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| ID | Type | Description | Link |
|---|---|---|---|
| G-2404-153994 | Other Grant/Funding Number | Michigan Health Endowment Fund |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PURSUIT Self-Management Portal | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PURSUIT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PURSUIT Feasibility-Youth Retention | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in pain, as measured by the Pain Visual Analog Scale (VAS) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Youth Engagement | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natoshia R Cunningham, PhD | Contact | 845-662-6198 | natoshia@msu.edu | |
| Jocelyn Zuckerman | Contact | zucker32@msu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan State University | Grand Rapids | Michigan | 49503 | United States |
We will not publicly share to protect participant identities but de-identified data may be made available upon reasonable request.
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All youth enrolled in the study will be given access to the online self-management platform.
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Masking does not apply to this study.
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| Change in functional disability, measured using the Functional Disability Inventory (FDI) |
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 | 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) | 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 | 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 | 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 | 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 |
| Change in youths' perceived risk of substance use; measured using Monitoring The Future items | 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) | 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) | 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 | 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 |
| Patient Global Impression of Change | 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). | post-assessment; approximately 8 weeks after 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 | 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 |
| Youth School Attendance | 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 |
| Symptom status and program motivation | 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. | baseline |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064419 | Chemically-Induced Disorders |
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