- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07420478
TF-CBT for Autistic Youth Pilot Implementation - Open Pilot
May 11, 2026 updated by: Kaitlyn P. Ahlers, Dartmouth-Hitchcock Medical Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kaitlyn Ahlers, PhD
- Phone Number: 603-650-7075
- Email: kaitlyn.p.ahlers@hitchcock.org
Study Locations
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Recruiting
- Dartmouth Hitchcock Medical Center
-
Contact:
- Kaitlyn Ahlers, PhD
- Phone Number: 603-650-7075
- Email: kaitlyn.p.ahlers@hitchcock.org
-
Principal Investigator:
- Kaitlyn Ahlers, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria for Therapists
- 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).
Inclusion Criteria for Child Participants
- 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).
Exclusion Criteria for Child Participants
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Trauma-Focused Cognitive Behavioral Therapy, modified for autistic youth
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months after starting implementation
|
|
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.
|
6 months after starting implementation
|
|
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.
|
6 months after starting implementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Characteristics
Time Frame: 6 months after starting implementation
|
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.
|
6 months after starting implementation
|
|
Intervention Usability
Time Frame: 6 months after starting implementation
|
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.
|
6 months after starting implementation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in symptoms via the Child Behavior Checklist (CBCL)
Time Frame: Baseline, 6 months
|
Parents/caregivers will complete the Child Behavior Checklist (CBCL), a broadband parent report measure of child problem behavior.
Caregivers rate 113 items assessing a range of child emotional and behavioral problems on a 3-point Likert scale from 0 (not true) to 2 (very true or often true).
This measure demonstrates good reliability and validity.
Raw scores from the internalizing and externalizing scales will be used in this study; higher scores reflect greater psychopathology.
|
Baseline, 6 months
|
|
Change in symptoms via the Youth Self Report (YSR)
Time Frame: Baseline, 6 months
|
Youth (11 and up) will complete the Youth Self-Report, a broadband self-report measure of child problem behavior.
Youth rate 113 items assessing a range of child emotional and behavioral problems on a 3-point Likert scale from 0 (not true) to 2 (very true or often true).
This measure demonstrates good reliability and validity.
Raw scores from the internalizing and externalizing scales will be used in this study; higher scores reflect greater psychopathology.
|
Baseline, 6 months
|
|
Change in trauma-related cognitions via the Child Post-Traumatic Cognitions Inventory (CPTCI) score
Time Frame: Baseline, 6 months
|
Youth will complete the Child Post-Traumatic Cognitions Inventory (CPTCI), a 25-item measure of trauma-related cognitions.
Youth rate their agreement with a list of statements on a 4-point Likert scale from "don't agree at all" to "agree a lot", and scores range from a minimum score of 25 to a maximum score of 100.
Higher scores reflect more trauma-related cognitions.
This measure has high internal consistency and test-retest reliability.
|
Baseline, 6 months
|
|
Change in child posttraumatic stress symptoms via the Child and Adolescent Trauma Screen 2 (CATS-2) Self-Report DSM-5 PTSD Total Score
Time Frame: Baseline, 6 months
|
The Child and Adolescent Trauma Screen 2 (CATS-2) Self-report includes 20 symptom items (assessed over the past month) that map onto the DSM-5 Posttraumatic Stress Disorder (PTSD) diagnostic criteria.
Symptom items are rated on a 4-point scale from 0 (never) to 4 (almost always) based on the frequency and severity of the reported symptom experienced, with higher scores indicating greater trauma-related symptoms.
Scores range from a minimum score of 0 to a maximum score of 60.
This measure demonstrates acceptable to excellent internal consistency.
Autistic youth will complete the CATS-2 at baseline and at the 6-month timepoints.
|
Baseline, 6 months
|
|
Change in child posttraumatic stress symptoms via the Child and Adolescent Trauma Screen 2 (CATS-2) Parent-Report DSM-5 PTSD Total Score
Time Frame: Baseline, 6 months
|
The Child and Adolescent Trauma Screen 2 (CATS-2) Parent-report includes 20 symptom items (assessed over the past month) that map onto the DSM-5 Posttraumatic Stress Disorder (PTSD) diagnostic criteria.
Symptom items are rated on a 4-point scale from 0 (never) to 4 (almost always) based on the frequency and severity of the reported symptom experienced, with higher scores indicating greater trauma-related symptoms.
Scores range from a minimum score of 0 to a maximum score of 60.
This measure demonstrates acceptable to excellent internal consistency.
Parents/caregivers will complete the CATS-2 at baseline and at the 6-month timepoints.
|
Baseline, 6 months
|
|
Change in behavioral avoidance via the Posttraumatic Avoidance Behavior Questionnaire (PABQ) score
Time Frame: Baseline, 6 months
|
Youth will complete the Posttraumatic Avoidance Behavior Questionnaire (PABQ), a 25-item measure of trauma-related avoidance behavior.
Youth rate the frequency with which they avoid experiences on a 4-point Likert scale from "(almost) never" to "(almost) always", and scores range from a minimum score of 25 to a maximum score of 100.
Higher scores reflect greater avoidance behavior.
This measure has good test-retest validity and convergent validity with PTSD symptom severity.
|
Baseline, 6 months
|
|
Change in emotion regulation via the Emotion Dysregulation Inventory (EDI) Parent-Report Reactivity score
Time Frame: Baseline, 6 months
|
Parents will complete the Emotion Dysregulation Inventory (EDI), a 30-item measure of emotion dysregulation, including reactivity and dysphoria.
Parents/caregivers rate the severity of their child's symptoms on a 5-point Likert scale from "not at all" to "very severe".
The 24-item EDI Reactivity Index is scored separately from the 6-item Dysphoria Index.
Scores on the Reactivity Index range from 0 to 96 and are converted to T-scores.
Higher scores reflect greater emotion dysregulation.
The EDI has demonstrated good validity and strong test-retest reliability in both autistic youth and general community and clinical samples.
|
Baseline, 6 months
|
|
Change in emotion regulation via the Emotion Dysregulation Inventory Self-Report (EDI-SR) Reactivity score
Time Frame: Baseline, 6 months
|
Youth (11 and up) will complete the Emotion Dysregulation Inventory Self-Report (EDI-SR), a 31-item measure of emotion dysregulation, including reactivity and dysphoria.
Youth rate the severity and/or frequency of their experiences on a 5-point Likert scale from "never happens" to "almost always happens or causes a serious problem".
Scores on the Reactivity Index range from 0 to 100 and are converted to T-scores.
Higher scores reflect greater emotion dysregulation.
The EDI-SR is based on the Emotion Dysregulation Inventory (EDI), which has demonstrated good validity and reliability.
|
Baseline, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kaitlyn Ahlers, PhD, Dartmouth Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
February 28, 2027
Study Registration Dates
First Submitted
February 12, 2026
First Submitted That Met QC Criteria
February 12, 2026
First Posted (Actual)
February 19, 2026
Study Record Updates
Last Update Posted (Actual)
May 13, 2026
Last Update Submitted That Met QC Criteria
May 11, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY02002692_1
- P20GM156710 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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