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Completed

NCT Number: NCT05777161

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

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Key information

Conditions

Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

7 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: PCET-I

Cognitive Behavior Therapy

Behavioral

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

Other names: CBT

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.

Other names: PCET

Primary outcomes

  1. Change in symptom severity per blinded independent evaluator

    Time frame: 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

    Time frame: post-treatment (approximately 14 weeks)

    Number of appointments attended

Secondary outcomes

  1. Change in anxiety symptoms per blinded independent evaluator

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Change in functioning per parent

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 21, 2023
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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