Family Focused Treatment of Pediatric Obsessive Compulsive Disorder

NCT01409642 | Completed

• 1 other identifier: K23MH085058
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric obsessive compulsive disorder (OCD) is a chronic, impairing condition that accrues significant concurrent and long-term risk to affected youth (Piacentini et al. 2003; Pine et al. 1998). Although a host of pharmacological and psychosocial treatments have proliferated over the past decade (Barrett et al., 2008), many youth fail torespond to treatment and many who do respond continue to exhibit lingering symptoms and impairment. Thus, there is still much to be done by way of optimizing treatment outcomes for pediatric OCD. Increasingly, efforts to improve existing treatments have focused on aspects of the family environment that may affect treatment adherence and the maintenance of therapeutic gains. Such work suggests that parental accommodation and criticism are common characteristics of the home environment for both adults and children with OCD (Calvocoressi et al., 1999; Peris, Roblek, Langley, Chang, McCracken, \& Piacentini, 2008; Van Noppen et al., 1991) and that, in adult samples, these family features are associated with poorer treatment outcome and greater risk of relapse (Amir, Freshman, \& Foa, 2000; Chambless \& Steketee, 1999;Leonard et al., 1993). These family-level variables are logical targets for intervention, particularly among treatment refractory groups of youth with OCD. However, they often are unaddressed in extant interventions. The current study tests a novel intervention that specifically targets family accommodation and conflict in an effort to foster an environment that supports a graded exposure approach to treatment. The proposed treatment, Positive Family Interaction Therapy (PFIT), is composed of an innovative blend of techniques that address several potential barriers to treatment. First, the treatment is guided by the specific needs of youth with OCD and their families (e.g., accommodation, conflict). The first phase of the proposed study will involve an open case series in order to assess the utility of the PFIT protocol and feasibility of training other therapists and using the manual with a range of patient presentations. The second phase will involve a small controlled feasibility trial evaluating the extent to which recruitment, randomization, and implementation of the control condition are viable for further study. It is hypothesized that the PFIT treatment will be feasible to implement and will yield higher levels of patient satisfaction compared to treatment as usual.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• OCD symptom severity on the Children's Yale Brown Obsessive Compulsive Scale (CYBOCS)

  Treatment outcome will be evaluated based on decreases in total OCD symptom severity as measured by the CYBOCS.

  Post-treatment (week 12)

Study Arms (2)

Individual Child CBT

ACTIVE COMPARATOR

12 sessions of individual child-focused cognitive behavior therapy with a parent component

Behavioral: Individual Child CBT

Positive Family Interaction Therapy

EXPERIMENTAL

12 sessions of standard individual child CBT plus six sessions of positive family interaction therapy (PFIT)

Behavioral: Positive Family Interaction Therapy

Interventions

Individual Child CBT BEHAVIORAL

12 sessions of individual child focused cognitive behavior therapy with a parent component

Also known as: child cognitive behavior therapy

Individual Child CBT

Positive Family Interaction Therapy BEHAVIORAL

Six sessions of family-focused treatment for childhood OCD administered as an adjunct to 12 sessions of child CBT

Positive Family Interaction Therapy

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 9 to 17 years old, inclusive, at the point of consent.
• DSM-IV criteria for a primary diagnosis of OCD on the Anxiety Disorders Interview Schedule for DSM-IV (Silverman \& Albano, 1996).
• CYBOCS \>15
• Impaired family functioning as indicated by unhealthy FES conflict or PABS Blame scores (based on published FES clinic norms and distribution of PABS scores from our clinic population)
• Availability of primary caregivers to participate in the family-treatment module
• Informed parental consent and child assent.

You may not qualify if:

• Participants with the following DSM-IV psychiatric disorders will be excluded: Bipolar disorder, PTSD, substance abuse/dependence, conduct disorder, PDD, schizophrenia, or mental retardation. Youth with other comorbid disorders (e.g., anxiety, ADHD, ODD, TS) will be eligible as long as these disorders are secondary to OCD in terms of severity and impairment and do not require immediate initiation of treatment.
• Recent treatment with psychotropic medication within 6 weeks of study entry for fluoxetine, within 2 weeks for other SSRIs, and 4 weeks for neuroleptics.
• Child has failed a previous trial of CBT for anxiety within the previous 2 years judged adequate by at least 10 treatment sessions over a period of less than 1 year.
• Child has a major neurological disorder or a major medical illness that would interfere with participation in the study (e.g., frequent hospitalizations, frequent school absences).
• Child poses a significant risk for dangerousness to self or to others that makes participating inadvisable.
• Child and/or parent is non-English speaking (unable to complete measures, IE ratings, or treatment without the assistance of a dedicated translator).

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Peris TS, Rozenman MS, Sugar CA, McCracken JT, Piacentini J. Targeted Family Intervention for Complex Cases of Pediatric Obsessive-Compulsive Disorder: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2017 Dec;56(12):1034-1042.e1. doi: 10.1016/j.jaac.2017.10.008. Epub 2017 Oct 14.

  PMID: 29173737 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Tara S Peris, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: August 4, 2011
• Study Start: January 1, 2008
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: May 19, 2021

Record last verified: 2021-05

Locations

US (1)