Resilient Families Open Pilot: Dyadic Resiliency Intervention

NCT ID: NCT06239571

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-08
• Study Completion Date: 2028-03-31

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).

Detailed Description

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).

Conditions

Parents

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dyadic Resiliency Intervention

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

Group Type: EXPERIMENTAL

Resilient Families (R-FAM)

Intervention Type: BEHAVIORAL

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

Interventions

Resilient Families (R-FAM)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Victoria A. Grunberg, PhD

Clinical Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victoria Grunberg

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Mass General Brigham

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2024P000169

Identifier Type: -

Identifier Source: org_study_id