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

NCT05967468 | Active Not Recruiting

• 1 other identifier: H-53969
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety Disorder of Childhood; Obsessive-Compulsive Disorder in Children; 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

Outcome Measures

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.

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

Secondary Outcomes (2)

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

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

• Clinical Global Impression-Severity

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

Study Arms (3)

Family-Based Internet-Based CBT Group (iCBT)

EXPERIMENTAL

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

Parent Training Bibliotherapy (SPACE)

EXPERIMENTAL

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

Relaxation and Mentorship OTHER

Relaxation based treatment

Active Comparator

Family Based, Internet-Based Cognitive Behavioral Therapy BEHAVIORAL

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

Family-Based Internet-Based CBT Group (iCBT)

Bibliotherapy, low therapist contact SPACE BEHAVIORAL

Parent-based bibliotherapy for treating anxiety disorders in youth

Parent Training Bibliotherapy (SPACE)

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety, Separation; Panic Disorder; Obsessive-Compulsive Disorder; Anxiety Disorders

Interventions

Bibliotherapy

Condition Hierarchy (Ancestors)

Mental Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor is blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Children (N=100), ages 7-13 will be randomized to one of three conditions

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 1, 2023
• Study Start: September 14, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)