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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM156710 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria for Therapists
Inclusion Criteria for Child Participants
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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaitlyn Ahlers, PhD | Contact | 603-650-7075 | kaitlyn.p.ahlers@hitchcock.org |
| Name | Affiliation | Role |
|---|---|---|
| Kaitlyn Ahlers, PhD | Dartmouth Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
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| 6 months after starting implementation |
| 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. | 6 months after starting implementation |
| 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 | 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 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. | Baseline, 6 months |
| 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. | Baseline, 6 months |
| Change in trauma-related cognitions via the Child Post-Traumatic Cognitions Inventory (CPTCI) score | 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 emotion regulation via the Emotion Dysregulation Inventory (EDI) Parent-Report Reactivity score | 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 | 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 |
| Change in behavioral avoidance via the Posttraumatic Avoidance Behavior Questionnaire (PABQ) score | 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 |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D013313 | Stress Disorders, Post-Traumatic |
| D001321 | Autistic Disorder |
| D000068099 | Trauma and Stressor Related Disorders |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
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