NICU-to-Home Dyadic Support for Very Preterm Infants and Families (MN-SPEEDI)

September 9, 2026 updated by: University of Minnesota

Providing NICU-to-Home Dyadic Support for Very Preterm Infants and Their Families: A Feasibility Study

This feasibility study will evaluate delivery of the Supporting Play Exploration and Early Development Intervention after neonatal intensive care unit discharge for very preterm infants and their families.

Parent-preterm infant dyads will be assigned to homebased SPEEDI, telehealth SPEEDI, or a control group. SPEEDI is an early developmental intervention focused on supporting parent confidence, interpretation of infant behavioral cues, and parent-infant relationship building through developmentally appropriate play.

The study will assess feasibility of initiating SPEEDI 1 to 5 days after NICU discharge, including recruitment, retention, session attendance, activity log completion, intervention adherence, and delivery differences between homebased and telehealth SPEEDI. Family experiences and provider perspectives on strengths and barriers to SPEEDI implementation will also be evaluated.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Very preterm infants and their families may experience challenges during the transition from the neonatal intensive care unit to home. Early intervention during this transition may support parent-infant relationships, infant development, and family confidence.

This feasibility study will evaluate whether the Supporting Play Exploration and Early Development Intervention can be initiated 1 to 5 days after NICU discharge and delivered in either homebased or telehealth contexts. The study will enroll 40 parent-preterm infant dyads from the University of Minnesota Masonic Children's Hospital NICU. Infants will have been born at less than 32 weeks gestation and discharged from the NICU between 35 and 44 weeks postmenstrual age.

After baseline assessment, parent-infant dyads will be assigned to homebased SPEEDI, telehealth SPEEDI, or control. Families in the homebased and telehealth groups will receive 10 intervention sessions across 15 weeks. SPEEDI is grounded in positive parent-infant relationship building and supports parents in interpreting infant behavioral cues and stress signs, increasing parenting confidence, and engaging infants in developmentally appropriate therapeutic play.

Assessments will occur at Visit 1, 1 to 5 days after NICU discharge; Visit 2, 15 weeks after baseline; and Visit 3, 30 weeks after baseline. Study assessments include parent questionnaires, parent-infant interaction videos scored with the Emotional Availability Scale, infant motor and developmental assessments, and infant activity measurement using the Motor Assessment of Infants with Jumpsuit at Visit 3.

The primary focus of the study is feasibility rather than efficacy. Feasibility measures include recruitment, dropout rate, intervention and assessment attendance, parent activity log completion, SPEEDI adherence, and differentiation between telehealth and homebased delivery. Qualitative interviews with families and Part C Early Intervention providers will be used to identify experiences, strengths, and barriers relevant to future implementation studies.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Corri Stuyvenberg, PT, DPT, PhD
  • Phone Number: 952-818-1309
  • Email: stuyv006@umn.edu

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota Masonic Children's Hospital
      • Minneapolis, Minnesota, United States, 55414
        • Masonic Institute for the Developing Brain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Written informed consent obtained from participant and ability for participant to comply with study requirements
  • Stated willingness to comply with all study procedures, including consenting parent attendance at all study assessment and intervention visits
  • Stated willingness to comply with assignment to the homebased, telehealth, or control group
  • Infant gestational age of less than 32 weeks at birth
  • Infant hospitalized for more than 28 days following preterm birth
  • Infant discharged from the NICU between 35 and 44 weeks postmenstrual age
  • Consenting parent plans to live in Minnesota for a minimum of 6 months from recruitment
  • Consenting parent must be able to understand and speak English
  • Consenting parent age 18 years or older

Exclusion Criteria:

  • Infant has a genetic syndrome or metabolic disorder known to be progressive or to have developmental consequences
  • Infant has a condition that is not compatible with life
  • Prisoners with infants in the NICU
  • Pregnant women/persons
  • Fetuses
  • Neonates
  • Non-English speakers
  • Employees of the researcher
  • Students of the researcher

