School Based Prevention for Childhood Anxiety

This study was designed to conceptualize a school-based prevention program or childhood anxiety.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders
• Intervention / Treatment: Behavioral: REACH for Success; Behavioral: Self-Study

Detailed Description

This is a project corresponding to a career development grant. The main goal of the proposed research was to identify potential barriers to implementing a school-based anxiety preventive intervention, identify strategies to overcome these barriers, and use this information to test a school-based indicated intervention for child anxiety.

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion:

Borderline child anxiety levels based on the Spence Child Anxiety Scale

Exclusion:

Externalizing problems (based on teacher nominations) more severe than Spence Child Anxiety Scale borderline levels

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: REACH for Success; Experimental: Exposure-based, cognitive and behavioral, social skills training intervention 6-weeks - 6 session -20-30 min each	Behavioral: REACH for Success; Exposure-based cognitive behavioral with social skill training (cognitive self control, relaxation, skills for conversations and assertiveness)
Active Comparator: Active Comparator: Self-study; Active Comparator: Books "What to do when you are scared and worried?How to do homework without throwing-up? How to get organized without losing it?" Reading at home	Behavioral: Self-Study; Books for youth about anxiety management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in child anxiety symptoms (clinical)	Child anxiety symptoms based on the Multidimensional Anxiety Scale for Children	Change from baseline to 12-month follow-up
Change in child anxiety levels (typical)	Child anxiety based on the Spence Child Anxiety Scale	Change from baseline to 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in child negative cognition	Children's Negative Cognitive Errors on the Children's Negative Cognitive Errors Questionnaire	Change from baseline to immediate posttest (at 6-weeks)
Changes in child negative cognition	Children's Negative Cognitive Errors on the Children's Negative Cognitive Errors Questionnaire	Change from baseline to 12-month follow-up
Changes in emotion understanding and expression	Children's Emotion Expressivity based on the Emotion Expressivity Scale for Children	Change from baseline to immediate posttest (at 6-weeks)
Changes in emotion understanding and expression	Children's Emotion Expressivity based on the Emotion Expressivity Scale for Children	Change from baseline to 12-month follow-up)
Changes in self efficacy	Child self efficacy based on the Children's Self-Efficacy Questionnaire for Handling School Situations	Change from baseline to immediate posttest (at 6-weeks)
Changes in self efficacy	Child self efficacy based on the Children's Self-Efficacy Questionnaire for Handling School Situations	Change from baseline to 12-month follow-up)
Changes in child social skills	Child social skills based on the Social Skills Improvement Rating System	Change from baseline to immediate posttest (at 6-weeks)
Changes in child social skills	Child social skills based on the Social Skills Improvement Rating System	Change from baseline to 12-month follow-up)
Changes in somatic arousal	Child somatic arousal based on the Physiological Hyperarousal Scale for Children	Change from baseline to immediate posttest (at 6-weeks)
Changes in somatic arousal	Child somatic arousal based on the Physiological Hyperarousal Scale for Children	Change from baseline to 12-month follow-up)

Collaborators and Investigators

• Sponsor: Arizona State University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Estimate): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: MH086687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No