Family Based Cognitive-Behavioral Treatment for Preschoolers With Obsessive Compulsive Disorder

NCT01447966 | Completed DMC

• 1 other identifier: YC-OCD
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Obsessive Compulsive Disorder (OCD)

Keywords

OCD; Obsessive Compulsive Disorder; Child; Pediatric; CBT; Therapy; ERP; Exposure Response Prevention; Preschool; Cognitive Behavioral

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline/Post-treatment or Post-waitlist/1 and 3 Month Follow-up

Secondary Outcomes (1)

• CYBOCS - Childrens Yale Brown Obsessive Compulsive Scale

  Baseline, post-treatment/post waitlist, 1 and 3 month followup

Study Arms (2)

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.

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

Family based cognitive behavioral therapy with exposure and response prevention. Twice weekly for 45-60 minute visits.

Also known as: ERP - Exposure response prevention

Immediate CBT

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida - Rothman Center for Neuropsychiatry

St. Petersburg, Florida, 33701, United States

Location

Related Publications (1)

• 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.

  PMID: 24657310 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Adam B Lewin, Ph.D.

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: October 6, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: March 1, 2014
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

US (1)