Anxiety Disorders, Obsessive-Compulsive Disorder
Conditions
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.
Interventions
BEHAVIORALParent 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.
BEHAVIORALCognitive Behavior Therapy
Subjects will work with a therapist using anxiety management strategies to address thoughts, feelings, and behaviors.
BEHAVIORALParent 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors were blind to condition. The integrity of the blind was evaluated
Eligibility
Sex/Gender
ALL
Age
7 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Treatment efficiency | post-treatment (approximately 14 weeks) | Number of appointments attended |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
Countries
United States
Outcome results
None listed