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

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

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).

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder; Anxiety Disorders
• Intervention / Treatment: Behavioral: Parent Coached Exposure Therapy - Individualized; Behavioral: Cognitive Behavior Therapy; Behavioral: Parent Coached Exposure Therapy - Group (removed from study)

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.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parent Coached Exposure Therapy-Individual (PCET-I) Group; Subjects will receive six to 14 weekly sessions of individual Parent Coached Exposure Therapy	Behavioral: 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.; Other Names: PCET-I
Active Comparator: Traditional Cognitive Behavior Therapy (CBT) Group; Subjects will receive 6 to 14 weekly sessions of individual Cognitive Behavioral Therapy	Behavioral: Cognitive Behavior Therapy; Subjects will work with a therapist using anxiety management strategies to address thoughts, feelings, and behaviors.; Other Names: CBT
Experimental: 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	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.; Other Names: PCET

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Stephen Whiteside, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Anxiety Disorders
• Other Study ID Numbers: 20-008982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No