Family-Based Behavioral Therapy for Childhood Anxiety and OCD

Overseen By Eric Storch, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must not be taking: Antidepressants, Antipsychotics, Benzodiazepines, ADHD medications

Disqualifiers: Bipolar, Psychotic, Conduct, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12-14 weeks

100 Participants Needed

What You Need to Know Before You Apply

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.

Is 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. ^{1 2 3 4 5}

How 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. ^{1 4 6 7 8}

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. ^{1 4 6 8 9}

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Family Based
• Relaxation and Mentorship

Trial Overview 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.

How Is the Trial Designed?

Group I: Parent Training Bibliotherapy (SPACE) Experimental Treatment 1 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 Treatment 1 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 Comparator Active Control 1 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.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

A study involving 20 families with young children diagnosed with OCD found that both Cognitive-Behavioral Family-Based Treatment (CBFT) and Parent Training (PT) led to clinical improvements in obsessive-compulsive symptoms, indicating that parent-only interventions can be effective.

CBFT was more effective than PT in reducing externalizing problems, suggesting that while parent-only interventions are feasible, having the child present during treatment may provide additional benefits for certain symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary study of cognitive-behavioral family-based treatment versus parent training for young children with obsessive-compulsive disorder. Rosa-Alcázar, AI., Iniesta-Sepúlveda, M., Storch, EA., et al.[2022]

Family-based interventions are effective in treating pediatric obsessive-compulsive disorder (OCD) by improving how family members manage symptoms and interact with each other.

The article emphasizes the importance of understanding family dynamics and provides practical guidance on implementing family-based cognitive-behavioral therapy, supported by empirical evidence and case examples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-Based Treatment of Pediatric Obsessive-Compulsive Disorder: Clinical Considerations and Application. Anderson, LM., Freeman, JB., Franklin, ME., et al.[2018]

This study is a randomized clinical trial comparing family-based cognitive behavioral therapy (FCBT) to family-based psychoeducation and relaxation training (FPRT) in children and adolescents aged 8-17 with obsessive-compulsive disorder (OCD), aiming to include at least 128 participants to ensure robust results.

The trial is designed to minimize bias and enhance the reliability of findings by using blinding for assessors and randomizing therapists to deliver both interventions, allowing for a clearer understanding of the specific benefits and harms of FCBT compared to FPRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Pagsberg, AK., Uhre, C., Uhre, V., et al.[2022]

A family and patient-oriented empowerment program significantly reduced depression, anxiety, and stress in 50 OCD patients over eight training sessions, while the control group showed no significant changes in these areas.

The program also led to a notable decrease in caregiver burden, highlighting the benefits of involving both patients and their caregivers in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Family and Patient Centered Empowerment Program on Depression, Anxiety and Stress in Patients with Obsessive-Compulsive Disorder and Their Caregivers' Burden. Heidari, T., Mousavi, SM., Mousavinasab, SN., et al.[2022]

Cognitive-behavioral family treatment for children with OCD (ages 5.2-7.9) showed clinical improvements across all treatment conditions, indicating its overall efficacy in reducing OCD symptoms.

Involving more family members in the treatment, particularly the child, led to better outcomes, highlighting the importance of family dynamics in managing OCD effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family involvement and treatment for young children with Obsessive-Compulsive Disorder: Randomized control study. Rosa-Alcázar, Á., Rosa-Alcázar, AI., Olivares-Olivares, PJ., et al.[2022]

Exposure-based cognitive-behavioral therapy (CBT) is effective for treating anxiety disorders and OCD in youth, but many still experience symptoms after treatment, indicating a need for improvement in therapeutic approaches.

Addressing specific parental behaviors, such as family accommodation and anxious behaviors, can enhance the effectiveness of CBT, suggesting that involving parents in treatment may lead to better outcomes for youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming barriers in cognitive-behavioral therapy for youth anxiety and obsessive-compulsive disorder: Addressing parent behaviors. Chiappini, EA., Parrish, C., Reynolds, E., et al.[2021]

Family-based cognitive-behavioral therapy (CBT) was found to be effective for young children aged 5 to 8 with obsessive-compulsive disorder (OCD), showing a moderate treatment effect in the intent-to-treat sample and a large effect in those who completed the treatment.

In the study of 42 children, 50% of those receiving CBT achieved remission compared to only 20% in the family-based relaxation treatment (RT) group, highlighting CBT's superior efficacy in addressing OCD symptoms in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early childhood OCD: preliminary findings from a family-based cognitive-behavioral approach. Freeman, JB., Garcia, AM., Coyne, L., et al.[2022]

A case study of a 7-year-old boy with obsessive-compulsive disorder (OCD) demonstrated significant improvement in symptoms and functioning through family-based cognitive-behavioral therapy (CBT) using exposure with response prevention (ERP).

The treatment emphasized family involvement, understanding the relationship between obsessions and compulsions, and creating conditions for habituation, highlighting the effectiveness of these strategies in adapting ERP for young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Family-Based Exposure With Response Prevention to Treat Obsessive-Compulsive Disorder in Young Children: A Case Study. Herren, J., Freeman, J., Garcia, A.[2018]

In a study involving 269 children and adolescents aged 7-17 with OCD, 72.6% of participants who completed 14 weeks of manualized exposure-based CBT showed significant treatment response, as indicated by a CY-BOCS score of ≤15.

The treatment resulted in a mean symptom reduction of 52.9% and a high effect size of 1.58, demonstrating that this CBT approach is both effective and feasible for use in community mental health clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive behavior treatment for pediatric obsessive-compulsive disorder: acute outcomes from the Nordic Long-term OCD Treatment Study (NordLOTS). Torp, NC., Dahl, K., Skarphedinsson, G., et al.[2022]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

A preliminary study of cognitive-behavioral family-based treatment versus parent training for young children with obsessive-compulsive disorder. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Family-Based Treatment of Pediatric Obsessive-Compulsive Disorder: Clinical Considerations and Application. [2018]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. India pubmed.ncbi.nlm.nih.gov

Effect of Family and Patient Centered Empowerment Program on Depression, Anxiety and Stress in Patients with Obsessive-Compulsive Disorder and Their Caregivers' Burden. [2022]

5. Spain pubmed.ncbi.nlm.nih.gov

Family involvement and treatment for young children with Obsessive-Compulsive Disorder: Randomized control study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Overcoming barriers in cognitive-behavioral therapy for youth anxiety and obsessive-compulsive disorder: Addressing parent behaviors. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Early childhood OCD: preliminary findings from a family-based cognitive-behavioral approach. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Using Family-Based Exposure With Response Prevention to Treat Obsessive-Compulsive Disorder in Young Children: A Case Study. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive behavior treatment for pediatric obsessive-compulsive disorder: acute outcomes from the Nordic Long-term OCD Treatment Study (NordLOTS). [2022]