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Active, not recruitingNCT05967468Updated Sep 2, 2026

Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder

An interventional study of Family Based, Internet-Based Cognitive Behavioral Therapy and Bibliotherapy, low therapist contact SPACE in Obsessive-Compulsive Disorder in Children, Anxiety Disorder of Childhood and Social Anxiety Disorder of Childhood, sponsored by Baylor College of Medicine. Active, not recruiting at 1 site in United States. Open to participants aged 7 Years to 13 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
7 Years to 13 Years
Sex
All
01

Study summary

Anxiety and obsessive-compulsive disorders are among the most common in children. Although cognitive behavioral therapy (CBT) is an effective and evidence-based treatment for such disorders, access to CBT is often limited. Family-based and internet-delivered therapy is one method to increase access to care. The purpose of this project is to evaluate the comparative efficacy and treatment mechanisms of two lower-intensity but effective treatments for families of children with anxiety or obsessive compulsive disorder (OCD) via telehealth compared to an adapted Relaxation and Mentorship Training (RMT) intervention involving breathing exercises with a therapist.

Read the detailed description

Cognitive-behavioral therapy (CBT) is an effective treatment for anxiety, yet access to CBT is limited for most families due to the cost, practicalities of attending in-person treatment sessions, and limited availability of trained therapists. Low-intensity telehealth delivery of services is a promising method to improve access to care for youth with anxiety and their families, givens 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 home without need for travel), and reduce stigma (e.g., parents do not need to visit mental health clinics). Additionally, parent-involved treatments for youth anxiety are effective and have the potential to reach more children and adolescents who refuse to see a therapist. However, these interventions have not been widely evaluated. The goal of this project is to evaluate the comparative efficacy and treatment mechanisms of two lower-intensity but effective treatments for families of children with anxiety or obsessive compulsive disorder (OCD) via telehealth compared to an adapted Relaxation and Mentorship Training (RMT) intervention involving breathing exercises with a therapist. This study involves two CBT-based intervention groups, both of which have demonstrated efficacy in prior work: 1) a parent-led, therapist-supported Internet based CBT intervention (iCBT) and 2) parent training paired with bibliotherapy intervention (SPACE).

02

Conditions studied

  • Obsessive-Compulsive Disorder in Children
  • Anxiety Disorder of Childhood
  • Social Anxiety Disorder of Childhood
  • Obsessive-Compulsive Disorder in Adolescence
  • Generalized Anxiety Disorder
  • Separation Anxiety
  • Panic Disorder
  • Panic Disorder With Agoraphobia
  • Panic Attacks

Keywords

  • obsessive-compulsive disorder
  • anxiety
  • cognitive-behavioral therapy
  • children
03

Who can participate

Ages eligible
7 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The child is between the ages of 7 to 13 years inclusion 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 is the primary or co-primary problem as diagnosed using the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-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 are able to read and understand English.
  • The child has the intellectual and communication skills to engage in CBT, as judged by an experienced supervising clinician.
  • Participants must be in the state of Texas for treatment sessions/assessments.

Exclusion criteria

Exclusion Criteria:

  • the child has a diagnosis of child lifetime bipolar disorder, drug or alcohol dependence, psychotic disorder, or conduct disorder.
  • the child has severe, current suicidal/homicidal ideation and/or self-injury requiring medical intervention (referrals will be made for appropriate clinical intervention).
  • the child is receiving concurrent therapy for anxiety.
  • New Treatments: Initiation of an antidepressant within 12 weeks before study enrollment OR 6 weeks for an antipsychotic, benzodiazepine, or attention deficit hyperactivity disorder (ADHD) medication before study enrollment. Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics, antipsychotic) within 4 weeks before study enrollment. Any medications must remain stable during treatment; downward adjustments due to side effects may be acceptable.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Family-Based Internet-Based CBT Group (iCBT)

    One third 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 (6 30-minute supportive videoconferencing via Zoom, 6 emails on alternating weeks). 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.

    Behavioral: Family Based, Internet-Based Cognitive Behavioral Therapy

  • Experimental
    Parent Training Bibliotherapy (SPACE)

    One third of participants will be randomized to the SPACE group. Families will receive 4 45-minute supportive video calls with a therapist over the course of 12-14 weeks. Participating families will receive a copy of the book 'Breaking Free of Child Anxiety and OCD' to use at home and in session with the therapist. During each of the video-conferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently.

    Behavioral: Bibliotherapy, low therapist contact SPACE

  • Active comparator
    Active Comparator

    One third of participants will be randomized to receive a Relaxation and Mentorship. This involves attending 4 45-minute sessions with a therapist over the course of 12-14 weeks. Topics covered include breathing slowly and deeply, coloring activities, and releasing muscle tension to reduce stress levels.

    Other: Relaxation and Mentorship

Interventions

  • BehavioralFamily Based, Internet-Based Cognitive Behavioral Therapy

    Family-based cognitive behavioral therapy employing internet-delivered modules and videos

  • BehavioralBibliotherapy, low therapist contact SPACE

    Parent-based bibliotherapy for treating anxiety disorders in youth

  • OtherRelaxation and Mentorship

    Relaxation based treatment

05

What researchers measure

Primary outcomes

  1. Change in clinician-rated child anxiety severity throughout the past week.

    Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 30.

    Time frame: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up

Secondary outcomes

  1. Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings

    Clinician-rated diagnostic interview that includes current anxiety disorders, depression, obsessive-compulsive disorder, and related disorders. Each diagnostic category is coded as present or absent based on symptom criteria and clinical severity ratings (CSRs), which indicate the level of clinical interference. CSRs are scored on a 0-8 scale (0 = not at all; 8 = very, very much). CSRs of 4 or above indicate the clinical levels.

    Time frame: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up

  2. Clinical Global Impression-Severity

    Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).

    Time frame: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up

06

Study locations

1 site
  • Baylor College of Medicine
    Houston, Texas 77030, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05967468
Lead sponsor
Baylor College of Medicine
Responsible party
Eric A Storch (Professor, Baylor College of Medicine) — Principal investigator
First posted
Aug 1, 2023
Start date
Sep 14, 2023
Primary completion
Dec 30, 2025
Completion
Dec 30, 2026 (estimated)
Last update
Sep 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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