Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health (INSPIRE)

January 27, 2026 updated by: Umeå University

Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health (INSPIRE)

Research problem and specific questions More than 1000 very preterm infants (< 32 weeks) are born every year in Sweden. They are at high risk of neurodevelopmental disabilities and mental illness throughout the lifespan.

The overall purpose is to develop and evaluate a novel e-health intervention aimed at improving neurodevelopment (cognitive, motor, feeding, language, socio-emotional) of very preterm infants by supporting responsive parenting behaviours.

The primary research question is whether the intervention improves child neurodevelopment up to 2 years.

Further research questions relate to the emotional availability of parents and children, parental stress and overall experience as well as effects on health inequalities and gender effects.

Data and method Using a multi-professional approach, the study team have developed a post-discharge "Intervention for Neurodevelopmental Support in Preterm Infants using Responsive parenting and E-health" (INSPIRE). Parents of very preterm infants will be included in the program at hospital discharge and will receive the intervention in 18 sessions over a two year period.

The study team have assessed feasibility and refined the intervention in a pilot study including 9 families. This autumn, a randomized clinical trial will be performed to evaluate efficiency: Families will be randomized to the INSPIRE program or standard care. Follow-up and assessment of children (and parents) across a range of crucial domains will be performed up to at least 2 years of age.

Societal relevance and utilisation The project will be the first in the world to use a digital e-health solution with video interaction to deliver a post discharge parental support intervention to parents of very preterm infants. The project has great potential to reduce the risk of cognitive impairment, behavioral problems, mental illness and eating disorders in these high risk children, as well as improving mental health and well-being in the parents. Parents of preterm infants are involved as co-creators in developing and evaluating the program.

Plan for project realization Currently, there is no similar post-discharge program available. Based on the results, the study team aim to implement a sustainable, nationwide, post-discharge e-health intervention program to improve health in very preterm-born children and their parents, which will also reduce health inequality by ensuring the availability of high-quality support to families living far away from highly specialized health care facilities

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

176

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

Study Locations

  • Sweden
    • Dalarna County
      • Falun, Dalarna County, Sweden, 791 82
        • Recruiting
        • Falu County Hospital
    • Jämtland Härjedalen
      • Östersund, Jämtland Härjedalen, Sweden, 831 83
        • Recruiting
        • Östersund hospital
    • Norrbotten County
      • Södra Sunderbyn, Norrbotten County, Sweden, 954 42
        • Recruiting
        • Sunderby Hospital
    • Värmland County
      • Karlstad, Värmland County, Sweden, 651 85
        • Recruiting
        • Karlstad Hospital
    • Västerbotten County
      • Umeå, Västerbotten County, Sweden, 90185
        • Recruiting
        • Umeå University Hospital
        • Contact:
          • Malin C Bergman Papworth, PhD student
          • Phone Number: +46730438397
    • Västernorrland County
      • Sundsvall, Västernorrland County, Sweden, 856 43
        • Recruiting
        • Sundsvall Hospital
    • Örebro County
      • Örebro, Örebro County, Sweden, 701 15
        • Recruiting
        • Örebro University Hospital

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:

* Infant born before 32 GV, or with birth weight under 1500 gr.

Exclusion Criteria:

