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OpenTrials
Completed

NCT Number: NCT06239571

Resilient Families Open Pilot: Dyadic Resiliency Intervention

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mass General Brigham

Boston, Massachusetts, 02114, United States

About this study

The investigators aim to conduct an open pilot trial of the R-FAM program (Resilient Families) with NICU parents (up to N = 6 dyads) followed by an optional brief exit interview. The investigators will determine if the feasibility, acceptability, and fidelity of the program meet a priori benchmarks. The investigators also hope to establish preliminary efficacy that the program reduces parental emotional distress and other study outcomes described in sections below. The investigators will use qualitative data to optimize the intervention and study procedures for future trials.

This Open Pilot trial will include 6 sessions with a clinical psychologist. The intervention will aim to improve coping skills, communication, and stress management. Participants will learn evidence-based skills (e.g., mindfulness, dialectics, problem-solving) to reduce risk for emotional distress.

The primary outcomes for the open pilot will be the feasibility, acceptability, and fidelity of the R-FAM program. Preliminary effectiveness outcomes will also be examined, as in primary and secondary targets and exploratory outcomes (e.g., emotional distress, couple satisfaction, and family impact).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resilient Families (R-FAM)

Behavioral

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

Primary outcomes

  1. Depression

    Time frame: Baseline to end of intervention (6 weeks)

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

  2. Anxiety

    Time frame: Baseline to end of intervention (6 weeks)

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

  3. Posttraumatic Stress

    Time frame: Baseline to end of intervention (6 weeks)

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

Secondary outcomes

  1. Couple relationship functioning

    Time frame: Baseline to end of intervention (6 weeks)

    Couple satisfaction as reported on Couple Satisfaction Index, from 0-21 with 21 indicating highest couple satisfaction

  2. Family Impact

    Time frame: Baseline to end of intervention (6 weeks)

    Impact of child's illness as reported on Family Impact Scale, Revised, from 0-75 with 75 indicating lowest impact on family

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: R-FAM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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