A Trial of Parent-coached Exposure Therapy for Children With Anxiety Disorders and OCD

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Randomized-controlled Trial of Therapy for Children and Adolescents With Anxiety Disorders and Obsessive Compulsive Disorder (OCD)

Conditions
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Anxiety Disorders, Obsessive-Compulsive Disorder

Intervention / Treatment
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* Behavioral: Parent Coached Exposure Therapy - Individualized
* Behavioral: Cognitive Behavior Therapy
* Behavioral: Parent Coached Exposure Therapy - Group (removed from study)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a DSM-5 anxiety disorder diagnosis, including generalized anxiety disorder, obsessive compulsive disorder, panic disorder, agoraphobia, separation anxiety disorder, social and specific phobias, as assessed on the relevant modules of the (MINI-Kids; (Sheehan et al., 2010) by study staff in the PADC. Be appropriate for the PADC standard outpatient therapy program, and be interested in starting outpatient therapy, Have the anxiety disorder as their primary diagnosis, If taking a selective serotonin reuptake inhibitor, SNRI, tricyclic, or antipsychotic medication, had no medication changes made at least 8 weeks prior to initiating participation in the study and agree to no changes during the 12 weeks of the study. Exclusion Criteria: History of and/or current psychosis, autism, bipolar disorder, or current suicidality, or eating disorder as assessed during the initial clinical interview and all available clinical information. Current positive diagnosis in the child's caregiver of mental retardation, psychosis, or other psychiatric disorders or conditions that would limit his/her ability to understand CBT and follow-through with treatment directives (based on clinical interview). Secondary diagnosis of oppositional defiant disorder or major depression of sufficient severity to prevent anxiety treatment. Severity of symptoms that warrant higher level of care (i.e. intensive, residential, IOP, inpatient) Family is unable to attend weekly sessions (i.e. geographical or scheduling barriers) History of good quality exposure or CBT.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parent Coached Exposure Therapy-Individual (PCET-I) Group<br>Subjects will receive six to 14 weekly sessions of individual Parent Coached Exposure Therapy | Behavioral: Parent Coached Exposure Therapy - Individualized<br>* 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.<br>* Other names: PCET-I;|
| Active Comparator: Traditional Cognitive Behavior Therapy (CBT) Group<br>Subjects will receive 6 to 14 weekly sessions of individual Cognitive Behavioral Therapy | Behavioral: Cognitive Behavior Therapy<br>* Subjects will work with a therapist using anxiety management strategies to address thoughts, feelings, and behaviors.<br>* Other names: CBT;|
| Experimental: Parent Coached Exposure Therapy-5day Intensive (PCET-5day) Group (removed from study)<br>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 | Behavioral: Parent Coached Exposure Therapy - Group (removed from study)<br>* 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.<br>* Other names: PCET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |