PURSUIT: A Technologically Augmented School-based Program to Improve Child Coping and Prevent Substance Use.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PURSUIT.
- Who it may be relevant to
- Registry conditions: Pediatric Pain, Anxiety, Mood, Stress. Basic parameters: 8 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
The study investigator's aims are to:
1. Evaluate the feasibility and acceptability of the PURSUIT online support platform using mixed methods. 2. 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.
Interventions
- Behavioral PURSUIT
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.
Primary outcome measures
- PURSUIT Feasibility-Youth Retention [Time frame: From baseline to post assessment, approximately 8 weeks]
- PURSUIT Feasibility/Acceptability [Time frame: From baseline to post-assessment, approximately 8 weeks.]
Secondary outcome measures (12)
- Changes in pain, as measured by the Pain Visual Analog Scale (VAS) [Time frame: 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.]
- 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.]
- Change in anxiety symptoms, measured using the Screen for Child Anxiety Related Disorders (SCARED) [Time frame: 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.]
- Change in fatigue symptoms; as measured by the PROMIS Pediatric Short Form 10a [Time frame: 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]
- Change in youths' perceived risk of substance use; measured using Monitoring The Future items [Time frame: 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.]
- 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.]
- Change in stress, measured by the PROMIS Pediatric Psychological Stress Experiences 8a [Time frame: From baseline to post-assessment; approximately 8 weeks]
- Patient Global Impression of Change [Time frame: post-assessment; approximately 8 weeks after baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Michigan State University — Grand Rapids
Identifiers
NCT: NCT07266740 · STUDY00011346 · G-2404-153994