Comparing the Effectiveness of Two Family-based Therapies in Treating Young Children With Obsessive-Compulsive Disorder
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): Cognitive Behavior Therapy; Relaxation Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Behavior Therapy; Active Control; Relaxation Therapy; Young Children