Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT07024758
Status
Recruiting
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Conditions

  • Anxiety Disorder of Childhood or Adolescence
  • Generalized Anxiety Disorder (GAD)
  • Obsessive Compulsive Disorder (OCD)
  • Panic Attacks
  • Panic Disorder
  • Panic Disorder (With or Without Agoraphobia)
  • Phobia, Specific
  • Separation Anxiety Disorder
  • Social Anxiety Disorder of Childhood

Eligibility Criteria

Sex
ALL
Age
7 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Parent Coached Exposure Therapy — BEHAVIORAL
    Parent-based cognitive behavioral therapy with guidance from a therapist
  • Family Based, Internet-Based Cognitive Behavioral Therapy — BEHAVIORAL
    Family-based cognitive behavioral therapy employing internet-delivered modules and videos

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
174 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Parent Coached Exposure Therapy (PCET)
    Parent Coached Exposure Therapy (PCET) consists of 12 weekly individual sessions that are attended by the therapist, child, and parent. Sessions will follow the cognitive behavioral therapy model of childhood anxiety disorders, wherein safety behaviors and avoidance reinforce anxiety, explains the rationale of exposure, and begins developing an exposure hierarchy with the family. Sessions will include psychoeducation, developing an exposure hierarchy, carrying out in-session exposures, and assigning exposures in between sessions.
  • Active Comparator: Family-Based Internet-Based CBT Group (iCBT)
    One half of participants will be randomized to receive iCBT. Each week of treatment, the parent will be encouraged to read the corresponding materials on the Baylor College of Medicine (BCM) webpage, complete accompanying worksheets, and guide their child through completing activities in the child-facing materials, with support from a therapist (7 45-minute supportive therapy sessions). One core aspect of treatment will be parents leading their child through graduated exposure. Exposures, a hallmark of CBT for anxiety, are used to gradually and repeatedly confront feared stimuli. For example, exposure therapy for a child fearful of dogs may begin with looking at pictures of dogs and standing across the park from a dog on a leash, to eventually petting a dog. All relevant information regarding parent-led exposures will be detailed in the treatment materials, and therapists will review with parents via email and/or video-conferencing sessions.

Primary Outcome Measure

Change in clinician-rated child anxiety severity (PARS) throughout the past week. [ Time Frame: baseline (before treatment or week 1), post-treatment (week 14), 1 month follow up (Week 18) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030
Eric Storch, Ph.D.
[email protected]
(713) 798-3579

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