Pediatric PainNCT07266740
PURSUIT: A Technologically Augmented School-based Program to Improve Child Coping and Prevent Substance Use.
A study testing PURSUIT in people with Pediatric Pain and Anxiety, run by Michigan State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Pain, Anxiety, Mood
- What is being tested?
- PURSUIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged eight to 18 years
- Enrolled in a Michigan elementary, middle, or high school
Who cannot join
- Age under 8
- Age over 18 years
- Non-enrollment in A Michigan school.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jocelyn Zuckerman contact
United States1 site
Michigan State University
Grand Rapids, Michigan, 49503
About this study
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.
Read the 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.
- Conditions
- Pediatric Pain, Anxiety, Mood, Stress, Feasibility Studies, Acceptability
- Being tested
- PURSUIT
- Keywords
- Cognitive-behavioral, School, Pediatrics, Stress, Pain, Anxiety, Mood, Substance use
- Medical subject headings
- Anxiety Disorders, Pain, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PURSUITBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PURSUIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PURSUIT Feasibility-Youth Retention
The percentage of youth who complete a post-assessment measure, relative to those who complete a baseline assessment.
Measured: 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.
Measured: From baseline to post-assessment, approximately 8 weeks.
Secondary outcomes (12)
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.
Measured: From baseline to post-assessment, approximately 8 weeks.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: post-assessment; approximately 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study startNov 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All youth enrolled in the study will be given access to the online self-management platform.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natoshia Cunningham, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266740
- Sponsor's protocol ID
- STUDY00011346
- Other IDs
- G-2404-153994
- Status last verified
- May 2026
- First submitted
- 24 Nov 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not publicly share to protect participant identities but de-identified data may be made available upon reasonable request.