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School Based Prevention for Childhood Anxiety

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ClinicalTrials.gov Identifier: NCT03044678
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Armando Pina, Arizona State University

Tracking Information
First Submitted Date  ICMJE January 30, 2017
First Posted Date  ICMJE February 7, 2017
Last Update Posted Date February 7, 2017
Actual Study Start Date  ICMJE January 1, 2010
Actual Primary Completion Date January 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2017)
  • Change in child anxiety symptoms (clinical) [ Time Frame: Change from baseline to 12-month follow-up ]
    Child anxiety symptoms based on the Multidimensional Anxiety Scale for Children
  • Change in child anxiety levels (typical) [ Time Frame: Change from baseline to 12-month follow-up ]
    Child anxiety based on the Spence Child Anxiety Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2017)
  • Changes in child negative cognition [ Time Frame: Change from baseline to immediate posttest (at 6-weeks) ]
    Children's Negative Cognitive Errors on the Children's Negative Cognitive Errors Questionnaire
  • Changes in child negative cognition [ Time Frame: Change from baseline to 12-month follow-up ]
    Children's Negative Cognitive Errors on the Children's Negative Cognitive Errors Questionnaire
  • Changes in emotion understanding and expression [ Time Frame: Change from baseline to immediate posttest (at 6-weeks) ]
    Children's Emotion Expressivity based on the Emotion Expressivity Scale for Children
  • Changes in emotion understanding and expression [ Time Frame: Change from baseline to 12-month follow-up) ]
    Children's Emotion Expressivity based on the Emotion Expressivity Scale for Children
  • Changes in self efficacy [ Time Frame: Change from baseline to immediate posttest (at 6-weeks) ]
    Child self efficacy based on the Children's Self-Efficacy Questionnaire for Handling School Situations
  • Changes in self efficacy [ Time Frame: Change from baseline to 12-month follow-up) ]
    Child self efficacy based on the Children's Self-Efficacy Questionnaire for Handling School Situations
  • Changes in child social skills [ Time Frame: Change from baseline to immediate posttest (at 6-weeks) ]
    Child social skills based on the Social Skills Improvement Rating System
  • Changes in child social skills [ Time Frame: Change from baseline to 12-month follow-up) ]
    Child social skills based on the Social Skills Improvement Rating System
  • Changes in somatic arousal [ Time Frame: Change from baseline to immediate posttest (at 6-weeks) ]
    Child somatic arousal based on the Physiological Hyperarousal Scale for Children
  • Changes in somatic arousal [ Time Frame: Change from baseline to 12-month follow-up) ]
    Child somatic arousal based on the Physiological Hyperarousal Scale for Children
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE School Based Prevention for Childhood Anxiety
Official Title  ICMJE School Based Prevention for Childhood Anxiety
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
Masked or blinded to hypotheses
Primary Purpose: Prevention
Condition  ICMJE Anxiety Disorders
Intervention  ICMJE
  • Behavioral: REACH for Success
    Exposure-based cognitive behavioral with social skill training (cognitive self control, relaxation, skills for conversations and assertiveness)
  • Behavioral: Self-Study
    Books for youth about anxiety management
Study Arms  ICMJE
  • Experimental: Experimental: REACH for Success
    Experimental: Exposure-based, cognitive and behavioral, social skills training intervention 6-weeks - 6 session -20-30 min each
    Intervention: Behavioral: REACH for Success
  • 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
    Intervention: Behavioral: Self-Study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2017)
109
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2015
Actual Primary Completion Date January 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03044678
Other Study ID Numbers  ICMJE MH086687
Has Data Monitoring Committee Yes
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  ICMJE
Plan to Share IPD: No
Responsible Party Armando Pina, Arizona State University
Study Sponsor  ICMJE Arizona State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Arizona State University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP