Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Location status: Recruiting
Location contact
Kaitlyn Ahlers, PhD
CONTACT
Kaitlyn Ahlers, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07420478
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.
Interested in participating?
Request Info6 year and older
All sexes
Interventional
Not applicable
Lebanon, New Hampshire, 03756, United States
Location status: Recruiting
Kaitlyn Ahlers, PhD
CONTACT
Kaitlyn Ahlers, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Therapists
Inclusion criteria
for Child Participants
Exclusion criteria
for Child Participants
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Dartmouth-Hitchcock Medical Center
Other
Implementation Science-Guided Pilot Study of Trauma-Focused Cognitive Behavioral Therapy for Autistic Youth in Community Mental Health Settings
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06081348
22Q11 Deletion, 22q11 Deletion Syndrome
Calgary, Alberta, Canada
View Trial DetailsNCT03866668
Autism, Autism Spectrum Disorder
Stanford, California, United States
View Trial DetailsNCT06362733
Autism, Autism Spectrum Disorder
Stanford, California, United States
View Trial DetailsNCT04899544
ASD, Autism
Stanford, California, United States
View Trial Details