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The purpose of this study is to examine the effectiveness of parent coached exposure therapy (PCET) and standard cognitive behavioral therapy (CBT) in treating childhood anxiety disorders and obsessive compulsive disorder (OCD).
The purpose of this study is to examine the effectiveness of parent coached exposure therapy (PCET) through baseline comparisons, to compare effectiveness of individual PCET and individual standard cognitive behavioral therapy (CBT), to compare efficiency of individual PCET and individual standard CBT, to compare effectiveness of group intensive PCET, individual PCET, and individual standard CBT, and acceptability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parent Coached Exposure Therapy-Individual (PCET-I) Group | Experimental | Subjects will receive six to 14 weekly sessions of individual Parent Coached Exposure Therapy |
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| Traditional Cognitive Behavior Therapy (CBT) Group | Active Comparator | Subjects will receive 6 to 14 weekly sessions of individual Cognitive Behavioral Therapy |
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| Parent Coached Exposure Therapy-5day Intensive (PCET-5day) Group (removed from study) | Experimental | Subjects will receive 5 day (nine sessions) of group-based Parent Coached Exposure Therapy delivered within a span of five days (Monday through Friday), followed by 5 weeks of self-care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parent Coached Exposure Therapy - Individualized | Behavioral | Subject and parent begin by working with a therapist to create an individualized fear hierarchy consisting of situations and stimuli that produce anxiety for the child, gradually progressing from less anxiety to more anxiety. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptom severity per blinded independent evaluator | Measured by the Clinical Global Impression Scale (GCI-S) rating of severity of psychopathology ranging from 1 (not at all ill) to 7 (extremely ill), with a score of 1 or 2 reflecting no to minimal symptoms | Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks) |
| Treatment efficiency | Number of appointments attended | post-treatment (approximately 14 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety symptoms per blinded independent evaluator | Pediatric Anxiety Rating Scale consisting of 5 items rated from 0 (no symptoms) to 5 (most severe) summed for a total score ranging from 0 (no symptoms) to 25 (most severe). | Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in functioning per parent | Children's Sheehan Disability Scale (parent report) consisting of 5 items rated from 0 (not at all) to 10 (very, very much) summed to total score ranging from 0 (no interference) to 50 (severe interference). | Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Whiteside, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Current upon request. Determining how to make data more easily accessible.
Following publication of results. Indefinitely by request.
Approval of analysis plan
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2022 |
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Outcome assessors were blind to condition. The integrity of the blind was evaluated
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| Cognitive Behavior Therapy | Behavioral | Subjects will work with a therapist using anxiety management strategies to address thoughts, feelings, and behaviors. |
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| Parent Coached Exposure Therapy - Group (removed from study) | Behavioral | Subjects and parents will work in a group setting to receive exposure therapy consisting of situations and stimuli that produce anxiety for the child, gradually progressing from less anxiety to more anxiety. |
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| Change in symptom severity per parent |
Spence Children's Anxiety Scale parent-report consisting of 38 items rated from 0 (never) to 3 (always) summed to a total score of 0 (no symptoms) to 108 (most severe). |
| Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks) |
| Change in symptom severity per child | Spence Children's Anxiety Scale child-report consisting of 38 items rated from 0 (never) to 3 (always) summed to a total score of 0 (no symptoms) to 108 (most severe). | Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks) |
| Change in functioning per child |
Children's Sheehan Disability Scale (child report) consisting of 3 items rated from 0 (not at all) to 10 (very, very much) summed to total score ranging from 0 (no interference) to 30 (severe interference). |
| Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks) |
| Mar 8, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| 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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