- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04202913
Building Resilience for Healthy Kids
February 2, 2023 updated by: University of Colorado, Denver
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.
Study Overview
Detailed Description
Healthy Kids is a 1:1 health coaching intervention delivered in school-settings.
Students meet weekly with their assigned health coach and together they identify both strengths and areas for improvement with respect to resilience, developing resilience skills, and setting resilience goals.
Topics discussed include coping skills, self-efficacy, and interpersonal relationships.
The program was developed using the social determination theory (SDT), goal theory, and elements from the social-ecological model.
SDT was used within the intervention to promote and facilitate behavior change.
Goal theory was also utilized to develop strategies to support youth short- and long-term goal setting.
Finally, weekly discussions about resilience and goal setting activities accounted for elements of the social-ecological model which acknowledges that behaviors are not independent factors, but are influenced by multiple levels of one's personal and social environment.
Study Type
Interventional
Enrollment (Actual)
867
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80919
- Eagleview Middle School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 13 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All children in participating school
Exclusion Criteria:
- None.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Health Coaching
1:1 Health coaching with student
|
Child will receive 1:1 coaching with health coach.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child & Youth Resilience Measure - Revised (CYRM-R)
Time Frame: 12 weeks
|
Assessment of a child's resiliency.
Scores range from 17 (low resiliency) to 85 (high resiliency)
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jill L Kaar, PhD, University of Colorado Denver | Anschutz
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 12, 2020
Primary Completion (ACTUAL)
May 31, 2021
Study Completion (ACTUAL)
May 31, 2021
Study Registration Dates
First Submitted
December 16, 2019
First Submitted That Met QC Criteria
December 16, 2019
First Posted (ACTUAL)
December 18, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 6, 2023
Last Update Submitted That Met QC Criteria
February 2, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 19-2602
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Unknown at this time.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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