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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05777161
• Other study ID #: 20-008982
• Status: Completed
• Phase: N/A
• Start date: November 11, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: March 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Obsessive-Compulsive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Primary	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)
Primary	Treatment efficiency	Number of appointments attended	post-treatment (approximately 14 weeks)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Mayo Clinic Clinical Trials