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

• ClinicalTrials.gov Identifier: NCT04922502
• Recruitment Status: Completed
• First Posted: June 10, 2021
• Last Update Posted: February 14, 2024
• Sponsor: Baylor College of Medicine
• Information provided by (Responsible Party): Eric A Storch, Baylor College of Medicine

Tracking Information

• First Submitted Date: May 25, 2021
• First Posted Date: June 10, 2021
• Last Update Posted Date: February 14, 2024
• Actual Study Start Date: July 1, 2021
• Actual Primary Completion Date: December 22, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder
• Official Title: 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: Interventional
• Study Phase: Phase 2; Phase 3

Study Design

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

• 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

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 13, 2024): 68
• Original Estimated Enrollment (submitted: June 4, 2021): 60
• Actual Study Completion Date: December 22, 2023
• Actual Primary Completion Date: December 22, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 7 Years to 17 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04922502
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Eric A Storch, Baylor College of Medicine
• Original Responsible Party: A Storch, Baylor College of Medicine, Professor
• Current Study Sponsor: Baylor College of Medicine
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Baylor College of Medicine
• Verification Date: February 2024