Obsessive Compulsive Disorder (OCD)NCT01447966
Family Based Cognitive-Behavioral Treatment for Preschoolers With Obsessive Compulsive Disorder
A study testing Cognitive Behavioral Therapy in people with Obsessive Compulsive Disorder (OCD), run by University of South Florida at 1 site in United States.
Trial summary
The purpose of this research study is to further investigate how well cognitive-behavioral psychotherapy works to reduce obsessive-compulsive symptoms in young children with obsessive-compulsive disorder (OCD). Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD)
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Mar 2014
- 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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meets DSM-IV-TR for a primary diagnosis of OCD
- Minimum score of 8 on the CYBOCS compulsion scale
- Peabody Picture Vocabulary IV score of 80
- Able to attend biweekly appointments with a parent/guardian
- English Speaking
Who cannot join
- Current clinically significant suicidality
- engaged in suicidal behaviors within 6 months
- Peabody Picture Vocabulary IV score of 80
- Any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 4 weeks before study enrollment, any change in antipsychotics within 3 weeks prior to the screening assessment, any change in Prozac or Straterra within 6 weeks of study enrollment, and any change in alpha-2 agonists or stimulants within 1 week of study enrollment.
- Lifetime DSM-IV bipolar, schizophrenia or schizoaffective disorders; or Substance abuse in past 6 months.
- Absence of language
Show all 9Show fewer
- Formal diagnosis of mental retardation or an autism spectrum disorder
- Unwillingness of parents to make the commitment to accompany their child for multiple study visits, unwillingness to take part in randomization, inability to attend sessions twice weekly as therapist availability allows, inability to attend assessment visits.
- Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Florida - Rothman Center for Neuropsychiatry
St. Petersburg, Florida, 33701
About this study
The purpose of this research study is to further investigate how well cognitive-behavioral psychotherapy works to reduce obsessive-compulsive symptoms in young children with obsessive-compulsive disorder (OCD). Cognitive-behavioral therapy has been shown to work well in youth with OCD and other anxiety disorders; however, there are only a few studies to date in preschool and young children with OCD. All children will have the option to receive 12 twice-weekly cognitive-behavioral psychotherapy sessions that are up to 60-minutes each. Randomly determined, half of all children will receive these sessions immediately following the pre-assessment and the remaining half will receive them after six weeks. The investigators expect that youth receiving the study-based therapy will show more improvement in OCD symptoms in six weeks in contrast to youth waiting to receive the therapy.
Read the detailed description
Cognitive Behavioral Therapy for OCD includes several core therapeutic elements including establishment of treatment goals, assigned homework, operant conditioning paradigms (the putative mechanism for exposure-based therapies), provision of psychoeducation (e.g., the link between thoughts, feelings, and behaviors), cognitive (e.g., cognitive restructuring) and behavioral (e.g., exposure) coping skill implementation, and target behavior progress assessments. Nevertheless, research is lacking in preschoolers with OCD and these children likely require adaptations to the traditional CBT regimen. Preschoolers often have a high level of family accommodation, whereby the family members become part of the rituals and compulsions in attempt to ease the young child's anxiety. CBT with preschoolers will need to emphasize delivering intervention within the context of the family. The flexibility of this modular approach for treatment (modular therapies allow for variations in the order and intensiveness of the aforementioned treatment elements, providing an individually tailored treatment instead of a one-size-fits-all approach) may be optimally suited for preschoolers with OCD given their wide variability in developmental level and symptom presentation. This is consistent with the NIH Roadmap Initiative which calls for personalized interventions matched to individual patient characteristics. Our OCD research team in the Rothman Center is highly experienced in clinical research for pediatric and adult OCD. The proposed investigation is a single-site controlled trial of CBT in preschool aged youth with OCD aged 3-8 years. We will randomly assign patients to immediate treatment or 6-week Treatment as Usual (TAU) control. A manualized CBT protocol will be followed. Assessments will occur at Screening, Baseline, Post-treatment and 1 and 3-month follow-ups. Ratings of patient OCD symptom severity will be conducted at each time point by trained raters blinded to treatment condition. Diagnosis will be established by an experienced clinician and verified by a validated rating scale conducted with the child's parent(s); cases will be reviewed by study investigators. Assessments will be audio-recorded and verified for integrity. Randomization will be determined immediately following the baseline assessment; patients will be assigned TAU or immediate treatment in a 1:1 ratio. All eligible patients will receive 12 therapy sessions over 6 weeks using the evidence-based treatment protocol that incorporates E/RP and parent involvement; sessions are twice weekly for 60 minutes. Dr. Lewin and other trained OCD therapists under his supervision will conduct therapy sessions. All sessions are audiorecorded for integrity.
