AutismNCT07539519
A Toolkit to Improve Mental Health Treatment for Autistic Individuals
A study testing Enhanced Psychotherapy and Treatment as Usual (TAU) in people with Autism and Mental Health Conditions, run by Florida International University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Autism, Mental Health Conditions
- What is being tested?
- Enhanced Psychotherapy and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Apr 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- N/A
- All therapists working at the community clinic at which this study takes place will be eligible to participate.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Florida International University
Miami, Florida, 33199
Yael Dai, PhD, 3053481034, ydai@fiu.edu
- Recruiting
Florida International University
Miami, Florida, 33199
Yael Dai, PhD, 305-348-1034, ydai@fiu.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism, Mental Health Conditions
- Being tested
- Enhanced Psychotherapy, Treatment as Usual (TAU)
- Keywords
- mental health treatment
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced PsychotherapyBehavioural
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)Behavioural
Clients randomized to this condition will continue to receive psychotherapy in a community clinic
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Clients will continue to receive psychotherapy Receives: 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. Receives: Behavioral: Enhanced Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 1 month
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start9 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- Organization for Autism Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539519
- Sponsor's protocol ID
- AWD000000019067
- Status last verified
- Jul 2026
- First submitted
- 3 Apr 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Transdiagnostic Toolkit to Improve Mental Health Treatment for Autistic Individuals
- ClinicalTrials.gov ID
- NCT07539519
- Acronym / sponsor ID
- AWD000000019067
- Conditions
- Autism, Mental Health Conditions
- Keywords
- mental health treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- Organization for Autism Research
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Behavioral: Treatment as Usual (TAU)Clients will continue to receive psychotherapy |
| Enhanced Psychotherapy | Experimental | Behavioral: Enhanced PsychotherapyClients will receive psychotherapy from therapists who have access to a toolkit that reviews ways to adapt evidence-based interventions for autistic clients. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- N/A
- All therapists working at the community clinic at which this study takes place will be eligible to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced PsychotherapyClients 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. | Behavioural | Enhanced Psychotherapy |
| Treatment as Usual (TAU)Clients randomized to this condition will continue to receive psychotherapy in a community clinic | Behavioural | Treatment as usual |
Primary outcome
Acceptability of Intervention Measure
Time frame: Baseline and 1 month
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.
Feasibility of Intervention Measure
Time frame: Baseline and 1 month
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.
Intervention Appropriateness Measure
Time frame: Baseline and 1 month
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Psychotherapy and Treatment as Usual (TAU) in people with Autism and Mental Health Conditions, run by Florida International University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yael Dai, PhD (13053481034, ydai@fiu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (time frame: Baseline and 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.