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Recruiting NCT07420478

TF-CBT for Autistic Youth Pilot Implementation - Open Pilot

No phase Interventional Autism Spectrum Disorder PTSD and Trauma-related Symptoms Autism Trauma and Stressor Related Disorders

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: Trauma-Focused Cognitive Behavioral Therapy, modified for autistic youth.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder, PTSD and Trauma-related Symptoms, Autism, Trauma and Stressor Related Disorders. Basic parameters: from 6 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

Implementation Science-Guided Pilot Study of Trauma-Focused Cognitive Behavioral Therapy for Autistic Youth in Community Mental Health Settings

Overview

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.

Interventions

  • Behavioral Trauma-Focused Cognitive Behavioral Therapy, modified 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.

Primary outcome measures

  • Acceptability of Intervention Measure (AIM) [Time frame: 6 months after starting implementation]
  • Feasibility of Intervention Measure (FIM) [Time frame: 6 months after starting implementation]
  • Intervention Appropriateness Measure (IAM) [Time frame: 6 months after starting implementation]
Secondary outcome measures (2)
  • Intervention Characteristics [Time frame: 6 months after starting implementation]
  • Intervention Usability [Time frame: 6 months after starting implementation]

Eligibility criteria

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).

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Dartmouth Hitchcock Medical Center — Lebanon

Identifiers

NCT: NCT07420478 · STUDY02002692_1 · P20GM156710

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