Resilient Families

Parents Clinical Trial

— R-FAM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06239571
• Other study ID #: 2024P000169
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 1, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: March 31, 2028
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parents

Intervention

Behavioral:
• Resilient Families (R-FAM)
Dyadic, resiliency intervention that aims to reduce depression, anxiety, and posttraumatic stress among parents of babies in the NICU

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Couple relationship functioning	Couple satisfaction as reported on Couple Satisfaction Index, from 0-21 with 21 indicating highest couple satisfaction	Baseline to end of intervention (6 weeks)
Secondary	Family Impact	Impact of child's illness as reported on Family Impact Scale, Revised, from 0-75 with 75 indicating lowest impact on family	Baseline to end of intervention (6 weeks)