N/A
N=86
Promoting Healthy Lifestyle Behaviors
Behavioral / Psychiatric Disorder · Lifestyle, Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05675020 ↗Enrolled (actual)
86
Serious AEs
—
Results posted
Oct 2024
Primary outcome: Primary: Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions. — 33; 44; 56; 33 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zoom Intervention (Behavioral)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Florida State University
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions. |
33; 44; 56; 33; 44; 67 | — |
| PRIMARY Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions |
5; 5; 4; 5; 5; 6 | — |
Summary
This study's purpose is to identify factors that may aid in answering the clinical question: Among adolescents 12-17 years old who are diagnosed with a mental health condition(s), does a family-based educational intervention improve healthy lifestyle knowledge and behaviors, including nutrition, PA, screen time, and sleep? The specific aims are to: Aim 1: To educate adolescents with mental health conditions and their family members about ways to improve healthy lifestyle behaviors. Aim 2: To evaluate an increase in knowledge on healthy lifestyle behaviors after a 45-minute online education session. Aim 3: To evaluate an increase in healthy lifestyle behaviors after the intervention.
This project utilizes a one-group pretest-posttest design study for 30 adolescents (aged 12-17 years) diagnosed with a mental health condition(s) and their parent/legal guardian. This project will implement best practices to promote healthy lifestyle knowledge and behaviors to adolescents and their parent(s)/legal guardian(s). This will be a 45-minute educational presentation delivered via Zoom. Participants will have option to select between 2-3 dates and times for educational presentation. The investigators will compare the effects of an educational program on healthy lifestyle knowledge and behaviors pre-and post-program (after one month) via a REDCap survey for the adolescent and their parent/legal guardian. The survey will utilize an adapted version of the 2021 National Youth Risk Behavior Survey (YRBS) and the 2020 National Survey of Children's Health (NSCH-T3). The analysis of this project will compare changes in healthy lifestyle knowledge and behaviors using a paired t-test. The educational presentation will be recorded and emailed to participants within 1 week of intervention to re-watch/review.
Eligibility Criteria
- Adolescents, 12-17 years old, with a clinical diagnosis of a mental health condition(s) and their parent/legal guardian.
- Examples of eligible diagnosed mental health conditions include major depressive disorder (MDD), generalized anxiety disorder (GAD), attention-deficit disorder (ADD)/ attention deficit hyperactivity disorder (ADHD), bipolar disorder (BPD).
- Adolescents that score below 13 on the World Health Organization (Five) Well-Being Index survey or if the adolescent has answered 0 to 1 to any of the five items, they will not be allowed to complete the REDCap survey or participate in the project unless they are currently enrolled in outpatient mental health services (Ex: counseling, therapy, partial hospitalization).
- Parent(s)/legal guardian(s), 18 years old or older, live with adolescents diagnosed with a mental health condition(s)
Inclusion Criteria
- Individuals who are not yet adults (Adolescents 12-17 years old)
- With diagnosed mental health condition (ex: Depression, Anxiety, ADD/ADHD) more than one year ago.
- Adolescent eligibility determined with WHO-5 screening prior to pre-intervention survey. o Parent(s)/legal guardian(s), 18 years old or order, live with adolescents diagnosed with mental health condition(s)
- Be able to read/write in English
Exclusion Criteria
- Children 18 years old
- Children 12-17 that are wards of the state or any other agency, institution, or entity
- Adolescent scoring <13 and not currently enrolled in mental health services, or if the adolescent has answered 0 to 1 to any of the five items, on the WHO-5, and not currently enrolled in mental health services.
- Female participants that report they are pregnant before or after the start of the study will be excluded from the study.
- Parent(s)/legal guardian(s) < 18 years old
- Non-legal guardians
Data sourced from ClinicalTrials.gov (NCT05675020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.