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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT05777161
Collaborator
(none)
162
1
3
21.6
7.5

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Parent Coached Exposure Therapy - Individualized
  • Behavioral: Cognitive Behavior Therapy
  • Behavioral: Parent Coached Exposure Therapy - Group (removed from study)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
162 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcome assessors were blind to condition. The integrity of the blind was evaluated
Primary Purpose:
Treatment
Official Title:
A Randomized-controlled Trial of Therapy for Children and Adolescents With Anxiety Disorders and Obsessive Compulsive Disorder (OCD)
Actual Study Start Date :
Nov 11, 2020
Actual Primary Completion Date :
Aug 30, 2022
Actual Study Completion Date :
Aug 30, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Change in symptom severity per blinded independent evaluator [Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)]

      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

    2. Treatment efficiency [post-treatment (approximately 14 weeks)]

      Number of appointments attended

    Secondary Outcome Measures

    1. Change in anxiety symptoms per blinded independent evaluator [Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)]

      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).

    2. Change in symptom severity per parent [Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)]

      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).

    3. Change in symptom severity per child [Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)]

      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).

    Other Outcome Measures

    1. Change in functioning per parent [Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)]

      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).

    2. Change in functioning per child [Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Minnesota Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Stephen Whiteside, PhD, Mayo Clinic

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Stephen Whiteside, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05777161
    Other Study ID Numbers:
    • 20-008982
    First Posted:
    Mar 21, 2023
    Last Update Posted:
    Mar 22, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 22, 2023