Summary
The goal of this study is to find the best way to help participants and families manage the stress of facing a serious illness and be better able to "bounce back" or be resilient after a difficult situation. Participants will take part in the "Promoting Resilience in Stress Management" PRISM program, which is designed to provide skills to change or improve the impact of stress in everyday life. The name of the intervention used in this research study is: -PRISM (a mobile app program comprised of 6 sessions of skills-based, manualized resilience education)
Conditions
Stress, Anxiety
Recruitment Status
Recruiting
Detailed Description
In this sequential, multiple assignment, randomized trial participants will be randomly selected to participate in PRISM program sessions with a trained research coach either by text or by video sessions, or participants will use the PRISM mobile app program in a self-guided way. Randomization means the group participants are placed in will be decided by chance. All groups will continue to receive all the same care from primary medical, social work, and other care teams. In this two-stage study, participants will be randomly assigned to either the "app-only" (20% chance), "text" (40% chance) or "video" (40% chance) groups for the first stage. In the second stage, participants may be re-randomized again to the "app-only," or "text," groups, or will be referred to a specialty psychosocial support, social worker or counselor, based on responses to questionnaires. Participants randomized to the "app-only" group in the first stage will not be re-randomized. The research study procedures include screening for eligibility and completion of questionnaires. Participation in this research study is expected to last for up to 6 months. It is expected about 325 people will take part in this research study. The National Institute for Health (NIH) is funding this research study.
Eligibility Criteria
Participants that have completed their main cancer-directed therapy at one of the study sites affiliated centers who meet all the eligibility criteria will be eligible for participation in this study.
Inclusion Criteria:
All genders ≥ 12 and ≤ 25 years of age at baseline
Participant is able to speak English or Spanish language (for PRISM sessions)
Participant is able to read English or Spanish language (for completion of surveys)
Participant is cognitively able to participate in PRISM sessions and complete written questionnaires and surveys, as judged by the site investigator
Intervention
Intervention Type
Intervention Name
Behavioral
PRISM Program Video Coach
Behavioral
PRISM Program Text Coach
Behavioral
mPRISM Program App
Phase
Not Applicable
Gender
All
Min Age
12 Years
Max Age
25 Years
Download Date
October 31, 2023
Principal Investigator
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
Primary Contact Information
abbyr_rosenberg@dfci.harvard.edu
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: