Autism Spectrum DisorderNCT07420478
TF-CBT for Autistic Youth Pilot Implementation - Open Pilot
A study testing Trauma-Focused Cognitive Behavioral Therapy, modified for autistic youth in people with Autism Spectrum Disorder and PTSD and Trauma-related Symptoms, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Compared to the general population, autistic youth are at increased risk for both exposure to potentially traumatic events and trauma-related symptoms following trauma exposure. Autistic people identify approaches to effectively addressing trauma as a top mental health research priority, yet providers in community… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Autism Spectrum Disorder, PTSD and Trauma-related Symptoms, Autism
- What is being tested?
- Trauma-Focused Cognitive Behavioral Therapy, modified for autistic youth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2026to 28 Feb 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Employed as a clinician at a participating Community Mental Health Center (CMHC; publicly-funded mental health program) for at least 6 months.
- Trained in TF-CBT.
- Has an eligible autistic youth on current caseload (see below).
- Between 6 and 18 years old (up to 17 years, 11 months).
- Current medical diagnosis of autism.
- Has a non-offending caregiver who is able to participate in treatment (i.e., caregiver who is not the perpetrator of the abuse/other trauma).
- Initiated outpatient psychotherapy services from participating therapist within enrolled CMHC.
- A moderate level of trauma-related distress as measured by the Child and Adolescent Trauma Screen-2 (CATS-2).
Who cannot join
- 1. Does not present with trauma-related distress (score falls within the "Normal" range as measured by the Child and Adolescent Trauma Screen-2 Self- and Parent-Report).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Kaitlyn Ahlers, PhD, 603-650-7075, kaitlyn.p.ahlers@hitchcock.org
Kaitlyn Ahlers, PhD
About this study
Official title: Implementation Science-Guided Pilot Study of Trauma-Focused Cognitive Behavioral Therapy for Autistic Youth in Community Mental Health Settings
Compared to the general population, autistic youth are at increased risk for both exposure to potentially traumatic events and trauma-related symptoms following trauma exposure. Autistic people identify approaches to effectively addressing trauma as a top mental health research priority, yet providers in community settings often report inadequate training in trauma treatment. The purpose of this study is to conduct an open pilot to evaluate the feasibility and acceptability of an evidence-based intervention for youth affected by trauma, Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), that has been modified for autistic youth served in Community Mental Health Centers.
- Conditions
- Autism Spectrum Disorder, PTSD and Trauma-related Symptoms, Autism, Trauma and Stressor Related Disorders, Mental Health Services
- Being tested
- Trauma-Focused Cognitive Behavioral Therapy, modified for autistic youth
- Keywords
- Autism, Trauma, PTSD, Mental health symptoms, TF-CBT, Implementation science, Trauma-Focused Cognitive Behavioral Therapy
- Medical subject headings
- Autism Spectrum Disorder, Stress Disorders, Post-Traumatic, Autistic Disorder, Trauma and Stressor Related Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Focused Cognitive Behavioral Therapy, modified for autistic youthBehavioural
Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is a cognitive-behavioral treatment to help children and adolescents recover after trauma. It is a structured, evidence-based treatment model that addresses posttraumatic stress disorder (PTSD) symptoms and other trauma-related symptoms. In TF-CBT, modified for autistic youth, clinicians will modify their use of TF-CBT for autistic youth. Clinicians will be trained in how to deliver TF-CBT to autistic youth.
| Study group | Role | What they receive |
|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy, modified for autistic youth | Experimental | Autistic youth will receive Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), modified for autistic youth, an evidence-based intervention for youth affected by trauma that has been modified for autistic youth. Enrolled clinicians will receive training in how to modify TF-CBT for autistic youth. Receives: Behavioral: Trauma-Focused Cognitive Behavioral Therapy, modified for autistic youth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Measure (AIM)
Parents/caregivers and therapists will complete the Acceptability of Intervention Measure (AIM), a widely used four-item measure that assesses the extent to which individuals believe an intervention is acceptable. Participants rate the intervention on a 5-point Likert scale, with higher scores indicating greater acceptability. Scores range from a minimum score of 4 to a maximum score of 20. This measure demonstrates good reliability and validity. Parents/caregivers and therapists trained in how to modify Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for autistic youth will complete the AIM at the 6-month (post-treatment) timepoint.
Measured: 6 months after starting implementation
Feasibility of Intervention Measure (FIM)
Therapists will complete the Feasibility of Intervention Measure (FIM), a widely used four-item measure that assesses the extent to which individuals believe an intervention is feasible. Participants rate the intervention on a 5-point Likert scale, with higher scores indicating greater feasibility. Scores range from a minimum score of 4 to a maximum score of 20. This measure demonstrates good reliability and validity. Therapists trained in how to modify Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for autistic youth will complete the FIM at the 6-month (post-treatment) timepoint.
Measured: 6 months after starting implementation
Intervention Appropriateness Measure (IAM)
Therapists will complete the Intervention Appropriateness Measure (IAM), a widely used four-item measure that assesses the extent to which individuals find an intervention to be appropriate. Participants rate the intervention on a 5-point Likert scale, with higher scores indicating greater appropriateness. Scores range from a minimum score of 4 to a maximum score of 20. This measure demonstrates good reliability and validity. Therapists trained in how to modify Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for autistic youth will complete the IAM at the 6-month (post-treatment) timepoint.
Measured: 6 months after starting implementation
Secondary outcomes (2)
Intervention Characteristics
Therapists will complete the Perceived Characteristics of Implementation Scale (PCIS), a 20-item measure that assesses providers' views on interventions. Participants rate their perceptions of the intervention on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores reflect more positive perceptions of the intervention. This measure has good reliability and construct validity.
Measured: 6 months after starting implementation
Intervention Usability
Therapists will complete the Intervention Usability Scale (IUS), a 10-item measure that is closely based on the well-validated System Usability Scale. Participants rate the intervention on a 1 to 5 scale and yield a total score from 0 to 100. High scores reflect greater usability. The IUS has good internal consistency.
Measured: 6 months after starting implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start5 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Kaitlyn P. Ahlers, Dartmouth-Hitchcock Medical Center
- Investigators
- Kaitlyn Ahlers, PhD, Principal investigator, Dartmouth Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420478
- Sponsor's protocol ID
- STUDY02002692_1
- Other IDs
- P20GM156710
- Status last verified
- May 2026
- First submitted
- 12 Feb 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Science-Guided Pilot Study of Trauma-Focused Cognitive Behavioral Therapy for Autistic Youth in Community Mental Health Settings
- ClinicalTrials.gov ID
- NCT07420478
- Acronym / sponsor ID
- STUDY02002692_1
- Conditions
- Autism Spectrum Disorder, PTSD and Trauma-related Symptoms, Autism, Trauma and Stressor Related Disorders, Mental Health Services
- Keywords
- Autism, Trauma, PTSD, Mental health symptoms, TF-CBT, Implementation science, Trauma-Focused Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 5 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 19 Feb 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.
Compared to the general population, autistic youth are at increased risk for both exposure to potentially traumatic events and trauma-related symptoms following trauma exposure. Autistic people identify approaches to effectively addressing trauma as a top mental health research priority, yet providers in community settings often report inadequate training in trauma treatment. The purpose of this study is to conduct an open pilot to evaluate the feasibility and acceptability of an evidence-based intervention for youth affected by trauma, Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), that has been modified for autistic youth served in Community Mental Health Centers.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy, modified for autistic youth | Experimental | Behavioral: Trauma-Focused Cognitive Behavioral Therapy, modified for autistic youthAutistic youth will receive Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), modified for autistic youth, an evidence-based intervention for youth affected by trauma that has been modified for autistic youth. Enrolled clinicians will receive training in how to modify TF-CBT for autistic youth. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Employed as a clinician at a participating Community Mental Health Center (CMHC; publicly-funded mental health program) for at least 6 months.
- Trained in TF-CBT.
- Has an eligible autistic youth on current caseload (see below).
- Between 6 and 18 years old (up to 17 years, 11 months).
- Current medical diagnosis of autism.
Key exclusion criteria (1 listed)
- 1. Does not present with trauma-related distress (score falls within the "Normal" range as measured by the Child and Adolescent Trauma Screen-2 Self- and Parent-Report).
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 |
|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy, modified for autistic youthTrauma-Focused Cognitive Behavioral Therapy (TF-CBT) is a cognitive-behavioral treatment to help children and adolescents recover after trauma. It is a structured, evidence-based treatment model that addresses posttraumatic stress disorder (PTSD) symptoms and other trauma-related symptoms. In TF-CBT, modified for autistic youth, clinicians will modify their use of TF-CBT for autistic youth. Clinicians will be trained in how to deliver TF-CBT to autistic youth. | Behavioural | Trauma-Focused Cognitive Behavioral Therapy, modified for autistic youth |
Primary outcome
Acceptability of Intervention Measure (AIM)
Time frame: 6 months after starting implementation
Parents/caregivers and therapists will complete the Acceptability of Intervention Measure (AIM), a widely used four-item measure that assesses the extent to which individuals believe an intervention is acceptable. Participants rate the intervention on a 5-point Likert scale, with higher scores indicating greater acceptability. Scores range from a minimum score of 4 to a maximum score of 20. This measure demonstrates good reliability and validity. Parents/caregivers and therapists trained in how to modify Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for autistic youth will complete the AIM at the 6-month (post-treatment) timepoint.
Feasibility of Intervention Measure (FIM)
Time frame: 6 months after starting implementation
Therapists will complete the Feasibility of Intervention Measure (FIM), a widely used four-item measure that assesses the extent to which individuals believe an intervention is feasible. Participants rate the intervention on a 5-point Likert scale, with higher scores indicating greater feasibility. Scores range from a minimum score of 4 to a maximum score of 20. This measure demonstrates good reliability and validity. Therapists trained in how to modify Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for autistic youth will complete the FIM at the 6-month (post-treatment) timepoint.
Intervention Appropriateness Measure (IAM)
Time frame: 6 months after starting implementation
Therapists will complete the Intervention Appropriateness Measure (IAM), a widely used four-item measure that assesses the extent to which individuals find an intervention to be appropriate. Participants rate the intervention on a 5-point Likert scale, with higher scores indicating greater appropriateness. Scores range from a minimum score of 4 to a maximum score of 20. This measure demonstrates good reliability and validity. Therapists trained in how to modify Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for autistic youth will complete the IAM at the 6-month (post-treatment) timepoint.
2 secondary outcomes
Intervention Characteristics
Time frame: 6 months after starting implementation
Intervention Usability
Time frame: 6 months after starting implementation
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 13 May 2026.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
Recruiting
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Autism Spectrum Disorder, Therapy
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
RecruitingPhase 2
TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS
Autism Disorder
Not yet recruitingObservational study
EEG As a Genetic Selection Lever in Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
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.
Kaitlyn Ahlers, PhD principal investigator
Dartmouth Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-Focused Cognitive Behavioral Therapy, modified for autistic youth in people with Autism Spectrum Disorder and PTSD and Trauma-related Symptoms, run by Dartmouth-Hitchcock Medical Center at 1 site 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 8 inclusion and 1 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 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Kaitlyn Ahlers, PhD (603-650-7075, kaitlyn.p.ahlers@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM) (time frame: 6 months after starting implementation). 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 13 May 2026.