NCT04202913

Brief Summary

School based, mental-health intervention focused on improving self-efficacy and coping skills in children aged 9-13 years. The overall premise of our intervention is that by teaching children these skills they will in-turn become more resilient when faced with life-stressors and/or adverse events.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
867

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

January 12, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

1.4 years

First QC Date

December 16, 2019

Last Update Submit

September 27, 2024

Conditions

Mental Health Wellness 1

Outcome Measures

Primary Outcomes (1)

  • Child & Youth Resilience Measure - Revised (CYRM-R)

    Assessment of a child's resiliency. Scores range from 17 (low resiliency) to 85 (high resiliency)

    12 weeks

Study Arms (1)

Health Coaching

EXPERIMENTAL

1:1 Health coaching with student

Behavioral: Coaching

Interventions

CoachingBEHAVIORAL

Child will receive 1:1 coaching with health coach.

Health Coaching

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children in participating school

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eagleview Middle School

Colorado Springs, Colorado, 80919, United States

Location

Related Publications (2)

  • Lee JA, Heberlein E, Pyle E, Caughlan T, Rahaman D, Sabin M, Kaar JL. Study protocol for a school-based single group pragmatic trial to promote resilience in youth: Building Resilience for Healthy Kids. Contemp Clin Trials Commun. 2021 Feb 6;21:100721. doi: 10.1016/j.conctc.2021.100721. eCollection 2021 Mar.

    PMID: 33665468DERIVED

  • Lee JA, Heberlein E, Pyle E, Caughlan T, Rahaman D, Sabin M, Kaar JL. Evaluation of a Resiliency Focused Health Coaching Intervention for Middle School Students: Building Resilience for Healthy Kids Program. Am J Health Promot. 2021 Mar;35(3):344-351. doi: 10.1177/0890117120959152. Epub 2020 Sep 22.

    PMID: 32959670DERIVED

Study Officials

  • Jill L Kaar, PhD

    University of Colorado Denver | Anschutz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2019

First Posted

December 18, 2019

Study Start

January 12, 2020

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Unknown at this time.

Locations

US(1)