- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07266740
PURSUIT: A Technologically Augmented School-based Program to Improve Child Coping and Prevent Substance Use.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study investigator's aims are to:
- Evaluate the feasibility and acceptability of the PURSUIT online support platform using mixed methods.
- Explore the impact of PURSUIT on youth's physical (pain) and mental health (stress, anxiety, mood, perceived risk of substance use) symptoms at post assessment.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Natoshia R Cunningham, PhD
- Phone Number: 845-662-6198
- Email: natoshia@msu.edu
Study Contact Backup
- Name: Jocelyn Zuckerman
- Email: zucker32@msu.edu
Study Locations
-
-
Michigan
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Grand Rapids, Michigan, United States, 49503
- Michigan State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged eight to 18 years
- Enrolled in a Michigan elementary, middle, or high school
Exclusion Criteria:
- Age under 8
- Age over 18 years
- Non-enrollment in A Michigan school.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PURSUIT Self-Management Portal
All youth enrolled in the study will have access to an online self-management platform, hosted by the Computerized Intervention Authoring System (CIAS).
The self-management platform comprises evidence-based cognitive-behavioral psycho-education and skills broadly applicable to physical (pain) and mental (stress, mood) health symptoms.
Youth aged twelve and older will have access to content related to preventing substance use.
Materials include instructional videos, handouts, and worksheets.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PURSUIT Feasibility-Youth Retention
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.
|
From baseline to post assessment, approximately 8 weeks
|
|
PURSUIT Feasibility/Acceptability
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.
|
From baseline to post-assessment, approximately 8 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in pain, as measured by the Pain Visual Analog Scale (VAS)
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.
|
From baseline to post-assessment, approximately 8 weeks.
|
|
Change in functional disability, measured using the Functional Disability Inventory (FDI)
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
|
From baseline to post-assessment, approximately 8 weeks.
|
|
Changes in post-traumatic stress disorder symptoms (PTSD), measured using the UCLA Reaction Index for DSM-5 Brief Screening Form
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.
|
From baseline to post-assessment, approximately 8 weeks.
|
|
Change in anxiety symptoms, measured using the Screen for Child Anxiety Related Disorders (SCARED)
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.
|
From baseline to post-assessment, approximately 8 weeks.
|
|
Change in depressive symptoms, measured using the PROMIS Pediatric Short Form 8a
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.
|
From baseline to post-assessment, approximately 8 weeks.
|
|
Change in fatigue symptoms; as measured by the PROMIS Pediatric Short Form 10a
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).
|
From baseline to post-assessment, approximately 8 weeks.
|
|
Change in sleep disturbance symptoms, measured using the PROMIS Pediatric Sleep Disturbance Short Form 8a
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.
|
From baseline to post-assessment; approximately 8 weeks
|
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Change in youths' perceived risk of substance use; measured using Monitoring The Future items
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.
|
From baseline through post-assessment; approximately 8 weeks.
|
|
Change in youth's substance use behaviors; assessed using the Screening to Brief Intervention (S2B1)
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)
|
From baseline through post-assessment; approximately 8 weeks.
|
|
Changes in caregivers' depression, anxiety, and stress as measured by the Depression Anxiety and Stress Scales 21 (DASS21)
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.
|
From baseline to post-assessment, approximately 8 weeks.
|
|
Change in stress, measured by the PROMIS Pediatric Psychological Stress Experiences 8a
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.
|
From baseline to post-assessment; approximately 8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Youth Engagement
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.
|
From baseline to post-assessment, approximately 8 weeks
|
|
Adverse Childhood Experiences (ACEs)
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.
|
Baseline
|
|
Family Demographic Information
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.
|
Baseline
|
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Youth School Attendance
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
|
From baseline to post-assessment; approximately 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00011346
- G-2404-153994 (Other Grant/Funding Number: Michigan Health Endowment Fund)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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