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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-11

Study Completion Date

2022-08-30

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).

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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.

Conditions

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Anxiety Disorders Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessors were blind to condition. The integrity of the blind was evaluated

Study Groups

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Parent Coached Exposure Therapy-Individual (PCET-I) Group

Subjects will receive six to 14 weekly sessions of individual Parent Coached Exposure Therapy

Group Type EXPERIMENTAL

Parent Coached Exposure Therapy - Individualized

Intervention Type 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.

Traditional Cognitive Behavior Therapy (CBT) Group

Subjects will receive 6 to 14 weekly sessions of individual Cognitive Behavioral Therapy

Group Type ACTIVE_COMPARATOR

Cognitive Behavior Therapy

Intervention Type BEHAVIORAL

Subjects will work with a therapist using anxiety management strategies to address thoughts, feelings, and behaviors.

Parent Coached Exposure Therapy-5day Intensive (PCET-5day) Group (removed from study)

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

Group Type EXPERIMENTAL

Parent Coached Exposure Therapy - Group (removed from study)

Intervention Type 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.

Interventions

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Parent Coached Exposure Therapy - Individualized

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.

Intervention Type BEHAVIORAL

Cognitive Behavior Therapy

Subjects will work with a therapist using anxiety management strategies to address thoughts, feelings, and behaviors.

Intervention Type BEHAVIORAL

Parent Coached Exposure Therapy - Group (removed from study)

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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PCET-I CBT PCET

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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No