Family Based Cognitive-Behavioral Treatment for Preschoolers With Obsessive Compulsive Disorder
Condition: Obsessive Compulsive Disorder (OCD)
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

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.
    

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.
    

Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Family based cognitive behavioral therapy with exposure and response prevention. Twice weekly for 45-60 minute visits.
Other intervention name(s): ERP - Exposure response prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: OCD; Obsessive Compulsive Disorder; Child; Pediatric; CBT; Therapy; ERP; Exposure Response Prevention; Preschool; Cognitive Behavioral