RECRUITING

Evaluation of the SafeSpace App Intervention

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to evaluate the impact of SafeSpace Sexual Health App, an innovative sexual health promotion program focused on reducing sexual risk factors and promoting sexual and reproductive health and wellbeing among young people assigned female or intersex at birth, particularly Black and/or Latine youth, LGBTQ+ youth, youth in states with high teen birth rates and youth who live in rural communities. This study utilizes a two-arm randomized control trial design to measure impacts of receiving the SafeSpace Sexual Health program compared to receiving a similar-length control app program, SafeSpace General Health that focuses on general health. The investigators will ask participants to: * Keep the SafeSpace app downloaded to their device and visit the app regularly over the course of 10 weeks. * Provide contact information. * Receive and open app push notifications for 10 weeks (up to 3 per week). * Complete 3 online surveys over a year: baseline, short-term follow-up (10 weeks after baseline), and long-term follow up (9 months after short-term follow-up). * Receive occasional text messages from the study team.

Official Title

Evaluation of the SafeSpace App Intervention

Quick Facts

Study Start:2023-06-12
Study Completion:2026-09-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06043596

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must be assigned female or intersex at birth
  2. * Participants must be youth in the U.S. (14-18 years old)
  3. * Participants must have daily access to an iPhone
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Elizabeth Cook, MSPH
CONTACT
240-223-9323
ecook@childtrends.org
Jennifer Manlove, PhD
CONTACT
240-223-9262
jmanlove@childtrends.org

Principal Investigator

Jennifer Manlove, PhD
STUDY_DIRECTOR
Child Trends
Elizabeth L Cook, MSPH
STUDY_DIRECTOR
Child Trends
Riley Steiner, PhD
PRINCIPAL_INVESTIGATOR
Power to Decide

Study Locations (Sites)

Child Trends
Bethesda, Maryland, 20814
United States

Collaborators and Investigators

Sponsor: Child Trends

  • Jennifer Manlove, PhD, STUDY_DIRECTOR, Child Trends
  • Elizabeth L Cook, MSPH, STUDY_DIRECTOR, Child Trends
  • Riley Steiner, PhD, PRINCIPAL_INVESTIGATOR, Power to Decide

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-12
Study Completion Date2026-09-29

Study Record Updates

Study Start Date2023-06-12
Study Completion Date2026-09-29

Terms related to this study

Additional Relevant MeSH Terms

  • Health Behavior
  • Health Care Utilization
  • Unprotected Sex
  • Sexually Transmitted Infections