Resilient Families

Not Applicable

Recruiting

• Conditions: Parents
• Interventions: Behavioral: Resilient Families (R-FAM)

• Registration Number: NCT06239571
• Lead Sponsor: Massachusetts General Hospital

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

Not available

Study Timeline

• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-02-02
• Status Verified: 2025-05
• Study Start: 2025-05-08
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13
• Primary Completion: 2027-04-01
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dyadic Resiliency Intervention	Resilient Families (R-FAM)	All participants will receive the intervention, a brief dyadic resiliency intervention

Primary Outcome Measures

Name	Time	Method
Depression	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
Anxiety	Baseline to end of intervention (6 weeks)	Level of anxiety endorsed on Hospital Anxiety \& Depression Scale, from 0-21 with 21 indicating highest anxiety
Posttraumatic Stress	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 Outcome Measures

Name	Time	Method
Couple relationship functioning	Baseline to end of intervention (6 weeks)	Couple satisfaction as reported on Couple Satisfaction Index, from 0-21 with 21 indicating highest couple satisfaction
Family Impact	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

Trial Locations

Locations (1)

Mass General Brigham; 🇺🇸 Boston, Massachusetts, United States