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

Primary Purpose

Anxiety Disorders, Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent Coached Exposure Therapy - Individualized
Cognitive Behavior Therapy
Parent Coached Exposure Therapy - Group (removed from study)
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

7 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

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

Traditional Cognitive Behavior Therapy (CBT) Group

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

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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
Treatment efficiency
Number of appointments attended

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
March 8, 2023
Last Updated
March 20, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05777161
Brief Title
A Trial of Parent-coached Exposure Therapy for Children With Anxiety Disorders and OCD
Official Title
A Randomized-controlled Trial of Therapy for Children and Adolescents With Anxiety Disorders and Obsessive Compulsive Disorder (OCD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessors were blind to condition. The integrity of the blind was evaluated
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent Coached Exposure Therapy-Individual (PCET-I) Group
Arm Type
Experimental
Arm Description
Subjects will receive six to 14 weekly sessions of individual Parent Coached Exposure Therapy
Arm Title
Traditional Cognitive Behavior Therapy (CBT) Group
Arm Type
Active Comparator
Arm Description
Subjects will receive 6 to 14 weekly sessions of individual Cognitive Behavioral Therapy
Arm Title
Parent Coached Exposure Therapy-5day Intensive (PCET-5day) Group (removed from study)
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Parent Coached Exposure Therapy - Individualized
Other Intervention Name(s)
PCET-I
Intervention Description
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
Intervention Name(s)
Cognitive Behavior Therapy
Other Intervention Name(s)
CBT
Intervention Description
Subjects will work with a therapist using anxiety management strategies to address thoughts, feelings, and behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Parent Coached Exposure Therapy - Group (removed from study)
Other Intervention Name(s)
PCET
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in symptom severity per blinded independent evaluator
Description
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
Time Frame
Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
Title
Treatment efficiency
Description
Number of appointments attended
Time Frame
post-treatment (approximately 14 weeks)
Secondary Outcome Measure Information:
Title
Change in anxiety symptoms per blinded independent evaluator
Description
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).
Time Frame
Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
Title
Change in symptom severity per parent
Description
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).
Time Frame
Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
Title
Change in symptom severity per child
Description
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).
Time Frame
Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
Other Pre-specified Outcome Measures:
Title
Change in functioning per parent
Description
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).
Time Frame
Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
Title
Change in functioning per child
Description
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).
Time Frame
Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Whiteside, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Current upon request. Determining how to make data more easily accessible.
IPD Sharing Time Frame
Following publication of results. Indefinitely by request.
IPD Sharing Access Criteria
Approval of analysis plan
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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

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