Resilient Families Open Pilot: Dyadic Resiliency Intervention

NCT06239571 | Active Not Recruiting

• 1 other identifier: 2024P000169
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Parents

Keywords

Neonatal Intensive Care Unit; Parental mental health; Parental relationships

Outcome Measures

Primary Outcomes (3)

• Depression

  Level of depression endorsed on Hospital Anxiety \& Depression Scale and Edinburgh Postnatal Depression Scale, from 0-30 with 30 indicating highest depression

  Baseline to end of intervention (6 weeks)

• Anxiety

  Level of anxiety endorsed on Hospital Anxiety \& Depression Scale, from 0-21 with 21 indicating highest anxiety

  Baseline to end of intervention (6 weeks)

• Posttraumatic Stress

  Level of posttraumatic stress endorsed on Impact of Event Scale-6, from 6-24 with 24 indicating highest posttraumatic stress

  Baseline to end of intervention (6 weeks)

Secondary Outcomes (2)

• Couple relationship functioning

  Baseline to end of intervention (6 weeks)

• Family Impact

  Baseline to end of intervention (6 weeks)

Study Arms (1)

Dyadic Resiliency Intervention

EXPERIMENTAL

All participants will receive the intervention, a brief dyadic resiliency intervention

Behavioral: Resilient Families (R-FAM)

Interventions

Resilient Families (R-FAM) BEHAVIORAL

Dyadic, resiliency intervention that aims to reduce depression, anxiety, and posttraumatic stress among parents of babies in the NICU

Dyadic Resiliency Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02114, United States

Location

Study Officials

• Victoria Grunberg

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: May 8, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 28, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)