Michigan State University
Grand Rapids, Michigan, 49503, United States
NCT Number: NCT07266740
The study investigators aim to test an online support platform for Michigan youth aged 8-18 years enrolled in elementary, middle, or high school and their parent/caregiver. The online support platform will be hosted on the Computerized Intervention Authoring System (CIAS) 3.0 and will provide evidence-based cognitive behavioral coping skills for physical (pain) and mental (stress, mood) health symptoms, with additional substance use prevention content for youth aged 12 and older. Evaluations will occur at baseline and then a post assessment approximately 8 weeks later.
Trial opening soon.
Get Notified8 year–18 year
All sexes
Interventional
Not applicable
Grand Rapids, Michigan, 49503, United States
The study investigator's aims are to:
Consented youth will complete a baseline assessment (week 1), and then will use the PURSUIT online platform (expected duration is 6 week), and complete a post assessment (week 8).
Within the PURSUIT platform, all youth will have access to tools teaching cognitive-behavioral strategies for managing mood, anxiety, stress, and physical pain. Youth aged 12 and older will have access to additional content presenting cognitive-behavioral strategies for reducing the risk of substance use.
Youth will provide data on their symptoms (e.g thoughts, mood, behaviors, sleep, pain, and stress) at baseline and post assessment. A caregiver will report on the child's demographics, adverse childhood experience (ACE) exposure, school performance/attendance and their own mood. At post-assessment, the youth will also be asked to take part in a brief, semi-structured interview regarding their experiences with PURSUIT.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PURSUIT is an online self-management platform for youth aged 8-18 and one caregiver that provides cognitive-behavioral coping skills for physical and mental health symptoms, plus substance use prevention content for youth aged 12 and older.
Time frame: From baseline to post assessment, approximately 8 weeks
The percentage of youth who complete a post-assessment measure, relative to those who complete a baseline assessment.
Time frame: From baseline to post-assessment, approximately 8 weeks.
Youth will complete a brief, semi-structured interview following a six-week period of engagement with the online self-management portal to assess the feasibility ("Do you think you will be able to integrate these skills into your schedule with school/work?") and acceptability of PURSUIT.
Time frame: From baseline to post-assessment, approximately 8 weeks.
Youth will report their average pain intensity over the past two weeks using a Visual Analog Scale (VAS). Responses range from 0 (no pain) to 10 (worst imaginable pain), with ratings ≥ 3 indicating moderate pain.
Time frame: From baseline to post-assessment, approximately 8 weeks.
The 15-item FDI assesses youths' difficulty performing tasks across home, school, recreational, and social settings over the "past few days" due to physical symptoms. Items are rated from 0 ("no trouble") to 4 ("impossible") and summed, yielding total scores of 0-60 with scores ≥7 suggesting greater than minimal disability
Time frame: From baseline to post-assessment, approximately 8 weeks.
The UCLA Reaction Index for DSM-5 Brief Screening Form is an 11-item measure of how often youth experienced psychological stress and physiological reactivity due to internal or external trauma reminders, intrusive trauma-related memories, avoidance of internal and external reminders of trauma, emotional dysregulation, attention issues, feelings of detachment, and sleep disturbance over the past month. Items are scored from zero (none of the time) to four (most of the time) and summed; scores of 11-20 suggest mild PTSD symptoms, while scores ≥21 are indicative of potential PTSD. We adapted this measure to not query the type of traumatic exposure experienced by youth. It will only be completed by those who endorse exposure (yes/no) to a frightening or upsetting event.
Time frame: From baseline to post-assessment, approximately 8 weeks.
The 41-item Screen for Child Anxiety Related Disorders (SCARED) assesses past 3-month anxiety symptoms. Items are scored on a 3-point Likert-style scale (0 = not true or hardly ever true, 2=very true or often true), and summed to yield total scores of 0-82 with higher scores indicating greater anxiety and scores ≥25 suggesting clinical significance.
Time frame: From baseline to post-assessment, approximately 8 weeks.
Youth will report the frequency (1=never, 5=almost always) of past-week depressive symptoms (e.g., sadness, loneliness) using the eight-item PROMIS Pediatric Depressive Symptoms Short Form 8a. Raw summed scores (range 8 to 40) are converted to T-scores (mean 50, standard deviation 10), with T-scores >55 suggesting mild or higher symptoms.
Time frame: From baseline to post-assessment, approximately 8 weeks.
Past week fatigue symptoms will be self-reported by youth using the 10-item PROMIS Pediatric Short Form. Items ("Being tired made it hard for me to play or go out with my friends as much as I'd like") are rated on a 5-point Likert-style scale (1=never, 5=almost always) and summed in to total scores, which are converted into T-scores (>55 suggesting at least mild symptoms).
Time frame: From baseline to post-assessment; approximately 8 weeks
The frequency (1=never, 5=almost always) with which youth experienced sleep disturbance symptoms (e.g., trouble falling or staying asleep) in the past week will be assessed using the eight-item PROMIS Pediatric Sleep Disturbance Short Form. T-scores (>55 indicative of mild or greater symptoms) will be derived from summed raw scores.
Time frame: From baseline through post-assessment; approximately 8 weeks.
Youth age 12 and older will report how risky (1= No Risk, 4=Great Risk) they perceive different cigarette, cannabis, alcohol, or vaping use behaviors (e.g., occasional versus regular use) using 12 items from the 2023 Monitoring the Future (MTF) study. MTF is an ongoing longitudinal panel study conducted by the University of Michigan that includes annual surveys of nationally representative samples of 8th, 10,th and 12th grade youth.
Time frame: From baseline through post-assessment; approximately 8 weeks.
The frequency (never, once or twice, monthly, weekly or more often) of past-year nicotine, alcohol, cannabis, and other substance use behaviors will be assessed for youth 12 years and older using the youth-reported Screening to Brief Intervention (S2BI)
Time frame: From baseline to post-assessment, approximately 8 weeks.
The DASS21 depression, anxiety, and stress on a scale of 0-63 with 0 indicating low levels of these feelings, and 63 indicating high levels. This measure will only be completed by caregivers.
Time frame: From baseline to post-assessment; approximately 8 weeks
Youth will report how often (1=never, 5=almost always) they experienced feelings of stress over the past week using the eight-item PROMIS Psychological Stress Experiences-Short Form 8a. As per other PROMIS short forms, summed scores are converted to T-scores.
Time frame: post-assessment; approximately 8 weeks after baseline
A single-item measure completed by the child and caregiver that assesses perceived overall change in the child's status since completing the intervention. Scores range from 1 (Very Much Improved) to 7 (Very Much Worse).
Time frame: From baseline to post-assessment, approximately 8 weeks
The percent of youth who complete at least one activity within the platform, relative to those who complete baseline assessments.
Time frame: Baseline
Youth's lifetime exposure to nine ACEs (e.g., violence, household dysfunction) will be reported by caregivers (if age <18) using items adapted from the National Survey of Children's Health.
Time frame: Baseline
Parents/caregivers will report youths' age, sex at birth, racial and ethnic identities, household income, health insurance status/type, and their own highest level of education at baseline.
Time frame: From baseline to post-assessment; approximately 8 weeks
Parent/caregivers will report the frequency with which their child misses or is late to school due to physical and/or mental health symptoms over the past month at baseline and after engaging with the self-management platform
Time frame: baseline
A brief intake questionnaire assessing whether participants experience pain, worries or sad feelings, and stress at baseline and their reasons for participating in the program.
Contact information is provided by the study sponsor or research team.
Jocelyn Zuckerman
CONTACT
Natoshia R Cunningham, PhD
CONTACT
Michigan State University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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