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New program aims to ease NICU Parents' stress

NCT ID NCT07383948

Symptom relief Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study tests a program called Resilient Families (R-FAM) for parents of babies in the Neonatal Intensive Care Unit (NICU). The program includes 6 guided sessions with a psychologist to help parents manage stress, stay present, and cope with uncertainty. The goal is to see if the program is feasible and acceptable, and if it can reduce emotional distress and improve relationships among parents. 50 parents in a relationship will be randomly assigned to either the R-FAM program or receive educational resources only.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Resilient Families (R-FAM) program: 6 guided sessions with a psychologist to learn stress management and coping skills
What this could lead to
If it works, this could provide a practical way to support parents during a stressful NICU stay, reducing anxiety and depression.
What could go wrong
This is a small, early feasibility study with only 50 participants, so results may not apply to all parents. The program requires time and commitment, and may not help everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (GAD\>=10 or PHQ \>= 10) * 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parents

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mass General Brigham

    RECRUITING

    Boston, Massachusetts, 02114, United States

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