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

NCT05777161 | Completed

• 1 other identifier: 20-008982
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety Disorders; Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in anxiety symptoms per blinded independent evaluator

  Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)

• Change in symptom severity per parent

  Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)

• Change in symptom severity per child

  Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)

Other Outcomes (2)

• Change in functioning per parent

  Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)

• Change in functioning per child

  Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)

Study Arms (3)

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

EXPERIMENTAL

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

Behavioral: Parent Coached Exposure Therapy - Individualized

Traditional Cognitive Behavior Therapy (CBT) Group

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavior Therapy

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

EXPERIMENTAL

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)

Interventions

Parent Coached Exposure Therapy - Individualized 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.

Also known as: PCET-I

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

Cognitive Behavior Therapy BEHAVIORAL

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

Also known as: CBT

Traditional Cognitive Behavior Therapy (CBT) Group

Parent Coached Exposure Therapy - Group (removed from study) 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.

Also known as: PCET

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

Eligibility Criteria

• Age: 7 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Anxiety Disorders; Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Stephen Whiteside, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blind to condition. The integrity of the blind was evaluated
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 21, 2023
• Study Start: November 11, 2020
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Following publication of results. Indefinitely by request.
• Access Criteria: Approval of analysis plan

Locations

US (1)