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- OCD, Obsessive Compulsive Disorder, Child, Pediatric, CBT, Therapy, ERP, Exposure Response Prevention, Preschool, Cognitive Behavioral
- 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.
Cognitive Behavioral TherapyBehavioural
Also called ERP - Exposure response prevention
Family based cognitive behavioral therapy with exposure and response prevention. Twice weekly for 45-60 minute visits.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | Participants randomized to the TAU arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice. |
| Immediate CBT | Experimental | Therapists will work with families for 12 twice weekly sessions, each lasting up to 60 minutes implementing a developmentally appropriate modulated cognitive behavioral therapy approach. A manualized CBT protocol will be followed. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Global Impression - Improvement Scale (Measure of patient improvement at relevent timepoints)
The CGI is a 7-point rating of treatment response anchored by 1 ("very much improved), 4 ("no change") and 7 ("very much worse"). Youth being rated by the IE as 1 ("very much improved") and 2 ("much improved") will be considered treatment responders. This measure assesses change or improvement across time and consequently is appropriate for use at multiple assessments - reflects patient improvement relative to baseline functioning. Represents change in functioning and assesses change in baseline. Appropriate for use at multiple time-points.
Measured: Baseline/Post-treatment or Post-waitlist/1 and 3 Month Follow-up
Secondary outcomes (1)
CYBOCS - Childrens Yale Brown Obsessive Compulsive Scale
The CY-BOCS is a 10-item semi-structured measure of obsession and compulsion severity over the previous week. Measure will be administered to the parent.
Change score (calculated as a percent change from baseline) will be used as the outcome measure.
Measured: Baseline, post-treatment/post waitlist, 1 and 3 month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2013
- Study completionMar 2014
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 Disorder (OCD)Studies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Lewin, University of South Florida
- Investigators
- Adam B Lewin, Ph.D., Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447966
- Sponsor's protocol ID
- YC-OCD
- Status last verified
- Mar 2014
- First submitted
- 29 Sep 2011
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lewin AB, Park JM, Jones AM, Crawford EA, De Nadai AS, Menzel J, Arnold EB, Murphy TK, Storch EA. Family-based exposure and response prevention therapy for preschool-aged children with obsessive-compulsive disorder: a pilot randomized controlled trial. Behav Res Ther. 2014 May;56:30-8. doi: 10.1016/j.brat.2014.02.001. Epub 2014 Mar 2.
PubMed 24657310
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Based Cognitive-Behavioral Treatment for Preschoolers With Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT01447966
- Acronym / sponsor ID
- YC-OCD
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Keywords
- OCD, Obsessive Compulsive Disorder, Child, Pediatric, CBT, Therapy, ERP, Exposure Response Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 6 Oct 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.
The purpose of this research study is to further investigate how well cognitive-behavioral psychotherapy works to reduce obsessive-compulsive symptoms in young children with obsessive-compulsive disorder (OCD). Cognitive-behavioral therapy has been shown to work well in youth with OCD and other anxiety disorders; however, there are only a few studies to date in preschool and young children with OCD. All children will have the option to receive 12 twice-weekly cognitive-behavioral psychotherapy sessions that are up to 60-minutes each. Randomly determined, half of all children will receive these sessions immediately following the pre-assessment and the remaining half will receive them after six weeks. The investigators expect that youth receiving the study-based therapy will show more improvement in OCD symptoms in six weeks in contrast to youth waiting to receive the therapy.
