Resilient Families (R-FAM)

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

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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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)