PURSUIT: A Technologically Augmented School-based Program to Improve Child Coping and Prevent Substance Use.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorMichigan State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged eight to 18 years

Enrolled in a Michigan elementary, middle, or high school

Disqualifiers

Age under 8

Age over 18 years

Non-enrollment in A Michigan school.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: PURSUIT Self-Management PortalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PURSUIT Feasibility-Youth Retention

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
2

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.

Time frame
From baseline to post-assessment, approximately 8 weeks.

Secondary outcomes

1

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.

Time frame
From baseline to post-assessment, approximately 8 weeks.
2

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

Time frame
From baseline to post-assessment, approximately 8 weeks.
3

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.

Time frame
From baseline to post-assessment, approximately 8 weeks.
4

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.

Time frame
From baseline to post-assessment, approximately 8 weeks.

Other outcomes

1

Youth Engagement

The percent of youth who complete at least one activity within the platform, relative to those who complete baseline assessments.

Time frame
From baseline to post-assessment, approximately 8 weeks
2

Adverse Childhood Experiences (ACEs)

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
3

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.

Time frame
Baseline
4

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

Time frame
From baseline to post-assessment; approximately 8 weeks

Sponsors and contacts

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