Detailed description
Cognitive Behavioral Therapy for OCD includes several core therapeutic elements including establishment of treatment goals, assigned homework, operant conditioning paradigms (the putative mechanism for exposure-based therapies), provision of psychoeducation (e.g., the link between thoughts, feelings, and behaviors), cognitive (e.g., cognitive restructuring) and behavioral (e.g., exposure) coping skill implementation, and target behavior progress assessments. Nevertheless, research is lacking in preschoolers with OCD and these children likely require adaptations to the traditional CBT regimen. Preschoolers often have a high level of family accommodation, whereby the family members become part of the rituals and compulsions in attempt to ease the young child's anxiety. CBT with preschoolers will need to emphasize delivering intervention within the context of the family. The flexibility of this modular approach for treatment (modular therapies allow for variations in the order and intensiveness of the aforementioned treatment elements, providing an individually tailored treatment instead of a one-size-fits-all approach) may be optimally suited for preschoolers with OCD given their wide variability in developmental level and symptom presentation. This is consistent with the NIH Roadmap Initiative which calls for personalized interventions matched to individual patient characteristics. Our OCD research team in the Rothman Center is highly experienced in clinical research for pediatric and adult OCD. The proposed investigation is a single-site controlled trial of CBT in preschool aged youth with OCD aged 3-8 years. We will randomly assign patients to immediate treatment or 6-week Treatment as Usual (TAU) control. A manualized CBT protocol will be followed. Assessments will occur at Screening, Baseline, Post-treatment and 1 and 3-month follow-ups. Ratings of patient OCD symptom severity will be conducted at each time point by trained raters blinded to treatment condition. Diagnosis will be established by an experienced clinician and verified by a validated rating scale conducted with the child's parent(s); cases will be reviewed by study investigators. Assessments will be audio-recorded and verified for integrity. Randomization will be determined immediately following the baseline assessment; patients will be assigned TAU or immediate treatment in a 1:1 ratio. All eligible patients will receive 12 therapy sessions over 6 weeks using the evidence-based treatment protocol that incorporates E/RP and parent involvement; sessions are twice weekly for 60 minutes. Dr. Lewin and other trained OCD therapists under his supervision will conduct therapy sessions. All sessions are audiorecorded for integrity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –Participants randomized to the TAU arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice. |
| Immediate CBT | Experimental | Behavioral: Cognitive Behavioral TherapyTherapists will work with families for 12 twice weekly sessions, each lasting up to 60 minutes implementing a developmentally appropriate modulated cognitive behavioral therapy approach. A manualized CBT protocol will be followed. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Meets DSM-IV-TR for a primary diagnosis of OCD
- Minimum score of 8 on the CYBOCS compulsion scale
- Peabody Picture Vocabulary IV score of 80
- Able to attend biweekly appointments with a parent/guardian
- English Speaking
Key exclusion criteria (9 listed)
- Current clinically significant suicidality
- engaged in suicidal behaviors within 6 months
- Peabody Picture Vocabulary IV score of 80
- Any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 4 weeks before study enrollment, any change in antipsychotics within 3 weeks prior to the screening assessment, any change in Prozac or Straterra within 6 weeks of study enrollment, and any change in alpha-2 agonists or stimulants within 1 week of study enrollment.
- Lifetime DSM-IV bipolar, schizophrenia or schizoaffective disorders; or Substance abuse in past 6 months.
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 |
|---|---|---|
| Cognitive Behavioral TherapyAlso: ERP - Exposure response preventionFamily based cognitive behavioral therapy with exposure and response prevention. Twice weekly for 45-60 minute visits. | Behavioural | Immediate CBT |
Primary outcome
Clinician Global Impression - Improvement Scale (Measure of patient improvement at relevent timepoints)
Time frame: Baseline/Post-treatment or Post-waitlist/1 and 3 Month Follow-up
The CGI is a 7-point rating of treatment response anchored by 1 ("very much improved), 4 ("no change") and 7 ("very much worse"). Youth being rated by the IE as 1 ("very much improved") and 2 ("much improved") will be considered treatment responders. This measure assesses change or improvement across time and consequently is appropriate for use at multiple assessments - reflects patient improvement relative to baseline functioning. Represents change in functioning and assesses change in baseline. Appropriate for use at multiple time-points.
1 secondary outcome
CYBOCS - Childrens Yale Brown Obsessive Compulsive Scale
Time frame: Baseline, post-treatment/post waitlist, 1 and 3 month followup
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 26 Mar 2014.
- Derived from this study: PubMed 24657310Lewin AB, Park JM, Jones AM, Crawford EA, De Nadai AS, Menzel J, Arnold EB, Murphy TK, Storch EA. Family-based exposure and response prevention therapy for preschool-aged children with obsessive-compulsive disorder: a pilot randomized controlled trial. Behav Res Ther. 2014 May;56:30-8. doi: 10.1016/j.brat.2014.02.001. Epub 2014 Mar 2.
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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.
Adam B Lewin, Ph.D. principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Obsessive Compulsive Disorder (OCD), run by University of South Florida 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 5 inclusion and 9 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 26 Mar 2014. 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?
Clinician Global Impression - Improvement Scale (Measure of patient improvement at relevent timepoints) (time frame: Baseline/Post-treatment or Post-waitlist/1 and 3 Month Follow-up). 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 NCT01447966, 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 26 Mar 2014.