Family Focused Treatment of Pediatric Obsessive Compulsive Disorder (PFIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2010 by University of California, Los Angeles
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01409642
First received: October 12, 2010
Last updated: August 3, 2011
Last verified: September 2010
  Purpose

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.


Condition Intervention
Obsessive-Compulsive Disorder
Behavioral: Individual Child CBT
Behavioral: Positive Family Interaction Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Feasibility Trial of Positive Family Interaction Therapy

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • OCD symptom severity on the Children's Yale Brown Obsessive Compulsive Scale (CYBOCS) [ Time Frame: Post-treatment (week 12) ] [ Designated as safety issue: No ]
    Treatment outcome will be evaluated based on decreases in total OCD symptom severity as measured by the CYBOCS.


Estimated Enrollment: 40
Study Start Date: January 2008
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Individual Child CBT
12 sessions of individual child-focused cognitive behavior therapy with a parent component
Behavioral: Individual Child CBT
12 sessions of individual child focused cognitive behavior therapy with a parent component
Other Name: child cognitive behavior therapy
Experimental: Positive Family Interaction Therapy
12 sessions of standard individual child CBT plus six sessions of positive family interaction therapy (PFIT)
Behavioral: Positive Family Interaction Therapy
Six sessions of family-focused treatment for childhood OCD administered as an adjunct to 12 sessions of child CBT
Other Name: Positive family interaction therapy
Behavioral: Positive Family Interaction Therapy
Positive Family Interaction Therapy (PFIT) is a 6-session treatment designed to be used as an adjunct to standard child CBT in cases where OCD is complicated by challenging family dynamics.
Other Name: PFIT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   9 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • Parents will be excluded based on the following criteria: (a) apparent parental psychiatric disturbance of sufficient severity to contraindicate study participation and/or (b) insufficient command of the English language. Parent psychiatric status will be screened using the Brief Symptom Inventory (BSI). This process will include review of available study assessment measures and further interview with the parent, if needed. Dr. Peris or another senior licensed clinician will meet with all parents deemed ineligible for study participation based on their psychiatric status to inform them of study ineligibility and reasons for exclusion and to provide at least two referrals will be provided for further care.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409642

Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Tara S Peris, Ph.D.    310-794-4347    tperis@mednet.ucla.edu   
Principal Investigator: Tara S Peris, Ph.D.         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Tara S Peris, Ph.D. University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Tara Peris, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01409642     History of Changes
Other Study ID Numbers: K23 MH085058
Study First Received: October 12, 2010
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on September 18, 2014