Time frame: Baseline and 1 month]
  • Therapist Confidence Scale (TCS) - adapted for autism [Time frame: Baseline and 1 month]
  • Client Satisfaction Questionnaire [Time frame: Baseline and 4 months]
  • Goal Attainment Scaling [Time frame: Baseline and 4 months]
  • Clinical Global Impressions [Time frame: Baseline and 4 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Florida International University — Miami
  • Florida International University — Miami

Identifiers

NCT: NCT07539519 · AWD000000019067

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