NCT07266740

Brief 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 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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
May 2026Oct 2026

First Submitted

Initial submission to the registry

November 24, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

November 24, 2025

Last Update Submit

May 5, 2026

Conditions

Keywords

Cognitive-behavioralSchoolPediatricsStressPainAnxietyMoodSubstance use

Outcome Measures

Primary Outcomes (2)

  • 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.

Secondary Outcomes (11)

  • Changes in pain, as measured by the Pain Visual Analog Scale (VAS)

    From baseline to post-assessment, approximately 8 weeks.

  • Change in functional disability, measured using the Functional Disability Inventory (FDI)

    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

    From baseline to post-assessment, approximately 8 weeks.

  • Change in anxiety symptoms, measured using the Screen for Child Anxiety Related Disorders (SCARED)

    From baseline to post-assessment, approximately 8 weeks.

  • Change in depressive symptoms, measured using the PROMIS Pediatric Short Form 8a

    From baseline to post-assessment, approximately 8 weeks.

  • +6 more secondary outcomes

Other Outcomes (4)

  • Youth Engagement

    From baseline to post-assessment, approximately 8 weeks

  • Adverse Childhood Experiences (ACEs)

    Baseline

  • Family Demographic Information

    Baseline

  • +1 more other outcomes

Study Arms (1)

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.

Behavioral: PURSUIT

Interventions

PURSUITBEHAVIORAL

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.

PURSUIT Self-Management Portal

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged eight to 18 years
  • Enrolled in a Michigan elementary, middle, or high school

You may not qualify if:

  • Age under 8
  • Age over 18 years
  • Non-enrollment in A Michigan school.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Anxiety DisordersPainSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsChemically-Induced Disorders

Central Study Contacts

Natoshia R Cunningham, PhD

CONTACT

Jocelyn Zuckerman

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Masking does not apply to this study.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: All youth enrolled in the study will be given access to the online self-management platform.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 5, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

We will not publicly share to protect participant identities but de-identified data may be made available upon reasonable request.

Locations