Back to resultsSchool Based Prevention for Childhood Anxiety
Primary Purpose
Anxiety Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
REACH for Success
Self-Study
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety Disorders
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental: REACH for Success
Active Comparator: Self-study
Arm Description
Experimental: Exposure-based, cognitive and behavioral, social skills training intervention 6-weeks - 6 session -20-30 min each
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
Outcomes
Primary Outcome Measures
Change in child anxiety symptoms (clinical)
Child anxiety symptoms based on the Multidimensional Anxiety Scale for Children
Change in child anxiety levels (typical)
Child anxiety based on the Spence Child Anxiety Scale
Secondary Outcome Measures
Changes in child negative cognition
Children's Negative Cognitive Errors on the Children's Negative Cognitive Errors Questionnaire
Changes in child negative cognition
Children's Negative Cognitive Errors on the Children's Negative Cognitive Errors Questionnaire
Changes in emotion understanding and expression
Children's Emotion Expressivity based on the Emotion Expressivity Scale for Children
Changes in emotion understanding and expression
Children's Emotion Expressivity based on the Emotion Expressivity Scale for Children
Changes in self efficacy
Child self efficacy based on the Children's Self-Efficacy Questionnaire for Handling School Situations
Changes in self efficacy
Child self efficacy based on the Children's Self-Efficacy Questionnaire for Handling School Situations
Changes in child social skills
Child social skills based on the Social Skills Improvement Rating System
Changes in child social skills
Child social skills based on the Social Skills Improvement Rating System
Changes in somatic arousal
Child somatic arousal based on the Physiological Hyperarousal Scale for Children
Changes in somatic arousal
Child somatic arousal based on the Physiological Hyperarousal Scale for Children
Full Information
NCT ID
NCT03044678
First Posted
January 30, 2017
Last Updated
February 6, 2017
Sponsor
Arizona State University
1. Study Identification
Unique Protocol Identification Number
NCT03044678
Brief Title
School Based Prevention for Childhood Anxiety
Official Title
School Based Prevention for Childhood Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2010 (Actual)
Primary Completion Date
January 1, 2015 (Actual)
Study Completion Date
January 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was designed to conceptualize a school-based prevention program or childhood anxiety.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Masked or blinded to hypotheses
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: REACH for Success
Arm Type
Experimental
Arm Description
Experimental: Exposure-based, cognitive and behavioral, social skills training intervention 6-weeks - 6 session -20-30 min each
Arm Title
Active Comparator: Self-study
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
REACH for Success
Intervention Description
Exposure-based cognitive behavioral with social skill training (cognitive self control, relaxation, skills for conversations and assertiveness)
Intervention Type
Behavioral
Intervention Name(s)
Self-Study
Intervention Description
Books for youth about anxiety management
Primary Outcome Measure Information:
Title
Change in child anxiety symptoms (clinical)
Description
Child anxiety symptoms based on the Multidimensional Anxiety Scale for Children
Time Frame
Change from baseline to 12-month follow-up
Title
Change in child anxiety levels (typical)
Description
Child anxiety based on the Spence Child Anxiety Scale
Time Frame
Change from baseline to 12-month follow-up
Secondary Outcome Measure Information:
Title
Changes in child negative cognition
Description
Children's Negative Cognitive Errors on the Children's Negative Cognitive Errors Questionnaire
Time Frame
Change from baseline to immediate posttest (at 6-weeks)
Title
Changes in child negative cognition
Description
Children's Negative Cognitive Errors on the Children's Negative Cognitive Errors Questionnaire
Time Frame
Change from baseline to 12-month follow-up
Title
Changes in emotion understanding and expression
Description
Children's Emotion Expressivity based on the Emotion Expressivity Scale for Children
Time Frame
Change from baseline to immediate posttest (at 6-weeks)
Title
Changes in emotion understanding and expression
Description
Children's Emotion Expressivity based on the Emotion Expressivity Scale for Children
Time Frame
Change from baseline to 12-month follow-up)
Title
Changes in self efficacy
Description
Child self efficacy based on the Children's Self-Efficacy Questionnaire for Handling School Situations
Time Frame
Change from baseline to immediate posttest (at 6-weeks)
Title
Changes in self efficacy
Description
Child self efficacy based on the Children's Self-Efficacy Questionnaire for Handling School Situations
Time Frame
Change from baseline to 12-month follow-up)
Title
Changes in child social skills
Description
Child social skills based on the Social Skills Improvement Rating System
Time Frame
Change from baseline to immediate posttest (at 6-weeks)
Title
Changes in child social skills
Description
Child social skills based on the Social Skills Improvement Rating System
Time Frame
Change from baseline to 12-month follow-up)
Title
Changes in somatic arousal
Description
Child somatic arousal based on the Physiological Hyperarousal Scale for Children
Time Frame
Change from baseline to immediate posttest (at 6-weeks)
Title
Changes in somatic arousal
Description
Child somatic arousal based on the Physiological Hyperarousal Scale for Children
Time Frame
Change from baseline to 12-month follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
School Based Prevention for Childhood Anxiety
We'll reach out to this number within 24 hrs