RECRUITING

Family Spirit Strengths

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

This project addresses the disproportionate morbidity and mortality associated with mental and behavioral health problems in American Indian and Alaska Native communities. Access to culturally competent and effective behavioral health services is limited in many of these communities. The investigators aim to address this gap by testing the effectiveness of a trans-diagnostic secondary prevention program, Family Spirit Strengths (FSS) that can be embedded within home visiting services. The FSS program is a skills-based program that incorporates elements of evidence-based practice, the Common Elements Treatment Approach (CETA), and materials informed and developed based on an Indigenous advisory group. The FSS program aims to help participants build self-efficacy and coping skills, as well as build stronger connections to others, the participants' community, and cultural resources. The investigators will use a randomized controlled trial, whereby half of the participants will receive FSS and the other half will receive an evidence-based nutrition education program. The investigators' study is grounded in participatory processes and led by a team of Indigenous and allied researchers.

Official Title

Family Spirit Strengths

Quick Facts

Study Start:2023-04-20
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05836090

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
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Self-identify as female; and
  2. * Pregnant or be a primary caregiver of a child that is 24 months or younger; and
  3. * 14 years or older at time of enrollment; and
  4. * Report a family history of high-risk substance use and/or report high-risk levels of personal substance use; and
  5. * Have elevated symptoms of depression and/or anxiety and/or risk of substance use disorder; and
  6. * Be part of the service population of one of the participating sites.
  1. * Profound disability that limits the ability to participate in assessments or interventions; and
  2. * Unlikely to be residing in or near the research service area for the next 6 months.

Contacts and Locations

Study Contact

Emily Haroz, PhD
CONTACT
410-449-0051
eharoz1@jhu.edu
Leonela Nelson, MPH
CONTACT
505-368- 4234
lnelso32@jhu.edu

Principal Investigator

Emily Haroz
PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health

Study Locations (Sites)

Johns Hopkins Center for Indigenous Health
Chinle, Arizona, 86503
United States
Pokagon Health Services
Pokagon, Michigan, 49047
United States
Johns Hopkins Center For Indigenous Health
Shiprock, New Mexico, 87420
United States

Collaborators and Investigators

Sponsor: Johns Hopkins Bloomberg School of Public Health

  • Emily Haroz, PRINCIPAL_INVESTIGATOR, Johns Hopkins Bloomberg School of Public Health

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 Date2023-04-20
Study Completion Date2028-12

Study Record Updates

Study Start Date2023-04-20
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

  • Depressive Symptoms
  • Anxiety Disorders and Symptoms
  • Substance Use
  • Mental Health Issue