Family Focused Treatment of Pediatric Obsessive Compulsive Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 8 - 17 |
| Updated: | 4/21/2016 |
| Start Date: | January 2008 |
| End Date: | December 2016 |
Pilot Feasibility Trial of Positive Family Interaction Therapy
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.
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.
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.
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.
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.
We found this trial at
1
site
Los Angeles, California 90095
310-825-4321
Principal Investigator: Tara S Peris, Ph.D.
Phone: 310-794-4347
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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