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Homebased SPEEDI
Parent-preterm infant dyads assigned to this arm will receive SPEEDI in the family home. The intervention will include 10 sessions over 15 weeks after baseline, beginning within 1 week after Visit 1.
Behavioral: Homebased SPEEDI
The SPEEDI intervention is an early developmental intervention grounded in positive parent-infant relationship building. Homebased SPEEDI will be delivered in the family home over 10 sessions across 15 weeks after baseline. The intervention supports parents in interpreting infant behavioral cues and stress signs, building parent confidence, and engaging the infant in developmentally appropriate therapeutic play.
Other Names:
  • Supporting Play Exploration and Early Development Intervention
Experimental: Telehealth SPEEDI
Parent-preterm infant dyads assigned to this arm will receive SPEEDI via telehealth. The intervention will include 10 sessions over 15 weeks after baseline, beginning within 1 week after Visit 1.
Behavioral: Telehealth SPEEDI
Telehealth SPEEDI will deliver the SPEEDI intervention remotely over 10 sessions across 15 weeks after baseline. Sessions will support parents in interpreting infant cues, increasing confidence, and engaging the infant in developmentally appropriate play using telehealth-based coaching.
Other Names:
  • Supporting Play Exploration and Early Development Intervention via Telehealth
No Intervention: Control
Parent-preterm infant dyads assigned to this arm will complete study assessments at baseline, 15 weeks after baseline, and 30 weeks after baseline, but will not receive the SPEEDI intervention as part of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Initiating SPEEDI After NICU Discharge
Time Frame: Baseline through 30 weeks after baseline
Feasibility will be assessed using recruitment of 40 dyads within 6 to 9 months, dropout rate less than 10%, intervention session attendance of 80%, assessment session attendance of 90%, parent activity log completion of 80%, SPEEDI interventionist and parent adherence to key protocol components of 90%, and less than 10% differentiation between telehealth and homebased SPEEDI components.
Baseline through 30 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family Experience With SPEEDI
Time Frame: Between 15 weeks and 30 weeks after baseline
Qualitative interviews will be conducted with families receiving homebased or telehealth SPEEDI to assess family experiences, including perceived strengths, barriers, benefits, harms, confidence interacting with the infant, and confidence reading infant cues.
Between 15 weeks and 30 weeks after baseline
Provider-Reported Strengths and Barriers to SPEEDI Implementation
Time Frame: During study participation, through study completion
Qualitative interviews or focus groups with Part C Early Intervention providers will assess perceived strengths and barriers to implementing SPEEDI in urban and rural settings.
During study participation, through study completion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Parent-Infant Emotional Availability
Time Frame: Baseline, 15 weeks after baseline, and 30 weeks after baseline
Low-efficacy outcome: Change in parent-infant emotional availability will be assessed using the Emotional Availability Scale from video-recorded parent-infant interactions. This outcome will be evaluated as an exploratory/low-efficacy outcome because the primary focus of this feasibility study is feasibility, not efficacy.
Baseline, 15 weeks after baseline, and 30 weeks after baseline
Change in Infant Motor Performance
Time Frame: Baseline and 15 weeks after baseline
Low-efficacy outcome: Infant motor performance will be assessed using the Test of Infant Motor Performance.
Baseline and 15 weeks after baseline
Change in Infant Developmental Function
Time Frame: 15 weeks after baseline and 30 weeks after baseline
Low-efficacy outcome: Infant developmental function will be assessed using the Bayley Scales of Infant and Toddler Development-4.
15 weeks after baseline and 30 weeks after baseline
Infant Movement and Posture at Follow-up
Time Frame: 30 weeks after baseline
Low-efficacy outcome: Infant movement and posture will be assessed using the Motor Assessment of Infants with Jumpsuit during a 30-minute data collection session at the follow-up visit.
30 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Corri Stuyvenberg, PT, DPT, PhD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

September 2, 2026

First Submitted That Met QC Criteria

September 9, 2026

First Posted (Actual)

September 15, 2026

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTSI-34485

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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