Obsessive-Compulsive Disorder in ChildrenNCT05967468
Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder
A study testing Family Based, Internet-Based Cognitive Behavioral Therapy, Bibliotherapy, low therapist contact SPACE and Relaxation and Mentorship in people with Obsessive-Compulsive Disorder in Children and Anxiety Disorder of Childhood, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Obsessive-Compulsive Disorder in Children, Anxiety Disorder of Childhood, Social Anxiety Disorder of Childhood
- What is being tested?
- Family Based, Internet-Based Cognitive Behavioral Therapy, Bibliotherapy, low therapist contact SPACE and Relaxation and Mentorship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2023to 30 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Obsessive-Compulsive Disorder in Children, Anxiety Disorder of Childhood, Social Anxiety Disorder of Childhood, Obsessive-Compulsive Disorder in Adolescence, Generalized Anxiety Disorder, Separation Anxiety
- Being tested
- Family Based, Internet-Based Cognitive Behavioral Therapy, Bibliotherapy, low therapist contact SPACE, Relaxation and Mentorship
- Keywords
- obsessive-compulsive disorder, anxiety, cognitive-behavioral therapy, children
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety, Separation, Panic Disorder, Obsessive-Compulsive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Based, Internet-Based Cognitive Behavioral TherapyBehavioural
Family-based cognitive behavioral therapy employing internet-delivered modules and videos
Bibliotherapy, low therapist contact SPACEBehavioural
Parent-based bibliotherapy for treating anxiety disorders in youth
Relaxation and MentorshipOther
Relaxation based treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Relaxation and Mentorship |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up
Clinical Global Impression-Severity
Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).
Measured: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start14 Sep 2023
- Primary completion30 Dec 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive Disorder in ChildrenStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children (N=100), ages 7-13 will be randomized to one of three conditions
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric A Storch, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967468
- Sponsor's protocol ID
- H-53969
- Status last verified
- Aug 2026
- First submitted
- 12 Jul 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No