Adolescent Surgery Roadmap Feasibility and Acceptability Study
Part of paid clinical trials in Ann Arbor, Michigan.
- Sponsor
- University of Michigan
- Study ID
- NCT06991673
- Status
- Not Yet Recruiting
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Conditions
- Pediatric Surgical Procedures
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- Behavioral Treatment — BEHAVIORALPositive Activity Interventions within Ane-Roadmap App Positive Piggy Bank - Capture happy moments by mentally savoring them, recording details, and depositing them into a "piggy bank". Open it when you need a boost. Gratitude Diary - Write two unique things daily for which you're grateful. Smile as you record them to enhance gratitude. Savoring - Each day, spend 2-3 minutes fully enjoying two positive experiences. Log them for reflection. Pleasant Activity Scheduling - Plan and engage in enjoyable activities at least twice weekly. Treat them as important appointments. Random Acts of Kindness - Perform five intentional kind acts in a day, four for others and one for yourself. Signature Strengths - Use a personal strength in a new way daily and reflect on its impact. Love Letter - Express deep appreciation to a loved one in a heartfelt letter and share it with them. Engaging with Beauty - Keep a log of beautiful moments in nature, art, or human kindness.
Study Details
The goal of this clinical trial is to test the feasibility and acceptability of using a mobile health app, Ane-Roadmap, designed to support adolescents (ages 12-17) undergoing painful surgeries and their caregivers. The main questions it aims to answer are: * Can adolescent surgery patients and their caregivers be successfully enrolled in the study, with at least 40% of those invited choosing to participate? * Will participants actively use the mobile app, completing at least two activities per week for at least half of the study period, either individually and/or as a caregiver-adolescent pair? Participants will: * Use the Ane-Roadmap app during their post-surgery recovery period to complete resilience-building activities aimed at improving wellbeing * Use the app either individually or together as a caregiver-adolescent pair. * Complete surveys regarding risk factors for adverse postsurgical pain outcomes and physical and psychological symptoms experienced postoperatively * Some participants will complete a semi-structured interview in which experiences with the study and intervention activities will be elicited
Key Dates
- Start date
- Jul 31, 2025
- Status verified
- Jun 2025
- Primary completion
- Dec 31, 2029
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Positive Activity Interventions + SurveysIntervention arm participants will complete one of eight positive activities within the Ane-Roadmap App either as individuals or as an adolescent-caregiver team. Positive activities include gratitude journaling, planning positive experiences, savoring, identifying personal strengths, performing acts of kindness, love letters, engaging with beauty, and positive piggy bank. Participants in the intervention group will receive reminders to complete activities as an individual and as an adolescent-caregiver team. Participants will denote with a checkbox whether intervention activities were completed as an individual vs. as an adolescent-caregiver team. Participants in the control arm will have access to the Ane-Roadmap app, however all intervention activities will be turned off. Both control and intervention groups will complete daily and weekly surveys via links embedded within the Roadmap app. Reminders will be sent to participants to complete surveys each day.
- No Intervention: Surveys OnlyControl arm participants will not have access to the positive psychology interventions activities within the Ane-Roadmap app. They will only complete daily and weekly surveys.
Primary Outcome Measure
Recruitment Potential (Feasibility) [ Time Frame: Up to 74 days (60 days post-surgery) ]
Central Contacts
- Sydney Brown, MD PhD734-803-3152
- Emma Wymer, BA734-998-4551
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Michigan Medicine- East Ann Arbor Ambulatory Surgery and Medical Procedures Center | Ann Arbor | Michigan | 48109 | Sydney Brown (PRINCIPAL_INVESTIGATOR) |
| University of Michigan affiliated hospitals | Ann Arbor | Michigan | 48109 | Sydney Brown, MD PhD (PRINCIPAL_INVESTIGATOR) |
| Michigan Medicine- Brighton Center for Specialty Care | Brighton | Michigan | 48116 | Sydney Brown (PRINCIPAL_INVESTIGATOR) |
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