  • Parent(s) younger than 18 ya.
  • Chromosomal abnormalities, congenital syndromes that may affect the child's development.
  • Parents unable to understand Swedish.
  • Parents with severe mental illness or a physical medical condition requiring extensive inpatient care.
  • Families without a stable living situation, such as parental substance abuse, homelessness, or family living under threat of deportation from Sweden.
  • Families that have previously participated in the INSPIRE study or the INSPIRE pilot study.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Controll group
Standard care
Other: INSPIRE-intervention
Intervention group, recieving the INSPIRE-intervention
Behavioral: Neurodevelopmental support
The Intervention for Neurodevelopmental Support in Preterm Infants using Responsive parenting and E-health (INSPIRE) aims to support the infant's neurodevelopment by supporting the parents to develop a responsive approach. The intervention will enhance the infant's social and environmental interactions, focusing on developing both the infant's and parent's strengths, seeking opportunities instead of problems in behaviour, enhancing mutually satisfying interaction and parental empowerment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bayley Scales of Infant Development (BSID IV)
Time Frame: 24 months corrected age
Bayley Scales of Infant Development (BSID IV) is a test administered by a psychologist for assessment of general neurodevelopment (cognitive, language and motor) at 24 months corrected age (primary outcome)
24 months corrected age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alberta infant motor scale (AIMS)
Time Frame: 6 months corrected age.
Alberta infant motor scale is a test performed by a physiotherapist, based on live observation or a video recording of the infant. We will use video recordings.
6 months corrected age.
Peabody Developmental Motor Scales (PDMS-2)
Time Frame: 24 months corrected age.
Peabody Developmental Motor Scales (PDMS-2) is a test, administered by a physiotherapist, to assess motor function.
24 months corrected age.
Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI IV)
Time Frame: 5,5 years of age
Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI IV) is a test performed by a psychologist for assessment of cognitive development at 5.5 years of age.
5,5 years of age
Movement ABC
Time Frame: 5,5 years of age
Movement ABC is a test administered by a physiotherapist for assessment of motor development at 5.5 years of age.
5,5 years of age
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: 24 months corrected age, 36 months of age and 5,5 years of age
Strengths and Difficulties Questionnaire (SDQ) is a parental questionnaire for assessment of behavioural problems
24 months corrected age, 36 months of age and 5,5 years of age
The Infant Toddler Checklist (ITC)
Time Frame: 18 months corrected age
The Infant Toddler Checklist (ITC) is a questionnaire/method to assess early language development
18 months corrected age
The MacArthur-Bates Communicative Development Inventories (MB-CDIs)
Time Frame: 12 and 18 months corrected age.
The MacArthur-Bates Communicative Development Inventories (MB-CDIs) is a questionnaire/method to assess early language development.
12 and 18 months corrected age.
"Jollerobservation"
Time Frame: 12 months corrected age.
"Jollerobservation" is a Swedish standardised protocol for observation of babbling. The observation is performed by a speech- and language pathologist.
12 months corrected age.
The Montreal Children's Hospital Feeding Scale
Time Frame: 12 months corrected age.
The Montreal Children's Hospital Feeding Scale are a questionnaire that will be used for assessment of feeding development.
12 months corrected age.
The Emotional Availability Scale (EAS)
Time Frame: 12 months corrected age and 24 months corrected age.
The Emotional Availability Scale (EAS) is an observational coding system to assess emotional availability during caregiver-infant interactions regarding both the parent and the child
12 months corrected age and 24 months corrected age.
The Parental Reflective Functioning Questionnaire (PRFQ)
Time Frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.
The Parental Reflective Functioning Questionnaire (PRFQ) will be used to assess parents reflective functioning regarding their child's emotional needs
At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.
Modified Checklist for Autism in Toddlers (M-CHAT
Time Frame: 24 months corrected age
Modified Checklist for Autism in Toddlers (M-CHAT) is a parental questionnaire for assessment of early signs of autism
24 months corrected age
The Reynell Developmental Language Scales IV (RDLS IV)
Time Frame: 36 months of age.
The Reynell Developmental Language Scales IV (RDLS IV) will be used for detailed assessment of language development.
36 months of age.
Ages and Stages Questionnaire (ASQ)
Time Frame: 24 months corrected age
Ages and Stages Questionnaire (ASQ) is a parental questionnaire for assessment of general neurodevelopment
24 months corrected age
Swedish Parenthood Stress Questionnarie (SPSQ)
Time Frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.
Swedish Parenthood Stress Questionnarie (SPSQ) is a questionnaire that measures stress.
At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.
Resilience Scale (RES)
Time Frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.
Resilience Scale (RES) is a questionnaire that measures resilience.
At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.
Parental Self-Efficacy Scale (PSE)
Time Frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.
Parental Self-Efficacy Scale (PSE) is a questionnaire that measures parental self efficacy.
At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.
The Hospital Anxiety and Depression scale (HAD)
Time Frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age and 5,5 years of age.
The Hospital Anxiety and Depression scale (HAD) is a questionnaire that measures anxiety and depression. It will be used to assess parental mental health.
At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age and 5,5 years of age.
The State-Trait Anxiety Inventory (STAI)
Time Frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age and 5,5 years of age.
The State-Trait Anxiety Inventory (STAI) is a questionnaire that measures anxiety. It will be used to assess parental mental health.
At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age and 5,5 years of age.

Collaborators and Investigators

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

Sponsor

Umeå University

Investigators

  • Study Director: Magnus Domellöf, Professor, Umeå universitet

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 (Actual)

November 20, 2024

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 14, 2024

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPM Dnr 2024-03048-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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