NCT03044678

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

5 years

First QC Date

January 30, 2017

Last Update Submit

February 6, 2017

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Changes in child negative cognition

    Change from baseline to immediate posttest (at 6-weeks)

  • Changes in child negative cognition

    Change from baseline to 12-month follow-up

  • Changes in emotion understanding and expression

    Change from baseline to immediate posttest (at 6-weeks)

  • Changes in emotion understanding and expression

    Change from baseline to 12-month follow-up)

  • Changes in self efficacy

    Change from baseline to immediate posttest (at 6-weeks)

  • +5 more secondary outcomes

Study Arms (2)

Experimental: REACH for Success

EXPERIMENTAL

Experimental: Exposure-based, cognitive and behavioral, social skills training intervention 6-weeks - 6 session -20-30 min each

Behavioral: REACH for Success

Active Comparator: Self-study

ACTIVE COMPARATOR

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

Interventions

REACH for SuccessBEHAVIORAL

Exposure-based cognitive behavioral with social skill training (cognitive self control, relaxation, skills for conversations and assertiveness)

Experimental: REACH for Success
Self-StudyBEHAVIORAL

Books for youth about anxiety management

Active Comparator: Self-study

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Borderline child anxiety levels based on the Spence Child Anxiety Scale

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Masked or blinded to hypotheses
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 7, 2017

Study Start

January 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 7, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share