Obsessive-Compulsive DisorderPFITNCT01409642
Family Focused Treatment of Pediatric Obsessive Compulsive Disorder
A study testing Individual Child CBT and Positive Family Interaction Therapy in people with Obsessive-Compulsive Disorder, run by University of California, Los Angeles at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Individual Child CBT and Positive Family Interaction Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Individual Child CBT, Positive Family Interaction Therapy
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Child CBTBehavioural
Also called child cognitive behavior therapy
12 sessions of individual child focused cognitive behavior therapy with a parent component
Positive Family Interaction TherapyBehavioural
Six sessions of family-focused treatment for childhood OCD administered as an adjunct to 12 sessions of child CBT
Positive Family Interaction TherapyBehavioural
Also called PFIT
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.
| Study group | Role | What they receive |
|---|---|---|
| Individual Child CBT | Active comparator | 12 sessions of individual child-focused cognitive behavior therapy with a parent component Receives: 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) Receives: Behavioral: Positive Family Interaction Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-treatment (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startJan 2008
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tara Peris, University of California, Los Angeles
- Investigators
- Tara S Peris, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409642
- Sponsor's protocol ID
- K23MH085058
- Acronym
- PFIT
- Status last verified
- May 2021
- First submitted
- 12 Oct 2010
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29173737
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Trial of Positive Family Interaction Therapy
- ClinicalTrials.gov ID
- NCT01409642
- Acronym / sponsor ID
- PFIT / K23MH085058
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Child CBT | Active comparator | Behavioral: Individual Child CBT12 sessions of individual child-focused cognitive behavior therapy with a parent component |
| Positive Family Interaction Therapy | Experimental | Behavioral: Positive Family Interaction Therapy12 sessions of standard individual child CBT plus six sessions of positive family interaction therapy (PFIT) |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual Child CBTAlso: child cognitive behavior therapy12 sessions of individual child focused cognitive behavior therapy with a parent component | Behavioural | Individual Child CBT |
| Positive Family Interaction TherapySix sessions of family-focused treatment for childhood OCD administered as an adjunct to 12 sessions of child CBT | Behavioural | Positive Family Interaction Therapy |
| Positive Family Interaction TherapyAlso: PFITPositive 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. | Behavioural | Positive Family Interaction Therapy |
Primary outcome
OCD symptom severity on the Children's Yale Brown Obsessive Compulsive Scale (CYBOCS)
Time frame: Post-treatment (week 12)
Treatment outcome will be evaluated based on decreases in total OCD symptom severity as measured by the CYBOCS.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Derived from this study: PubMed 29173737Peris 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tara S Peris, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Child CBT and Positive Family Interaction Therapy in people with Obsessive-Compulsive Disorder, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCD symptom severity on the Children's Yale Brown Obsessive Compulsive Scale (CYBOCS) (time frame: Post-treatment (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01409642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.