Depression, AnxietyNCT04234425
A Trauma-Informed Approach for Positive Youth Development for Montana Students
A study testing Trauma-Informed Yoga in people with Depression, Anxiety and Adolescent Behavior, run by Montana State University at 1 site in United States.
Trial summary
Given the prevalence of suicide and mental health issues in rural Montana, this project is intended to help mitigate stressors that may contribute to poor behavioral and mental health in high school-aged children. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Adolescent Behavior, Stress
- What is being tested?
- Trauma-Informed Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2019to 22 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Students enrolled in a specific weight training class at predetermined high school in rural Montana
Who cannot join
- Students not enrolled in a specific weight training class at predetermined high school in rural Montana
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trauma-Informed Approach for Positive Youth Development for Montana
Given the prevalence of suicide and mental health issues in rural Montana, this project is intended to help mitigate stressors that may contribute to poor behavioral and mental health in high school-aged children. The immediate goal is to determine viability of a partnership with a rural southwestern Montana school and test the feasibility of a piloted implementation of a trauma-informed yoga intervention to address behavioral health outcomes and positive youth development.
- Conditions
- Depression, Anxiety, Adolescent Behavior, Stress
- Being tested
- Trauma-Informed Yoga
- Medical subject headings
- Depression, Anxiety Disorders, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Informed YogaBehavioural
Trauma-Informed Yoga practice held within a high school weight training class
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 18 high school students in a weight training class will be assigned to this experimental group and will receive the one-hour intervention twice weekly for 8 weeks. Receives: Behavioral: Trauma-Informed Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Cortisol Testing
Students will provide a saliva sample in which cortisol levels will be analyzed through salivary assay kits (through Salimetrics.com). Samples will be collected on the first day of the intervention, halfway through the intervention, and on the last day of the intervention to determine if the intervention has improved stress levels (as indicated by a reduction in cortisol levels). A biostatistician will provide analysis and conclusion of these samples at the conclusion of the study.
Measured: Baseline and 4 weeks (Midpoint)
Secondary outcomes (3)
Generalized Anxiety Disorder-7 Anxiety Scale
This 7 item questionnaire is based on a likert scale of 0 (not at all) to 3 (nearly every day) for items related to anxiety disorders. The lowest score is a zero and the maximum score is a 21. A reduction in score from pre- to post-assessment indicates an improvement in symptomology.
Measured: Baseline and 7 weeks after beginning of intervention
Patient Health Questionnaire for Adolescents
This 9 item questionnaire is designed to evaluate severity of depressive symptoms in adolescents. It is scored on a Likert scale from 0 (not at all) to 3 (nearly every day) on items linked to depression indicators. The minimum score is a 0 and the maximum score is a 27, and a reduction in score from pre- to post-assessment indicates an improvement in symptomology.
Measured: Baseline and 7 weeks after beginning of intervention
Strengths and Difficulties Questionnaire for Ages 11-17 (Overall Score)
This 25 item questionnaire is a brief emotional and behavioral scale for adolescents based on psychological attributes. Items are scored on a Likert scale from 0 (Not True) to 2 (Certainly True). The range in overall scores is 0-40. A reduction in score from pre- to post-assessment indicates an improvement in symptomology/outcomes.
Measured: Baseline and 7 weeks after beginning of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start15 Nov 2019
- Primary completion12 Mar 2020
- Study completion22 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Davis, Montana State University
- Investigators
- Lauren E Davis, Doctoral, Principal investigator, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234425
- Sponsor's protocol ID
- Davis01
- Status last verified
- Dec 2020
- First submitted
- 14 Jan 2020
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trauma-Informed Approach for Positive Youth Development for Montana
- ClinicalTrials.gov ID
- NCT04234425
- Acronym / sponsor ID
- Davis01
- Conditions
- Depression, Anxiety, Adolescent Behavior, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Given the prevalence of suicide and mental health issues in rural Montana, this project is intended to help mitigate stressors that may contribute to poor behavioral and mental health in high school-aged children. The immediate goal is to determine viability of a partnership with a rural southwestern Montana school and test the feasibility of a piloted implementation of a trauma-informed yoga intervention to address behavioral health outcomes and positive youth development.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Trauma-Informed Yoga18 high school students in a weight training class will be assigned to this experimental group and will receive the one-hour intervention twice weekly for 8 weeks. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Students enrolled in a specific weight training class at predetermined high school in rural Montana
Key exclusion criteria (1 listed)
- Students not enrolled in a specific weight training class at predetermined high school in rural Montana
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 |
|---|---|---|
| Trauma-Informed YogaTrauma-Informed Yoga practice held within a high school weight training class | Behavioural | Experimental Group |
Primary outcome
Salivary Cortisol Testing
Time frame: Baseline and 4 weeks (Midpoint)
Students will provide a saliva sample in which cortisol levels will be analyzed through salivary assay kits (through Salimetrics.com). Samples will be collected on the first day of the intervention, halfway through the intervention, and on the last day of the intervention to determine if the intervention has improved stress levels (as indicated by a reduction in cortisol levels). A biostatistician will provide analysis and conclusion of these samples at the conclusion of the study.
3 secondary outcomes
Generalized Anxiety Disorder-7 Anxiety Scale
Time frame: Baseline and 7 weeks after beginning of intervention
Patient Health Questionnaire for Adolescents
Time frame: Baseline and 7 weeks after beginning of intervention
Strengths and Difficulties Questionnaire for Ages 11-17 (Overall Score)
Time frame: Baseline and 7 weeks after beginning of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lauren E Davis, Doctoral principal investigator
Montana State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-Informed Yoga in people with Depression, Anxiety and Adolescent Behavior, run by Montana State University 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 5 Jan 2021. 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?
Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Salivary Cortisol Testing (time frame: Baseline and 4 weeks (Midpoint)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2021.