Clinical trial NCT07024758: Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD
Official title: Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obsessive Compulsive Disorder (OCD)
Anxiety Disorder of Childhood or Adolescence
Social Anxiety Disorder of Childhood
Generalized Anxiety Disorder (GAD)
Separation Anxiety Disorder
Panic Disorder
Panic Attacks
Panic Disorder (With or Without Agoraphobia)
Phobia, Specific
Keywords: Obsessive-compulsive disorder
anxiety
cognitive-behavioral therapy
children
adolescents
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 174
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children (N=174) ages 7-17 will be randomized into one of two conditions.
Primary purpose: TREATMENT

Brief summary: Anxiety disorders in children and adolescents are common and confer significant disability. Cognitive behavioral therapy (CBT) is the recommended treatment for youth with anxiety, yet many families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. To combat these barriers, other treatment methods have been developed.

Previous research has shown that family-based, internet-delivered CBT (iCBT) for anxiety and OCD in youth has shown a significant reduction in anxiety symptoms. Parent-coached exposure therapy (PCET) focuses entirely on teaching parents and youth together how to address anxiety through the completion of in-session parent-coached exposures and assigning parent-coached exposure as homework in between sessions.

Although both iCBT and PCET show positive results in treating pediatric anxiety in comparison to standard-care CBT, little is known about the comparative efficacy of iCBT and PCET.

This research is being done to understand the comparative effectiveness of two different types of cognitive-behavioral therapy (CBT) for treating anxiety or OCD in youth.

Detailed description: Anxiety disorders in children and adolescents are common and confer significant disability. Without treatment, anxiety remains chronic and contributes to increased risk for later suicidality, mood, and substance use disorders. Cognitive behavioral therapy (CBT) is the recommended treatment for youth with anxiety, yet many families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. To combat these barriers, other treatment methods have been developed.

Low intensity telehealth delivery of services is a promising method to improve access to care for youth with anxiety and their families, given its reachability to a wider range of areas (e.g., rural/underserved) and its ability to minimize practical barriers (e.g., treatment could be delivered to the youth's home without need for travel), and reduce stigma (e.g., parents do not need to visit mental health clinics). Previous research has shown that family-based, internet-delivered CBT (iCBT) for anxiety and OCD in youth has shown a significant reduction in anxiety symptoms.

Parent-coached exposure therapy (PCET) focuses entirely on teaching parents and youth together how to address anxiety through the completion of in-session parent-coached exposures and assigning parent-coached exposure as homework in between sessions. PCET is designed to treat anxiety more effectively and efficiently, allowing for fewer sessions and greater symptom remission than standard-care CBT.

Although both iCBT and PCET show positive results in treating pediatric anxiety in comparison to standard-care CBT, little is known about the comparative efficacy of iCBT and PCET.

This research is being done to understand the comparative effectiveness of two different types of cognitive-behavioral therapy (CBT) for treating anxiety or OCD in youth.

Eligibility criteria: Inclusion Criteria:

* The child is between the ages of 7 to 17 years inclusive at enrollment.
* The child has clinically significant symptoms of anxiety and/or OCD, as indicated by a score of 12 or higher on the Pediatric Anxiety Rating Scale (PARS).
* The child is appropriate for anxiety-focused treatment (e.g., anxiety or OCD is the primary or co-primary problem as diagnosed using the DIAMOND-KID).
* One parent/guardian is able and willing to participate in assessment and treatment (e.g., has sufficient English fluency, the decisional capacity to participate, and can commit to treatment duration).
* The participating parent/guardian lives with their child at least 50% of the time per self-report.
* Both parent and child can read and understand English.
* The participant has an IQ above 69, based on the KBIT-2, another valid test or clinician judgement (e.g., a previous assessment conducted, and report shared with study team).
* Participants must be in the state of Texas for treatment sessions/assessments.

Exclusion Criteria:

* The child has a diagnosis of a lifetime psychotic disorder and/or conduct disorder.
* The child has significant, current and active suicidality/homicidality and/or self-injury requiring medical intervention.
* The child has limited verbal communication abilities (e.g., no independent verbal communication).
* The child is receiving concurrent psychotherapy with anxiety and/or OCD as the primary focus. They can pause ongoing therapy to enroll.
* The child has initiated new antidepressant medication within 12-weeks of assessment (4-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy.
* The child has changed psychotropic medication dosage within 4-weeks of assessment (2-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy.
* The child requires a higher level of care than can be provided through the study (e.g., significant, current suicidal ideation).

Primary outcomes:
measure: Change in clinician-rated child anxiety severity (PARS) throughout the past week.
timeFrame: baseline (before treatment or week 1), post-treatment (week 14), 1 month follow up (Week 18)
Secondary outcomes:
measure: Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) with Clinical Severity Ratings
timeFrame: baseline (before treatment or week 1), post-treatment (week 14), 1 month follow up (Week 18)
measure: Clinical Global Impression-Severity
timeFrame: baseline (before treatment or Week 1), during treatment (on average 14 weeks), post-treatment (Week 14), 1 month follow up (Week 18)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
citation: Whiteside SPH, Biggs BK, Geske JR, Gloe LM, Reneson-Feeder ST, Cunningham M, Dammann JE, Brennan E, Ong ML, Olsen MW, Hofschulte DR. Parent-coached exposure therapy versus cognitive behavior therapy for childhood anxiety disorders. J Anxiety Disord. 2024 Jun;104:102877. doi: 10.1016/j.janxdis.2024.102877. Epub 2024 May 18.
citation: Guzick AG, Schneider SC, Perozo Garcia AB, Kook M, Greenberg RL, Riddle D, McNeel M, Rodriguez-Barajas S, Yang M, Upshaw B, Storch EA. Development and pilot testing of internet-delivered, family-based cognitive behavioral therapy for anxiety and obsessive-compulsive disorders in autistic youth. J Obsessive Compuls Relat Disord. 2023 Apr;37:100789. doi: 10.1016/j.jocrd.2023.100789. Epub 2023 Feb 14.