Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01409642 |
| Other study ID # |
K23MH085058 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2008 |
| Est. completion date |
December 2016 |
Study information
| Verified date |
May 2021 |
| Source |
University of California, Los Angeles |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Pediatric Obsessive Compulsive Disorder (OCD) is among the most common disorders of
childhood, affecting between 1 and 3% of the youth population. The disorder is associated
with substantial impairment in academic, social, and family functioning, and it carries a
host of risks as youth age into adulthood. Cognitive behavioral therapy (CBT) has emerged as
the treatment of choice for pediatric OCD, with typical treatment protocols involving
exposure to feared stimuli, identification and evaluation of maladaptive beliefs, relaxation
training, and behavioral rewards. Although these techniques have produced favorable results,
one third of youth with OCD do not demonstrate significant response to treatment and many of
those who do respond continue to evidence some degree of symptoms and impairment.
Efforts to improve therapy outcomes for youth with OCD increasingly have attempted to augment
individual CBT with greater family involvement. These programs typically involve
psychoeducation about OCD as well as general behavioral strategies for enhancing adherence to
treatment. Although current family-focused treatments vary with regard to the nature and
extent of parent involvement, to date, the incremental benefit of adding a family treatment
component to traditional individual treatment remains unclear. Indeed, there does not appear
to be a relation between the degree of family involvement and degree of treatment response,
and current family treatments do not appear to affect change in family beliefs or behaviors.
This picture suggests that either family involvement does not contribute to significant
improvement in child outcomes or that current treatments may not be sufficiently focused on
features of the home environment that are relevant for shaping and maintaining OCD symptoms.
Building from theoretical literature which identifies familial blame and accommodation as key
characteristics that are important for course and outcome in OCD, we have developed a novel
family intervention for use in treating pediatric OCD. Using techniques that are well
established, Positive-Family Interaction Therapy (P-FIT) attempts to reduce family blame,
accommodation, and conflict and to enhance family cohesion in high stress, high conflict
families.
The goals of this study are to investigate a manualized P-FIT program for youth with OCD
first with a small open trial of up to ten families to investigate the feasibility and
tolerability of the treatment and then with a randomized trial (the main study) to assess its
incremental efficacy over usual care (i.e., individual cognitive behavioral therapy). For the
initial pilot stage, up to four children between the ages of 9-17 will be treated with P-FIT
through the UCLA Child OCD, Anxiety, and Tic Disorders Program after completing a diagnostic
evaluation to confirm eligibility. During this pilot study, procedures and materials for the
manual will be refined and finalized for the controlled trial. The treatment will consist of
12 sessions of standard cognitive behavioral therapy that is augmented with a novel 6-session
family focused treatment module. Assessments involving interviews, questionnaires, and
several short tasks will be conducted at the beginning, midpoint and end of the treatment. We
will also follow up with families 3 months following treatment in order to assess durability
of any treatment gains. Study staff will meet weekly to discuss each open trial therapy
session, including the feasibility, efficacy, and acceptability of the treatment manual, and
make adjustments as needed. Once this group reaches consensus regarding the suitability of
the manual, recruitment into the open trial will end and subsequent eligible families will be
invited to participate in the randomized controlled trial (the main study).
Over the course of the main study, 40 youngsters will be randomized to receive either
individual child-centered cognitive behavioral therapy (ICBT) or the P-FIT intervention (ICBT
+ 6 sessions of family treatment). All subjects regardless of response status will be
evaluated at all scheduled assessment points. In addition to comprehensive parent, child, and
clinician reports, the primary outcome variables will be assessed by blind independent
evaluators. Manualized intervention and assessment protocols plus state-of-the art quality
assurance (i.e., weekly supervision with an expert clinician specializing specifically in OCD
treatment) and adverse event monitoring procedures will insure participant safety. Results
from this investigation will be used to support a larger controlled comparative trial
comparing the degree to which P-FIT improves outcomes for youth with OCD above and beyond
current available treatments.
