1. Lessons Learned in Implementing Interventions in School-based Settings Bernadette Mazurek Melnyk, PhD, RN, CPNP/PMHNP, FAAN Associate Vice President for Health Promotion University Chief Wellness Officer Dean and Professor, College of Nursing Professor of Pediatrics and Psychiatry The Ohio State University Funding Support NIH/The National Institute of Nursing Research R01NR012171

2. Purpose of this Presentation To share lessons learned in conducting randomized controlled trials in school-based settings

3. Significance of the Problem Currently, 17% of adolescents are overweight (gender and age specific BMI at or above the 85 th %) or obese (BMI at or above the 95 th %); as high as 34% in Hispanic teens

4. Significance of the Problem One in 4 adolescents has a mental health problem and less than 25% receive any treatment Hispanic and White teens are more likely to report depression and feelings of worthlessness There is a higher incidence of mental health disorders and school problems in overweight/obese teens

5. Purpose of the Study The aim of our clinical trial is to evaluate the efficacy of our COPE/Healthy Lifestyle TEEN (Thinking, Emotions, Exercise and Nutrition) Program on the healthy lifestyle behaviors, mental health and academic outcomes of 779 high school 14-16 year old adolescents Study outcomes include healthy lifestyle behaviors, depressive symptoms, anxiety, social skills, academic performance and body mass index Proposed mediators include teen healthy lifestyle beliefs and perceived difficulty to engaging in healthy behaviors

6. Components of the 15-Session COPE Healthy Lifestyles TEEN Program 7 Sessions of cognitive-behavioral skills building Nutrition and physical activity education 20 minutes of physical activity in each session

7. Cognitive Behavioral Skills Building in COPE: Consists of Cognitive Restructuring, Problem Solving and Behavioral Change The thinking/feeling/behaving triangle Feeling Thinking Behaving

8. Teen Demographics Characteristic TotalCOPEControl (n = 493)(n = 270)(n = 223) MSDM M Age 14.550.7314.590.7314.510.72 TotalCOPEControl n%n%n% GenderFemale27255.1715155.9312154.26 Male22144.8311944.0710245.74 Grade Level*+9th grade38377.6920676.3017779.37 10th grade6312.784416.30198.52 11th grade438.72186.672511.21 12th grade4.812.742.90 * Chi square +p<.05

9. Teen Demographics Characteristic TotalCOPEControl n%n%n% Race*+American Native132.6482.9652.24 Asian173.4551.85125.38 Black5310.75238.523013.45 White275.48103.70177.62 Hispanic38077.0822181.8515971.30 Other3.6131.110.00 BMI*+Underweight61.220.0062.69 PercentileNormal26353.3515055.5611350.67 Overweight10020.285118.894921.97 Obese12425.156925.565524.66 * Chi square +p<.05

10. Parent Demographics Characteristic TotalCOPEControl (n = 287) (n = 161)(n = 126) MSDM M Age 39.787.2940.177.1639.287.45 TotalCOPEControl n%n%n% Gender*+Female24886.4114891.9310079.37 Male3913.59138.072620.63 Race*+American Native 62.1042.4821.59 Asian72.4531.8643.17 Black248.3995.591511.90 White206.9953.111511.90 Hispanic22679.0213885.718869.84 Other31.0521.2410.79 Not Reported10.3500.0010.79 * Chi square +p<.01

11. Parent Demographics Characteristic TotalCOPEControl (n = 287) (n = 161)(n = 126) n%n%n% Marital StatusMarried16356.799357.767055.56 Unmarried12342.866842.245543.65 Not Reported10.3500.0010.79 Education*+Less than High School 13346.348552.804838.10 High School Graduate 7626.484226.093426.98 Some College5719.862414.913326.19 College Graduate196.6295.59107.94 Not Reported20.7010.6210.79 * Chi square +p<.05

12. Preliminary Findings Post-intervention, COPE Teens versus Attention Control Teens had significantly: Greater steps per day Lower mean BMI Higher average scores on three social skills subscales: (a) cooperation (b) assertion, and (c) academic competence Higher health course grades Less alcohol and less marijuana use

13. Preliminary Findings 6 Months Post-intervention, COPE Teens versus Attention Control Teens had significantly: Lower mean BMI Lower proportion of overweight

14. Lessons Learned Persist through the character-builders in pursuit of schools that will permit you to conduct research with their students Carefully consider who will deliver the intervention; if it is the teachers, they will need excellent training Use incentives and enlist teacher help in the recruitment of teens and parents; consider sending consents home to the parents through the teens Gain teacher buy-in and input; provide preferred incentives

15. Lessons Learned Determine the best method of random assignment Assess intervention fidelity carefully Prevent attrition and missing data Determine best method for analysis; Control for key variables that could impact outcomes Incorporate the “so what” outcome factors in your design (outcomes that will matter to schools)!

16. In the world of school-based research, nothing is terminal. Everything is transitional What looks like the end of the road will turn out to be a bend in the road!

17. Contact Information Bernadette Melnyk Melnyk.15@osu.edu