ParentsR-FAMNCT06239571
Resilient Families Open Pilot: Dyadic Resiliency Intervention
A study testing Resilient Families (R-FAM) in people with Parents, run by Massachusetts General Hospital at 1 site in United States.
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). 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)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 (HADS >7 on depression or anxiety subscale)
- 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.
About this study
Official title: Resilient Families: A Dyadic Resiliency Intervention for Parents of Babies in the NICU
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).
Read the 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
- Being tested
- Resilient Families (R-FAM)
- Keywords
- Neonatal Intensive Care Unit, Parental mental health, Parental relationships
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilient Families (R-FAM)Behavioural
Dyadic, resiliency intervention that aims to reduce depression, anxiety, and posttraumatic stress among parents of babies in the NICU
| Study group | Role | What they receive |
|---|---|---|
| Dyadic Resiliency Intervention | Experimental | All participants will receive the intervention, a brief dyadic resiliency intervention Receives: Behavioral: Resilient Families (R-FAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Level of depression endorsed on Hospital Anxiety \& Depression Scale and Edinburgh Postnatal Depression Scale, from 0-30 with 30 indicating highest depression
Measured: Baseline to end of intervention (6 weeks)
Anxiety
Level of anxiety endorsed on Hospital Anxiety \& Depression Scale, from 0-21 with 21 indicating highest anxiety
Measured: 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: 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: 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 posted2 Feb 2024
- Study start8 May 2025
- Primary completion1 Apr 2026
- Study completion15 Apr 2026
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria A. Grunberg, PhD, Massachusetts General Hospital
- Investigators
- Victoria Grunberg, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239571
- Sponsor's protocol ID
- 2024P000169
- Acronym
- R-FAM
- Status last verified
- Jul 2026
- First submitted
- 25 Jan 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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
- Resilient Families: A Dyadic Resiliency Intervention for Parents of Babies in the NICU
- ClinicalTrials.gov ID
- NCT06239571
- Acronym / sponsor ID
- R-FAM / 2024P000169
- Conditions
- Parents
- Keywords
- Neonatal Intensive Care Unit, Parental mental health, Parental relationships
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 2 Feb 2024 (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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dyadic Resiliency Intervention | Experimental | Behavioral: Resilient Families (R-FAM)All participants will receive the intervention, a brief dyadic resiliency intervention |
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 (HADS >7 on depression or anxiety subscale)
- 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)Dyadic, resiliency intervention that aims to reduce depression, anxiety, and posttraumatic stress among parents of babies in the NICU | Behavioural | Dyadic Resiliency Intervention |
Primary outcome
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
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
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
2 secondary outcomes
Couple relationship functioning
Time frame: Baseline to end of intervention (6 weeks)
Family Impact
Time frame: Baseline to end of intervention (6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Parents
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Enrolling by invitation
MIO-CPP to Improve the Well-being, Permanency, and Safety Outcomes for Young Children at Risk of or in Out-of-home Placement in Philadelphia and Bucks Counties, and Affected by Maternal Substance Use
Substance Use Disorders, Parent-Child Relations
RecruitingObservational study
Pediatric Research in the Outpatient Setting CoHort
Factors Associated With a Child's Development of Interaction and Communication Skills and Measures Taken, Reported Stress Level of the Parents of a Newborn and Measures Taken
Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Active, not recruiting
The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
Maternal Morbidity and Mortality, Health Disparities
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. This study is not recruiting at the moment.
Victoria Grunberg 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) 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (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.