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

NCT04922502 | Completed Results

• 1 other identifier: H-49809
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Pediatric Anxiety Rating Scale

  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 35.

  Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported.

Secondary Outcomes (2)

• Anxiety Disorders Interview Schedule (ADIS-IV) With Clinical Severity Ratings

  Up to 24 weeks

• Clinical Global Impression-Severity

  Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported.

Study Arms (2)

Standard SPACE

ACTIVE COMPARATOR

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

Bibliotherapy, low therapist contact SPACE

ACTIVE COMPARATOR

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

Interventions

Standard SPACE BEHAVIORAL

12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.

Standard SPACE

Bibliotherapy, low therapist contact SPACE BEHAVIORAL

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".

Bibliotherapy, low therapist contact SPACE

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Storch EA, Guzick AG, Ayton DM, Palo AD, Kook M, Candelari AE, Maye CE, McNeel M, Trent ES, Garcia JL, Onyeka OC, Rast CE, Shimshoni Y, Lebowitz ER, Goodman WK. Randomized trial comparing standard versus light intensity parent training for anxious youth. Behav Res Ther. 2024 Feb;173:104451. doi: 10.1016/j.brat.2023.104451. Epub 2023 Dec 17.

  PMID: 38154287 RESULT

MeSH Terms

Conditions

Anxiety, Separation; Generalized Anxiety Disorder; Panic Disorder; Obsessive-Compulsive Disorder; Anxiety Disorders

Interventions

Bibliotherapy

Condition Hierarchy (Ancestors)

Mental Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Eric Storch
• Organization: Baylor College of Medicine

eric.storch@bcm.edu

(713) 798-3579

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor is blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized assignment to one of two conditions

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 10, 2021
• Study Start: July 1, 2021
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: March 4, 2025
• Results First Posted: January 15, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)