Obsessive Compulsive DisorderPhase 3NCT00533806
Comparing the Effectiveness of Two Family-based Therapies in Treating Young Children With Obsessive-Compulsive Disorder
A Phase 3 study testing Cognitive Behavior Therapy and Relaxation Therapy in people with Obsessive Compulsive Disorder, run by Rhode Island Hospital at 3 sites in United States.
Trial summary
This study will compare the effectiveness of family-based cognitive behavioral therapy to family-based relaxation therapy in treating young children with obsessive-compulsive disorder. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Cognitive Behavior Therapy and Relaxation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2007to Jan 2013
- Phase
- Phase 3
- 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meets DSM-IV criteria for OCD
- Parent willing to sign informed consent
Who cannot join
- History or current diagnosis of pervasive developmental disorder(s), thought disorder, or mental retardation
- Psychotic symptoms
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke Child and Family Study Center
Durham, North Carolina, 27705
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Brown Medical School/ Rhode Island Hospital/ Pediatric Anxiety Research Clinic
Providence, Rhode Island, 02903
About this study
Official title: Family Based Treatment for Early Childhood OCD
This study will compare the effectiveness of family-based cognitive behavioral therapy to family-based relaxation therapy in treating young children with obsessive-compulsive disorder.
Read the detailed description
Obsessive-compulsive disorder (OCD) is a type of anxiety disorder that affects approximately 1 in 200 children. Although feelings of anxiety, fear, and uncertainty are a normal part of life and growing up, for some children these feelings and emotions become chronic, relentless, and progressively worse if left untreated. OCD is characterized by obsessions, or repeated unsettling thoughts, causing a person to perform repeated actions called compulsions. Children are typically not diagnosed with OCD until they are between the ages of 8 and 12, leaving many young children undiagnosed. Additionally, no psychotherapy treatments have been designed for young children who are under the age of 8 and have OCD. The purpose of this study is to develop and evaluate a family-based treatment program for children, ages 5 to 8, who have been diagnosed with OCD.
Participants in this open-label study will be randomly assigned to receive either cognitive behavior therapy (CBT) or relaxation therapy for 12 sessions over a period of 14 weeks. All children will undergo a 3-hour screening that will include a psychiatric evaluation and the completion of questionnaires. Parents of participating children will attend the first two treatment sessions without their children during which they will be introduced to the treatment program and will learn various skills to be used throughout treatment. The other 10 1-hour sessions will be attended by both the parent and child. Participants assigned to receive CBT will learn skills to help control OCD. Education about OCD, family therapy, parent training to manage child behavior problems, and anxiety management will be included in the CBT sessions. Participants assigned to receive relaxation therapy will discuss general family functioning, issues related to OCD, and other behavioral problems the child may be experiencing. Treatment will also include education about OCD; affective education, during which participants will learn how to recognize feelings; muscle relaxation techniques; and guided imagery. Participants in both treatment groups will receive weekly homework assignments after each session to practice skills learned. Parents will also be asked to monitor their child's behavior and practice the learned skills with their child as often as possible. If treatment has not been successful after the 14-week period, the child will be offered an alternative treatment. All participants will be assessed before treatment; at 5, 9, and 14 weeks of treatment; and at 3, 6, and 12 months after treatment.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Cognitive Behavior Therapy, Relaxation Therapy
- Keywords
- Cognitive Behavior Therapy, Active Control, Relaxation Therapy, Young Children
- 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 Behavior TherapyBehavioural
CBT includes 12 treatment sessions over 14 weeks. The sessions deliver family-based exposure with response prevention. Participants assigned to receive CBT will learn skills to help control OCD. CBT sessions will also include education about OCD, family therapy, parent training to manage child behavior problems, and anxiety management.
Relaxation TherapyBehavioural
Relaxation therapy includes 12 sessions delivered over 14 weeks. Participants assigned to receive relaxation therapy will discuss general family functioning, issues related to OCD, and other behavioral problems the child may be experiencing.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy | Experimental | Participants will receive cognitive behavioral therapy. Receives: Behavioral: Cognitive Behavior Therapy |
| Relaxation therapy. | Active comparator | Participants will receive relaxation therapy. Receives: Behavioral: Relaxation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Yale-Brown Obsessive Compulsive Scale
Measured: Measured immediately post-treatment and at Months 3, 6, and 12
Secondary outcomes (1)
Clinical Global Improvement
Measured: Measured immediately post-treatment and at Months 3, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2012
- Study completionJan 2013
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jennifer B. Freeman, Rhode Island Hospital
- Investigators
- Jennifer B. Freeman, PhD, Principal investigator, Rhode Island Hospital/ Brown Medical SchoolMarty Franklin, PhD, Principal investigator, University of PennsylvaniaJohn S. March, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533806
- Sponsor's protocol ID
- R01MH079217
- Other IDs
- R01MH079217, DSIR 84-CTS
- Status last verified
- Mar 2013
- First submitted
- 19 Sep 2007
- Last updated
- 11 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Freeman J, Sapyta J, Garcia A, Compton S, Khanna M, Flessner C, FitzGerald D, Mauro C, Dingfelder R, Benito K, Harrison J, Curry J, Foa E, March J, Moore P, Franklin M. Family-based treatment of early childhood obsessive-compulsive disorder: the Pediatric Obsessive-Compulsive Disorder Treatment Study for Young Children (POTS Jr)--a randomized clinical trial. JAMA Psychiatry. 2014 Jun;71(6):689-98. doi: 10.1001/jamapsychiatry.2014.170.
