TF-CBT for Autistic Youth Pilot Implementation - Open Pilot

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorDartmouth-Hitchcock Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

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

    Behavioral

    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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Trauma-Focused Cognitive Behavioral Therapy, modified for autistic youthExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months after starting implementation
2

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.

Time frame
6 months after starting implementation
3

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.

Time frame
6 months after starting implementation

Secondary outcomes

1

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.

Time frame
6 months after starting implementation
2

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.

Time frame
6 months after starting implementation

Other outcomes

1

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

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.

Time frame
Baseline, 6 months
2

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

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.

Time frame
Baseline, 6 months
3

Change in symptoms via the Child Behavior Checklist (CBCL)

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.

Time frame
Baseline, 6 months
4

Change in symptoms via the Youth Self Report (YSR)

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.

Time frame
Baseline, 6 months

Sponsors and contacts

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Dartmouth-Hitchcock Medical Center

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Collaborator