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Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder

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ClinicalTrials.gov Identifier: NCT04922502
Recruitment Status : Recruiting
First Posted : June 10, 2021
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Eric A Storch, Baylor College of Medicine

Tracking Information
First Submitted Date  ICMJE May 25, 2021
First Posted Date  ICMJE June 10, 2021
Last Update Posted Date February 1, 2022
Actual Study Start Date  ICMJE July 1, 2021
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2021)
Pediatric Anxiety Rating Scale [ Time Frame: 7 days ]
Clinician-rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 30.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2021)
  • Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings [ Time Frame: Up to 24 weeks ]
    Clinician-rated diagnostic interview that includes current anxiety disorders, depression, obsessive-compulsive disorder, and related disorders. Each diagnostic category is coded as present or absent based on symptom criteria and clinical severity ratings (CSRs), which indicate the level of clinical interference. CSRs are scored on a 0-8 scale (0 = not at all; 8 = very, very much). CSRs of 4 or above indicate the clinical levels.
  • Clinical Global Impression-Severity [ Time Frame: 7 days ]
    Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder
Official Title  ICMJE Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder: Comparison of Therapist-Led and Therapist Assisted Approaches
Brief Summary Anxiety and obsessive-compulsive disorders are the most common mental health disorders in childhood and adolescence. A parenting intervention for youth with anxiety, called Supportive Parenting of Anxious Childhood Emotions ("SPACE"), has been recently developed to help target anxiety in children. In this intervention, therapists meet individually with parents to help them reduce anxiety behaviors in their children and support adaptive behaviors in their children. The purpose for the proposed study is to demonstrate the treatment efficacy of SPACE compared to a low-contact, therapist-supported bibliotherapy version of this intervention.
Detailed Description Anxiety and obsessive-compulsive disorders are the most common mental health disorders in childhood and adolescence. Parental accommodation of their children's avoidance, escape, safety behaviors are a set of parenting behaviors that have been most strongly associated with child anxiety and obsessive-compulsive disorder. Developing and testing parent-led interventions that target accommodation and parenting styles associated with anxiety has the potential to improve treatment outcomes and reach families who may not otherwise access care (for example, for youth who refuse to attend therapy). A parenting intervention for youth with anxiety has been recently developed to address these goals called Supportive Parenting of Anxious Childhood Emotions ("SPACE"). In this intervention, therapists meet individually with parents to help them reduce accommodation and support adaptive behaviors in their children. SPACE was recently shown to be non-inferior to individual cognitive-behavioral therapy with 88% of youth being classified as responders to SPACE. The purpose for the proposed study is to demonstrate the treatment efficacy of SPACE compared to a low-contact, therapist-supported bibliotherapy version of this intervention, providing efficacy evidence for SPACE as delivered by an independent investigatory group.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized assignment to one of two conditions
Masking: Single (Outcomes Assessor)
Masking Description:
Outcomes assessor is blinded
Primary Purpose: Treatment
Condition  ICMJE
  • Obsessive-Compulsive Disorder in Children
  • Social Anxiety Disorder of Childhood
  • Obsessive-Compulsive Disorder in Adolescence
  • Separation Anxiety
  • Generalized Anxiety Disorder
  • Panic Disorder
  • Panic Attacks
  • Panic With Agoraphobia
Intervention  ICMJE
  • Behavioral: Standard SPACE
    12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.
  • Behavioral: Bibliotherapy, low therapist contact SPACE
    4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".
Study Arms  ICMJE
  • Active Comparator: Standard SPACE
    12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.
    Intervention: Behavioral: Standard SPACE
  • Active Comparator: Bibliotherapy, low therapist contact SPACE
    4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".
    Intervention: Behavioral: Bibliotherapy, low therapist contact SPACE
Publications * Lebowitz ER, Marin C, Martino A, Shimshoni Y, Silverman WK. Parent-Based Treatment as Efficacious as Cognitive-Behavioral Therapy for Childhood Anxiety: A Randomized Noninferiority Study of Supportive Parenting for Anxious Childhood Emotions. J Am Acad Child Adolesc Psychiatry. 2020 Mar;59(3):362-372. doi: 10.1016/j.jaac.2019.02.014. Epub 2019 Mar 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The child is between the ages of 7 to 17 at enrollment
  • The child has clinically significant symptoms of anxiety and/or OCD, as indicated by a score of 12 or higher on the Pediatric Anxiety Rating Scale (PARS).
  • The child is appropriate for anxiety-focused treatment (e.g., anxiety is the primary problem as diagnosed using the Anxiety Disorders Interview Schedule (ADIS), and if secondary psychopathology is present it will not interfere with treatment).
  • One parent/guardian is able and willing to participate in assessment and treatment (e.g., has sufficient English fluency, the decisional capacity to participate, and can commit to treatment duration).
  • The participating parent/guardian lives with their child at least 50% of the time.
  • Both parent and child are able to read and understand English.
  • The child is able to communicate verbally.
  • Participants must reside in Texas and parents must be in the state of Texas when taking calls.

Exclusion Criteria:

  • the child has a diagnosis of child lifetime bipolar disorder, drug of alcohol abuse, intellectual or developmental disability, psychotic disorder, or conduct disorder.
  • the child has severe, current suicidal/homicidal ideation and/or self-injury requiring medical intervention (referrals will be made for appropriate clinical intervention).
  • the child is receiving concurrent evidence-based psychotherapy for anxiety, involving exposure therapy in at least 50% of sessions.
  • the child has initiated or changed dosage of psychotropic medications within 4 weeks before study enrollment OR stimulant or benzodiazepine medications within 2 weeks before study enrollment. If appropriate, the child may be enrolled in the study once medication dosage has stabilized (i.e., 4 weeks for psychotropic medication or 2 weeks for stimulant/benzodiazepine medication).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Saira A Weinzimmer, BA 713-798-8563 weinzimm@bcm.edu
Contact: Andrew G Guzick, PhD 832-824-1000 andrew.guzick@bcm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04922502
Other Study ID Numbers  ICMJE H-49809
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eric A Storch, Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Baylor College of Medicine
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP