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

Not Applicable
Completed
Conditions
Anxiety Disorders
Obsessive-Compulsive Disorder
Interventions
Behavioral: Cognitive Behavior Therapy
Behavioral: Parent Coached Exposure Therapy - Individualized
Behavioral: Parent Coached Exposure Therapy - Group (removed from study)
Registration Number
NCT05777161
Lead Sponsor
Mayo Clinic
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).

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
162
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Traditional Cognitive Behavior Therapy (CBT) GroupCognitive Behavior TherapySubjects will receive 6 to 14 weekly sessions of individual Cognitive Behavioral Therapy
Parent Coached Exposure Therapy-Individual (PCET-I) GroupParent Coached Exposure Therapy - IndividualizedSubjects will receive six to 14 weekly sessions of individual Parent Coached Exposure Therapy
Parent Coached Exposure Therapy-5day Intensive (PCET-5day) Group (removed from study)Parent Coached Exposure Therapy - 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
Primary Outcome Measures
NameTimeMethod
Change in symptom severity per blinded independent evaluatorBaseline, 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

Treatment efficiencypost-treatment (approximately 14 weeks)

Number of appointments attended

Secondary Outcome Measures
NameTimeMethod
Change in anxiety symptoms per blinded independent evaluatorBaseline, 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).

Change in symptom severity per parentBaseline, 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).

Change in symptom severity per childBaseline, 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).

Trial Locations

Locations (1)

Mayo Clinic Minnesota

🇺🇸

Rochester, Minnesota, United States

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