History of Changes for Study: NCT04922502

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

Latest version (submitted February 13, 2024) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	June 4, 2021	None (earliest Version on record)
2	August 26, 2021	Recruitment Status, Study Status, Contacts/Locations and Oversight
3	January 28, 2022	Study Status and Sponsor/Collaborators
4	September 11, 2022	Study Status
5	November 7, 2022	Study Status
6	February 7, 2023	Recruitment Status, Study Status and Contacts/Locations
7	May 9, 2023	Study Status
8	July 28, 2023	Study Status
9	February 13, 2024	Recruitment Status, Study Status and Study Design

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Study NCT04922502
Submitted Date: June 4, 2021 (v1)

Study Identification


Unique Protocol ID:	H-49809
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
Secondary IDs:

Study Status


Record Verification:	June 2021
Overall Status:	Not yet recruiting
Study Start:	July 1, 2021
Primary Completion:	June 30, 2023 [Anticipated]
Study Completion:	June 30, 2023 [Anticipated]

First Submitted:	May 25, 2021
First Submitted that Met QC Criteria:	June 4, 2021
First Posted:	June 10, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	June 4, 2021
Last Update Posted:	June 10, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	Baylor College of Medicine
Responsible Party:	Principal Investigator Investigator: A Storch Official Title: Professor Affiliation: Baylor College of Medicine
Collaborators:

Study Description

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.

Conditions


Conditions:	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
Keywords:	obsessive-compulsive disorder children cognitive behavioral therapy anxiety

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2/Phase 3
Interventional Study Model:	Parallel Assignment
	Randomized assignment to one of two conditions
Number of Arms:	2
Masking:	Single (Outcomes Assessor)
Allocation:	Randomized
Enrollment:	60 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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.	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.
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".	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".

Outcome Measures


Primary Outcome Measures:
1.	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.
Secondary Outcome Measures:
1.	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.
2.	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).

Eligibility


Minimum Age:	7 Years
Maximum Age:	17 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
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).

Contacts/Locations


Central Contact Person:	Saira A Weinzimmer, BA Telephone: 713-798-8563 Email: weinzimm@bcm.edu
Central Contact Backup:	Andrew G Guzick, PhD Telephone: 832-824-1000 Email: andrew.guzick@bcm.edu
Locations:	United States, Texas
	Baylor College of Medicine Houston, Texas, United States, 77030

References


Citations:	[Study Results] 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. PubMed 30851397
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