Family-Based Behavioral Therapy for Childhood Anxiety and OCD
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Baylor College of Medicine
Must not be taking: Antidepressants, Antipsychotics, Benzodiazepines, ADHD medications
Disqualifiers: Bipolar, Psychotic, Conduct, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications to join the trial?
You don't need to stop your current medications, but they must be stable for a certain period before joining the trial. If you're on an antidepressant, it should be stable for 12 weeks, and for other medications like antipsychotics or ADHD meds, it should be stable for 6 weeks. Any changes to your medication should have been made at least 4 weeks before joining.
What data supports the effectiveness of the treatment Family-Based Behavioral Therapy for Childhood Anxiety and OCD?
Research shows that family-based cognitive-behavioral therapy (CBT) is effective in treating pediatric obsessive-compulsive disorder (OCD) by involving family members to better manage symptoms. Studies indicate that family involvement in therapy can reduce OCD symptoms and improve family interactions, highlighting the importance of family-based approaches.
12345Is family-based behavioral therapy safe for children with anxiety and OCD?
Family-based behavioral therapy, including cognitive-behavioral therapy (CBT) and relaxation training, is generally considered safe for children with anxiety and OCD. Studies have focused on improving treatment outcomes by involving parents and addressing their behaviors, which can enhance the therapy's effectiveness without indicating any significant safety concerns.
13678How is the Family-Based Behavioral Therapy for Childhood Anxiety and OCD different from other treatments?
This treatment is unique because it involves the whole family in the therapy process, focusing on both cognitive-behavioral techniques and relaxation methods, which can help manage symptoms more effectively by addressing family dynamics and interactions that influence the child's condition.
12359Eligibility Criteria
This trial is for children aged 7-13 in Texas with significant anxiety or OCD, as indicated by specific test scores. They must have the ability to engage in CBT and live with a participating parent at least half the time. Children on stable medication may qualify, but those starting new treatments recently or changing dosages are excluded.Inclusion Criteria
The participating parent/guardian lives with their child at least 50% of the time per self-report
The child is appropriate for anxiety-focused treatment 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
+5 more
Exclusion Criteria
My child currently has severe thoughts of harming themselves or others, needing medical help.
My child is currently being treated for anxiety.
My mental health medications have been stable for the last 4 weeks.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive one of three interventions: Relaxation and Mentorship Training, SPACE, or iCBT over 12-14 weeks
12-14 weeks
4-6 video calls (30-45 minutes each), additional email support
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study compares family-based and internet-delivered cognitive behavioral therapy (CBT) against Relaxation and Mentorship Training (RMT). It aims to determine which method is more effective for treating anxiety and OCD in youth through telehealth services.
3Treatment groups
Experimental Treatment
Active Control
Group I: Parent Training Bibliotherapy (SPACE)Experimental Treatment1 Intervention
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.
Group II: Family-Based Internet-Based CBT Group (iCBT)Experimental Treatment1 Intervention
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.
Group III: Active ComparatorActive Control1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Baylor College of MedicineHouston, TX
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Who Is Running the Clinical Trial?
Baylor College of MedicineLead Sponsor
References
A preliminary study of cognitive-behavioral family-based treatment versus parent training for young children with obsessive-compulsive disorder. [2022]Cognitive-Behavioral Family-Based Treatment (CBFT) is the standard of care in young children with OCD. Developmental considerations, parent desires, and cost-effective advantages motivate research to explore the relative efficacy of parent-only interventions. The main goal in this study was to test the effectiveness and feasibility of a parent only intervention for OCD in young children, comparing, in a preliminary fashion the relative efficacy of reducing obsessive-compulsive symptoms through two treatment conditions: 1) an individual CBFT for early OCD involving both parents and children, and 2) the family component of the intervention involving only individual Parent Training (PT).
Family-Based Treatment of Pediatric Obsessive-Compulsive Disorder: Clinical Considerations and Application. [2018]Pediatric obsessive-compulsive disorder (OCD) can be effectively treated with family-based intervention by expanding and enhancing family members' behavioral repertoire to more effectively manage OCD symptoms and affected family interactions. This article provides an overview and practical understanding of the implementation of family-based treatment of pediatric OCD. Special attention is given to relevant contextual family processes that influence symptom presentation, current empirical support for family-based treatment, and the clinical application of family-based cognitive-behavioral therapy. Case vignettes illustrate important clinical considerations for providers.
Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents: protocol for a randomised clinical trial (the TECTO trial). [2022]Cognitive behavioural therapy (CBT) is the recommended first-line treatment for children and adolescents with obsessive-compulsive disorder (OCD), but evidence concerning treatment-specific benefits and harms compared with other interventions is limited. Furthermore, high risk-of-bias in most trials prevent firm conclusions regarding the efficacy of CBT. We investigate the benefits and harms of family-based CBT (FCBT) versus family-based psychoeducation and relaxation training (FPRT) in youth with OCD in a trial designed to reduce risk-of-bias.
Effect of Family and Patient Centered Empowerment Program on Depression, Anxiety and Stress in Patients with Obsessive-Compulsive Disorder and Their Caregivers' Burden. [2022]Considering the importance of family participation in patients' treatment and the positive effects of simultaneous patient and family education, this study was conducted to determine the effect of a family and patient-oriented empowerment program on depression, anxiety, and stress in patients with Obsessive-Compulsive Disorder (OCD) and their caregivers' burden.
Family involvement and treatment for young children with Obsessive-Compulsive Disorder: Randomized control study. [2022]The aim of this paper was to evaluate the diferential efficacy of cognitive behavioral family treatment in children under 8 years of age with Obsessive-Compulsive Disorder (OCD) in the reduction of obsessive-compulsive responses and secondary outcomes in three treatment conditions: (a) Treatment of parents and child, (b) Treatment of mother and child, and (c) Treatment of mother.
Overcoming barriers in cognitive-behavioral therapy for youth anxiety and obsessive-compulsive disorder: Addressing parent behaviors. [2021]Exposure-based cognitive-behavioral therapy (CBT) is a well-established treatment for anxiety disorders and obsessive-compulsive disorder (OCD) in youth. Although a majority of youth respond to CBT, a substantial portion remain symptomatic and/or experience a return of symptoms after completing a course of treatment. This highlights the need for further improvements to this evidence-based treatment. Given that parent behaviors can negatively influence treatment, addressing parental behaviors in CBT serves as a novel and promising treatment target to improve youth's therapeutic outcomes. The authors review three common parent behaviors that influence anxiety and treatment outcomes: family accommodation, parent anxious behaviors, and management of disruptive behaviors. The authors then discuss each behavior, its effect on anxiety/OCD and treatment, and how to address the behavior within the context of CBT. In doing so, therapeutic learning can be optimized to improve CBT outcomes for youth with anxiety disorders and/or OCD.
Early childhood OCD: preliminary findings from a family-based cognitive-behavioral approach. [2022]To examine the relative efficacy of family-based cognitive-behavioral therapy (CBT) versus family-based relaxation treatment (RT) for young children ages 5 to 8 years with obsessive-compulsive disorder (OCD).
Using Family-Based Exposure With Response Prevention to Treat Obsessive-Compulsive Disorder in Young Children: A Case Study. [2018]Cognitive-behavioral therapy (CBT) using exposure with response prevention (ERP) is the treatment of choice for obsessive-compulsive disorder (OCD); however, developmental modifications should be considered when treating young children. This article presents a case study illustrating family-based CBT using ERP with a 7-year-old boy. The delivery of ERP for this case was guided by 3 main principles: (a) family involvement with a focus on reducing family accommodation, (b) understanding the functional relation between the client's obsessions and compulsions, and (c) creating conditions to facilitate habituation during exposure. Outcomes for this case indicate significant improvement in functioning and OCD symptoms. Results highlight the importance of family involvement and the applicability of using a function-based habituation framework when delivering ERP to this unique population.
Effectiveness of cognitive behavior treatment for pediatric obsessive-compulsive disorder: acute outcomes from the Nordic Long-term OCD Treatment Study (NordLOTS). [2022]The purpose of this study was to examine the acute effectiveness of manualized exposure-based CBT with a family-based treatment, as an initial treatment for pediatric OCD delivered in regular community child and adolescents outpatient clinics. The report summarizes outcome of the first treatment step in the NordLOTS, which was conducted in Denmark, Sweden and Norway.