PubMed 24759852
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Based Treatment for Early Childhood OCD
- ClinicalTrials.gov ID
- NCT00533806
- Acronym / sponsor ID
- R01MH079217
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- Cognitive Behavior Therapy, Active Control, Relaxation Therapy, Young Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 Sep 2007 (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.
This study will compare the effectiveness of family-based cognitive behavioral therapy to family-based relaxation therapy in treating young children with obsessive-compulsive disorder.
Detailed description
Obsessive-compulsive disorder (OCD) is a type of anxiety disorder that affects approximately 1 in 200 children. Although feelings of anxiety, fear, and uncertainty are a normal part of life and growing up, for some children these feelings and emotions become chronic, relentless, and progressively worse if left untreated. OCD is characterized by obsessions, or repeated unsettling thoughts, causing a person to perform repeated actions called compulsions. Children are typically not diagnosed with OCD until they are between the ages of 8 and 12, leaving many young children undiagnosed. Additionally, no psychotherapy treatments have been designed for young children who are under the age of 8 and have OCD. The purpose of this study is to develop and evaluate a family-based treatment program for children, ages 5 to 8, who have been diagnosed with OCD.
Participants in this open-label study will be randomly assigned to receive either cognitive behavior therapy (CBT) or relaxation therapy for 12 sessions over a period of 14 weeks. All children will undergo a 3-hour screening that will include a psychiatric evaluation and the completion of questionnaires. Parents of participating children will attend the first two treatment sessions without their children during which they will be introduced to the treatment program and will learn various skills to be used throughout treatment. The other 10 1-hour sessions will be attended by both the parent and child. Participants assigned to receive CBT will learn skills to help control OCD. Education about OCD, family therapy, parent training to manage child behavior problems, and anxiety management will be included in the CBT sessions. Participants assigned to receive relaxation therapy will discuss general family functioning, issues related to OCD, and other behavioral problems the child may be experiencing. Treatment will also include education about OCD; affective education, during which participants will learn how to recognize feelings; muscle relaxation techniques; and guided imagery. Participants in both treatment groups will receive weekly homework assignments after each session to practice skills learned. Parents will also be asked to monitor their child's behavior and practice the learned skills with their child as often as possible. If treatment has not been successful after the 14-week period, the child will be offered an alternative treatment. All participants will be assessed before treatment; at 5, 9, and 14 weeks of treatment; and at 3, 6, and 12 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy | Experimental | Behavioral: Cognitive Behavior TherapyParticipants will receive cognitive behavioral therapy. |
| Relaxation therapy. | Active comparator | Behavioral: Relaxation TherapyParticipants will receive relaxation therapy. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Meets DSM-IV criteria for OCD
- Parent willing to sign informed consent
Key exclusion criteria (2 listed)
- History or current diagnosis of pervasive developmental disorder(s), thought disorder, or mental retardation
- Psychotic symptoms
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 Behavior TherapyCBT includes 12 treatment sessions over 14 weeks. The sessions deliver family-based exposure with response prevention. Participants assigned to receive CBT will learn skills to help control OCD. CBT sessions will also include education about OCD, family therapy, parent training to manage child behavior problems, and anxiety management. | Behavioural | Cognitive behavioral therapy |
| Relaxation TherapyRelaxation therapy includes 12 sessions delivered over 14 weeks. Participants assigned to receive relaxation therapy will discuss general family functioning, issues related to OCD, and other behavioral problems the child may be experiencing. | Behavioural | Relaxation therapy. |
Primary outcome
Children's Yale-Brown Obsessive Compulsive Scale
Time frame: Measured immediately post-treatment and at Months 3, 6, and 12
1 secondary outcome
Clinical Global Improvement
Time frame: Measured immediately post-treatment and at Months 3, 6, and 12
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 11 Mar 2013.
- Derived from this study: PubMed 24759852Freeman J, Sapyta J, Garcia A, Compton S, Khanna M, Flessner C, FitzGerald D, Mauro C, Dingfelder R, Benito K, Harrison J, Curry J, Foa E, March J, Moore P, Franklin M. Family-based treatment of early childhood obsessive-compulsive disorder: the Pediatric Obsessive-Compulsive Disorder Treatment Study for Young Children (POTS Jr)--a randomized clinical trial. JAMA Psychiatry. 2014 Jun;71(6):689-98. doi: 10.1001/jamapsychiatry.2014.170.
- Click here to learn more about The Pediatric Anxiety Research ClinicLink provided by the sponsor.
- Click here to visit the Obsessive Compulsive Foundation's Web siteLink provided by the sponsor.
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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.
Jennifer B. Freeman, PhD principal investigator
Rhode Island Hospital/ Brown Medical School
Marty Franklin, PhD principal investigator
University of Pennsylvania
John S. March, MD principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive Behavior Therapy and Relaxation Therapy in people with Obsessive Compulsive Disorder, run by Rhode Island Hospital at 3 sites 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 2 inclusion and 2 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 11 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Children's Yale-Brown Obsessive Compulsive Scale (time frame: Measured immediately post-treatment and at Months 3, 6, and 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 NCT00533806, 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 11 Mar 2013.