Trial Outcomes & Findings for A Trauma-Informed Approach for Positive Youth Development for Montana Students (NCT NCT04234425)

Last Updated: 2021-01-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

Baseline and 4 weeks (Midpoint)

Results posted on

2021-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Group 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. Trauma-Informed Yoga: Trauma-Informed Yoga practice held within a high school weight training class
Overall Study STARTED	18
Overall Study Midpoint-Week 4	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trauma-Informed Approach for Positive Youth Development for Montana Students

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Group n=18 Participants 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. Trauma-Informed Yoga: Trauma-Informed Yoga practice held within a high school weight training class
Age, Categorical <=18 years	18 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	17 years STANDARD_DEVIATION 0.83 • n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	16 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	16 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	18 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 4 weeks (Midpoint)

Population: 18 students in a weight training class in a rural Montana high school

Outcome measures

Outcome measures
Measure	Experimental Group-Midpoint Data (4 Weeks) n=18 Participants 18 high school students in a weight training class (one student less than baseline due to attrition)	Experimental Group-Baseline Data n=18 Participants 18 high school students in a weight training class
Salivary Cortisol Testing	0.245 ug/dl Standard Deviation 0.1356	0.3088 ug/dl Standard Deviation 0.1552

SECONDARY outcome

Timeframe: Baseline and 7 weeks after beginning of intervention

Population: High School Students in rural Montana

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.

Outcome measures

Outcome measures
Measure	Experimental Group-Midpoint Data (4 Weeks) n=18 Participants 18 high school students in a weight training class (one student less than baseline due to attrition)	Experimental Group-Baseline Data 18 high school students in a weight training class
Generalized Anxiety Disorder-7 Anxiety Scale Post Survey Results	4.20 score on a scale Standard Deviation 5.36	—
Generalized Anxiety Disorder-7 Anxiety Scale Pre-Survey Results	7.33 score on a scale Standard Deviation 5.44	—

SECONDARY outcome

Timeframe: Baseline and 7 weeks after beginning of intervention

Population: high school students in rural Montana

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.

Outcome measures

Outcome measures
Measure	Experimental Group-Midpoint Data (4 Weeks) n=18 Participants 18 high school students in a weight training class (one student less than baseline due to attrition)	Experimental Group-Baseline Data 18 high school students in a weight training class
Patient Health Questionnaire for Adolescents Post-Survey Results	4.20 score on a scale Standard Deviation 7.06	—
Patient Health Questionnaire for Adolescents Pre-Survey Results	6.72 score on a scale Standard Deviation 4.42	—

SECONDARY outcome

Timeframe: Baseline and 7 weeks after beginning of intervention

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.

Outcome measures

Outcome measures
Measure	Experimental Group-Midpoint Data (4 Weeks) n=18 Participants 18 high school students in a weight training class (one student less than baseline due to attrition)	Experimental Group-Baseline Data 18 high school students in a weight training class
Strengths and Difficulties Questionnaire for Ages 11-17 (Overall Score) Post-Survey Overall Score	20.47 score on a scale Standard Deviation 7.33	—
Strengths and Difficulties Questionnaire for Ages 11-17 (Overall Score) Pre-Survey Overall Score	23.72 score on a scale Standard Deviation 7.48	—

Adverse Events

Experimental Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lauren Davis

Montana State University

Phone: 8287736328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place