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| ID | Type | Description | Link |
|---|---|---|---|
| K01MH079945 | U.S. NIH Grant/Contract | View source | |
| DDTR B2-MBA |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will develop and test a treatment aimed at reducing anxiety in social situations for children and adolescents with autism spectrum disorders.
Autism spectrum disorders (ASDs) are developmental disorders with similar features, including problems communicating, problems interacting socially, and the presence of routines or repetitive behaviors. These disorders can have a range of severities. They include autistic disorder, Asperger's syndrome, and pervasive developmental disorder not otherwise specified (PDD-NOS). In addition to their core impairment in social functioning, children and adolescents with ASDs often have anxiety about social interactions, which compounds their difficulties and can limit the benefits of treatment. This study will develop and test a treatment program for developing social skills and reducing anxiety in children and adolescents with ASDs.
Participation in this study will last 12 to 14 weeks, with follow-up visits occurring 3 and 12 months after that. Participants will be randomly assigned to receive the treatment program either immediately or after being on a wait list. The treatment program will consist of 12 to 14 weekly individual therapy sessions that teach children and adolescents about ASDs, use cognitive-behavioral interventions to address problematic thinking and acting, deliver social skills instruction, and give opportunities to practice skills-including some practice outside the clinic in naturalistic settings. Every 2 weeks, starting at Week 4, children and adolescents will also attend group sessions to discuss strategies and practice social skills. Parents of the participants will be included at the end of each individual session for several minutes. After the participants assigned to immediate treatment complete the program, participants from the wait list will be offered the treatment.
Child and adolescent participants and their parents will complete assessments at baseline, midpoint in treatment, post-treatment (Week 12 or 14), and 3- and 12-month follow-ups. Participants assigned to the wait list condition will complete assessments only at baseline, before entering treatment (Week 12 or 14), and after completing treatment. Assessments will involve questionnaires about social and emotional functioning, interviews with study researchers, and surveys on satisfaction with the study. The child or adolescent's primary teacher will also complete questionnaires about the child.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) Program | Experimental | Participants will receive a treatment program involving CBT plus adjunctive group counseling and parent training. |
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| Wait list control | No Intervention | Participants will be placed on a 12-week wait list with no active treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) Program | Behavioral | 12 to 14 weekly sessions of individual CBT and parent training with 5 sessions of group counseling every other week |
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| Measure | Description | Time Frame |
|---|---|---|
| Child and Adolescent Symptom Inventory 20-Item Anxiety Subscale (CASI-20) | Measured at baseline, post-treatment, and 3-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan W White, PhD | Virginia Polytechnic Institute and State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Polytechnic Institute and State University | Blacksburg | Virginia | 24061 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 29, 2022 | |
| Reset | Sep 20, 2022 | |
| Release | Dec 15, 2023 |
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| Reset | Jan 9, 2024 |
| Release | Feb 23, 2024 |
| Reset | Mar 19, 2024 |
| Release | Mar 20, 2024 |
| Reset | Apr 16, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 29, 2022 | Sep 20, 2022 | |||
| Dec 15, 2023 | Jan 9, 2024 | |||
| Feb 23, 2024 | Mar 19, 2024 | |||
| Mar 20, 2024 | Apr 16, 2024 |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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