Resilient Families (R-FAM)

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Mass General Brigham

Status and phase

Not yet enrolling
Phase 1

Conditions

Parents

Treatments

Behavioral: Resilient Families (R-FAM)

Study type

Interventional

Funder types

Other

Identifiers

NCT06239571
2024P000169

Details and patient eligibility

About

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).

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Adult parent/legal guardian (and/or their partner) of a baby admitted to the NICU within past week (age ≥ 18)
  • Currently in an intimate relationship and will live with baby after NICU discharge
  • At least one dyad member is emotionally distressed (HADS >7 on depression or anxiety subscale)
  • English fluency/literacy
  • Ability and willingness to participate via live video

Exclusion criteria

  • Baby is expected to pass away (as determined by medical team)
  • Current, untreated psychosis or substance dependence/abuse
  • Current self-report of suicidal ideation

Trial design

10 participants in 1 patient group

Dyadic Resiliency Intervention
Experimental group
Description:
All participants will receive the intervention, a brief dyadic resiliency intervention
Treatment:
Behavioral: Resilient Families (R-FAM)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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