NCT07420478

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
May 2026Feb 2027

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 5, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

February 12, 2026

Last Update Submit

May 11, 2026

Conditions

Keywords

AutismTraumaPTSDMental health symptomsTF-CBTImplementation scienceTrauma-Focused Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    6 months after starting implementation

Secondary Outcomes (2)

  • Intervention Characteristics

    6 months after starting implementation

  • Intervention Usability

    6 months after starting implementation

Other Outcomes (8)

  • Change in child posttraumatic stress symptoms via the Child and Adolescent Trauma Screen 2 (CATS-2) Self-Report DSM-5 PTSD Total Score

    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

    Baseline, 6 months

  • Change in symptoms via the Child Behavior Checklist (CBCL)

    Baseline, 6 months

  • +5 more other outcomes

Study Arms (1)

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.

Behavioral: Trauma-Focused Cognitive Behavioral Therapy, modified for autistic youth

Interventions

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.

Trauma-Focused Cognitive Behavioral Therapy, modified for autistic youth

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • \. 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum DisorderStress Disorders, Post-TraumaticAutistic DisorderTrauma and Stressor Related DisordersWounds and Injuries

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersStress Disorders, Traumatic

Study Officials

  • Kaitlyn Ahlers, PhD

    Dartmouth Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 19, 2026

Study Start

May 5, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations