ParentsR-FAMNCT07383948
Resilient Families Feasibility Trial
A study testing Resilient Families (R-FAM) and Educational Resources & Program in people with Parents, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this study is to 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parents
- What is being tested?
- Resilient Families (R-FAM) and Educational Resources & Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 (GAD>=10 or PHQ >= 10)
- English fluency/literacy
- Ability and willingness to participate via live video
Who cannot join
- Baby is expected to pass away (as determined by medical team)
- Current, untreated psychosis or substance dependence/abuse
- Current self-report of suicidal ideation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mass General Brigham
Boston, Massachusetts, 02114
Victoria A Grunberg, PhD, 617-643-4133, vgrunberg@mgh.harvard.edu
Cindy Liu, PhD, CHLIU@BWH.HARVARD.EDU
About this study
Official title: Enhancing Parental Well-being in the NICU
The goal of this study is to 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, the investigators are developing a randomized control trial where patients will be randomized to either the R-FAM condition or a minimally enhanced usual control (MEUC), which includes resources on parent mental health and coping in the NICU.
Read the detailed description
The investigators aim to conduct a pilot feasibility randomized clinical trial (RCT) of R-FAM (Resilient Families) with NICU parents (up to N = 70 dyads) followed by a 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 and data from the R-FAM open pilot to optimize the intervention and study procedures for future trials.
The investigators will conduct a single-blinded randomized clinical trial comparing the feasibility and acceptability of Resilient Families (R-FAM)-a resiliency intervention-with a one session educational program (minimally enhanced usual control) for parental couples ("dyads") of babies in the NICU. The investigators will also explore preliminary changes in outcomes and mechanisms to inform future trials. See Figure 1 for iterative development of R-FAM (the study is in years 3 and 4).
After enrollment, participants will be randomized to either the "Resilient Families" intervention or to the educational program (control). Dyads will be randomly assigned in a 1:1 ratio to intervention or control to ensure comparability between groups. The randomization schedule will be prepared using permuted blocks of size 2 and 4 by the unblinded study statistician and implemented in REDCap. All subjects will be given baseline psychological and behavioral assessments that will assess depression, anxiety, PTSD symptoms, and other psychological constructs.
- Conditions
- Parents
- Being tested
- Resilient Families (R-FAM), Educational Resources & Program
- Keywords
- Neonatal Intensive Care Unit, Parent Mental Health, Parent relationships
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilient Families (R-FAM)Other
R-FAM is a resiliency intervention for couples with an infant admitted to the NICU. Parents will complete 6 guided sessions with a clinical psychologist that cover topics such as managing stress, staying in the present, and coping with uncertainty. Through these sessions, parents will learn skills to manage the "emotional roller-coaster" of the NICU, cope with stress, and connect with each other.
Educational Resources & ProgramOther
Parents will receive educational resources on how to cope with and adjust to the NICU stay.
| Study group | Role | What they receive |
|---|---|---|
| R-FAM Intervention | Other | A resiliency based intervention that includes 6-sessions with a clinician to help couples cope with the uncertainty and stress of the NICU admission. Receives: Other: Resilient Families (R-FAM) |
| Educational Program | Active comparator | Participants will receive educational resources about adjusting to the NICU and coping with their stay. Receives: Other: Educational Resources & Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Level of anxiety endorsed on Hospital Anxiety \& Depression Scale, from 0-21 with 21 indicating highest anxiety
Measured: Time Frame: Baseline to end of intervention (6 weeks)
Depression
Level of depression endorsed on Hospital Anxiety \& Depression Scale, from 0-21, with 21 indicating highest depression.
Measured: Time Frame: 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
Measured: Time Frame: Baseline to end of intervention (6 weeks)
Secondary outcomes (2)
Couple relationship functioning
Couple satisfaction as reported on Couple Satisfaction Index, from 0-21 with 21 indicating highest couple satisfaction
Measured: Time Frame: Baseline to end of intervention (6 weeks)
Family Impact
Impact of child's illness as reported on Family Impact Scale, Revised, from 0-75 with 75 indicating lowest impact on family
Measured: Baseline to end of intervention (6 weeks)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Apr 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Victoria A. Grunberg, PhD, Massachusetts General Hospital
- Investigators
- Victoria A Grunberg, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383948
- Sponsor's protocol ID
- 2025P003422
- Other IDs
- 5K23HD110597-03
- Acronym
- R-FAM
- Status last verified
- Jul 2026
- First submitted
- 22 Jan 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Parental Well-being in the NICU
- ClinicalTrials.gov ID
- NCT07383948
- Acronym / sponsor ID
- R-FAM / 2025P003422
- Conditions
- Parents
- Keywords
- Neonatal Intensive Care Unit, Parent Mental Health, Parent relationships
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to 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, the investigators are developing a randomized control trial where patients will be randomized to either the R-FAM condition or a minimally enhanced usual control (MEUC), which includes resources on parent mental health and coping in the NICU.
Detailed description
The investigators aim to conduct a pilot feasibility randomized clinical trial (RCT) of R-FAM (Resilient Families) with NICU parents (up to N = 70 dyads) followed by a 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 and data from the R-FAM open pilot to optimize the intervention and study procedures for future trials.
The investigators will conduct a single-blinded randomized clinical trial comparing the feasibility and acceptability of Resilient Families (R-FAM)-a resiliency intervention-with a one session educational program (minimally enhanced usual control) for parental couples ("dyads") of babies in the NICU. The investigators will also explore preliminary changes in outcomes and mechanisms to inform future trials. See Figure 1 for iterative development of R-FAM (the study is in years 3 and 4).
After enrollment, participants will be randomized to either the "Resilient Families" intervention or to the educational program (control). Dyads will be randomly assigned in a 1:1 ratio to intervention or control to ensure comparability between groups. The randomization schedule will be prepared using permuted blocks of size 2 and 4 by the unblinded study statistician and implemented in REDCap. All subjects will be given baseline psychological and behavioral assessments that will assess depression, anxiety, PTSD symptoms, and other psychological constructs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R-FAM Intervention | Other | Other: Resilient Families (R-FAM)A resiliency based intervention that includes 6-sessions with a clinician to help couples cope with the uncertainty and stress of the NICU admission. |
| Educational Program | Active comparator | Other: Educational Resources & ProgramParticipants will receive educational resources about adjusting to the NICU and coping with their stay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (GAD>=10 or PHQ >= 10)
- English fluency/literacy
- Ability and willingness to participate via live video
Key exclusion criteria (3 listed)
- Baby is expected to pass away (as determined by medical team)
- Current, untreated psychosis or substance dependence/abuse
- Current self-report of suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resilient Families (R-FAM)R-FAM is a resiliency intervention for couples with an infant admitted to the NICU. Parents will complete 6 guided sessions with a clinical psychologist that cover topics such as managing stress, staying in the present, and coping with uncertainty. Through these sessions, parents will learn skills to manage the "emotional roller-coaster" of the NICU, cope with stress, and connect with each other. | Other | R-FAM Intervention |
| Educational Resources & ProgramParents will receive educational resources on how to cope with and adjust to the NICU stay. | Other | Educational Program |
Primary outcome
Anxiety
Time frame: 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
Depression
Time frame: Time Frame: Baseline to end of intervention (6 weeks)
Level of depression endorsed on Hospital Anxiety \& Depression Scale, from 0-21, with 21 indicating highest depression.
Posttraumatic Stress
Time frame: 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
2 secondary outcomes
Couple relationship functioning
Time frame: Time Frame: Baseline to end of intervention (6 weeks)
Family Impact
Time frame: Baseline to end of intervention (6 weeks)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victoria A Grunberg, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilient Families (R-FAM) and Educational Resources & Program in people with Parents, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria A Grunberg, PhD (617-643-4133, vgrunberg@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Time Frame: Baseline to end of intervention (6 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.