RECRUITING

SBIR/ STTR Family Check-up Online

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 Family Check-Up Online, a digital health intervention, was designed to improve child mental health through family-centered intervention. The Family Check-Up is grounded in over 25 years of evidence-based research and has been shown to improve child mental health and behavior including depression and conduct problems. The investigators were supported by an SBIR Phase I award (R43MH132191) to evaluate the feasibility and acceptability of the digital health product in schools and to adapt the product based on findings of that work. Findings from that project suggested the model is a good fit for schools, with school providers stating a need for family-centered interventions that target child behavior and mental health, but with few resources or evidence-based programs available. The research team received feedback that suggests the model should be evaluated as both an uncoached version and coached version, delivered with provider support. In the current project, the investigators plan to continue work in schools to develop the model for commercialization, including understanding the process for embedding the FCU Online into current student support systems and implementation factors that lead to maintenance of the model in schools. The investigators plan to conduct a hybrid type 2 effectiveness-implementation trial to evaluate the effectiveness of the FCU Online when delivered by real world providers. Thirty providers (N=600 students/families) will be randomly assigned to receive training in the FCU Online coached vs. uncoached models. The research team will then evaluate outcomes including family relationships, parenting skills, and child mental health and behavior. The investigators predict that the FCU Online will improve child mental health and behavior, and will test for moderators such as provider training and child baseline risk. Findings will have implications for commercialization of the product in schools and implementation of the model in a range of different school settings.

Official Title

A Digital Health Technology to Prevent Family Violence and Improve Child Mental Health

Quick Facts

Study Start:2025-01-20
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06876246

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * A caregiver must have a child between the ages of 11 and 14;
  2. * the caregiver must be the parent or legal guardian of the youth;
  3. * the caregiver must have a smartphone with text messaging capability and access to email; and
  4. * the youth must be identified by school providers as needing or being eligible for Tier 2 or Tier 3 supports or services.
  1. * the caregiver is unable to read in either English or Spanish; or
  2. * the family is already participating in another study of the University of Oregon's Prevention Science Institute.

Contacts and Locations

Study Contact

Allison S Caruthers, PhD
CONTACT
503-412-3770
ascaru@uoregon.edu
Anne M Mauricio, PhD
CONTACT
541-346-3630
amariem@uoregon.edu

Principal Investigator

Anne M Mauricio, PhD
PRINCIPAL_INVESTIGATOR
University of Oregon
Lisa A Reiter, PhD
PRINCIPAL_INVESTIGATOR
Northwest Prevention Science
Elizabeth A Stormshak, PhD
PRINCIPAL_INVESTIGATOR
Northwest Prevention Science

Study Locations (Sites)

Prevention Science Institute
Eugene, Oregon, 97403
United States

Collaborators and Investigators

Sponsor: University of Oregon

  • Anne M Mauricio, PhD, PRINCIPAL_INVESTIGATOR, University of Oregon
  • Lisa A Reiter, PhD, PRINCIPAL_INVESTIGATOR, Northwest Prevention Science
  • Elizabeth A Stormshak, PhD, PRINCIPAL_INVESTIGATOR, Northwest Prevention Science

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 Date2025-01-20
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2025-01-20
Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

  • digital health
  • implementation science
  • mental health
  • family intervention
  • school-based intervention

Additional Relevant MeSH Terms

  • Mental Health
  • Parenting Stress
  • Academic Achievement
  • Parenting Skills
  • Behavior Problems