Clinical trial NCT05777161: A Trial of Parent-coached Exposure Therapy for Children With Anxiety Disorders and OCD
Official title: A Randomized-controlled Trial of Therapy for Children and Adolescents With Anxiety Disorders and Obsessive Compulsive Disorder (OCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Obsessive-Compulsive Disorder
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 162
Sex: ALL
Minimum age (years): 7
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in symptom severity per blinded independent evaluator
timeFrame: Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
measure: Treatment efficiency
timeFrame: post-treatment (approximately 14 weeks)
Secondary outcomes:
measure: Change in anxiety symptoms per blinded independent evaluator
timeFrame: Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
measure: Change in symptom severity per parent
timeFrame: Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
measure: Change in symptom severity per child
timeFrame: Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
Other outcomes:
measure: Change in functioning per parent
timeFrame: Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
measure: Change in functioning per child
timeFrame: Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Stephen Whiteside, PhD
role: PRINCIPAL_INVESTIGATOR
References: