Mental Health Wellness 1NCT04202913
Building Resilience for Healthy Kids
A study testing Coaching in people with Mental Health Wellness 1, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 867 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children in participating school
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eagleview Middle School
Colorado Springs, Colorado, 80919
About this study
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.
Read the 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.
- Conditions
- Mental Health Wellness 1
- Being tested
- Coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoachingBehavioural
Child will receive 1:1 coaching with health coach.
| Study group | Role | What they receive |
|---|---|---|
| Health Coaching | Experimental | 1:1 Health coaching with student Receives: Behavioral: Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child & Youth Resilience Measure - Revised (CYRM-R)
Assessment of a child's resiliency. Scores range from 17 (low resiliency) to 85 (high resiliency)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start12 Jan 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 867 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill L Kaar, PhD, Principal investigator, University of Colorado Denver | Anschutz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202913
- Sponsor's protocol ID
- 19-2602
- Status last verified
- Sep 2024
- First submitted
- 16 Dec 2019
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Unknown at this time.
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.
PubMed 33665468Lee 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.
PubMed 32959670
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Resilience for Healthy Kids
- ClinicalTrials.gov ID
- NCT04202913
- Acronym / sponsor ID
- 19-2602
- Conditions
- Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 867 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 12 Jan 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Coaching | Experimental | Behavioral: Coaching1:1 Health coaching with student |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children in participating school
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoachingChild will receive 1:1 coaching with health coach. | Behavioural | Health Coaching |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Derived from this study: PubMed 33665468Lee 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.
- Derived from this study: PubMed 32959670Lee 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.
- Individual participant dataSharing planned: No. Unknown at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill L Kaar, PhD principal investigator
University of Colorado Denver | Anschutz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching in people with Mental Health Wellness 1, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child & Youth Resilience Measure - Revised (CYRM-R) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04202913, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024; AzTrials last refreshed its copy on 1 Nov 2026.