RECRUITING

Resilient Families

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 is to develop, refine, and test the feasibility and acceptability of a dyadic, resiliency intervention ("Resilient Families;" R-FAM) that aims to reduce emotional distress and improve relationships among parents in the Neonatal Intensive Care Unit (NICU). To achieve this goal, my aims are three-fold: (1) develop R-FAM using stakeholder input from interviews with parent dyads and focus groups with NICU staff; (2) optimize R-FAM through an open pilot with pre/post assessments and exit interviews; and (3) test R-FAM for feasibility and acceptability through a randomized clinical trial of R-FAM compared with a minimally enhanced usual control (MEUC).

Official Title

Resilient Families: A Dyadic Resiliency Intervention for Parents of Babies in the NICU

Quick Facts

Study Start:2025-05-08
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06239571

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. * Adult parent/legal guardian (and/or their partner) of a baby admitted to the NICU within past week (age ≥ 18)
  2. * Currently in an intimate relationship and will live with baby after NICU discharge
  3. * At least one dyad member is emotionally distressed (HADS \>7 on depression or anxiety subscale)
  4. * English fluency/literacy
  5. * Ability and willingness to participate via live video
  1. * Baby is expected to pass away (as determined by medical team)
  2. * Current, untreated psychosis or substance dependence/abuse
  3. * Current self-report of suicidal ideation

Contacts and Locations

Study Contact

Grunberg, PhD
CONTACT
617-643-4133
vgrunberg@mgh.harvard.edu

Study Locations (Sites)

Mass General Brigham
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

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 Date2025-05-08
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2025-05-08
Study Completion Date2028-03-31

Terms related to this study

Keywords Provided by Researchers

  • Neonatal Intensive Care Unit
  • Parental mental health
  • Parental relationships

Additional Relevant MeSH Terms

  • Parents