Evaluation of a Parent-Infant Interaction Model

NCT02034617 | Completed

• 1 other identifier: LinkoepingU
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

When becoming a parent of a preterm infant there is an increased risk of stress. There are a number of studies showing that parental stress has a negative impact on their engagement with their child. Other studies, on the other hand, show that different intervention programs with the aim to strengthen the relationship can decrease parental stress and hence affect the parent-infant interaction in a positive way. Structured intervention programs for preterm infants have also been successful in improving the infants' cognitive functions. The investigators have developed a program with the aim to strengthen the parent-infant interaction for late preterm infants. The observational program is called LiMoNid. Our hypothesis is that LiMoNid will strengthen the parents' own parental abilities and give them a deeper understanding of their child. They will hopefully develop more skills on how to communicate with their child; to see, interpret, understand and approach the child, which can lead to an improved parent-child interaction. Parental stress may also be reduced by increased understanding and control. Regarding the child itself, we hypothesize that the psychological development will be affected depending on the communication with the caregiver and depending on the support it has received in expressing its feelings and needs. The emotional regulation should be strengthened by such an intervention. The aim is to study if LiMoNid can have an impact on cognition, stress, parent-child interaction.

Conditions

Premature Birth

Keywords

Cognition; Family nursing; Infant, premature; Object attachment; Stress, physiological; Stress, psychological

Outcome Measures

Primary Outcomes (1)

• Cognitive abilities

  Bayley Scales of Infant Development

  11 months

Secondary Outcomes (1)

• Stress reactivity

  1 month

Other Outcomes (14)

• Parent-child interaction

  1 month

• Stress reactivity

  4 months

• Parent-child interaction

  4 months

Study Arms (2)

Standard care

NO INTERVENTION

The family receive standard care when enrolled in the Neonatal intensive care unit

Observation

EXPERIMENTAL

The family receive standard care when enrolled in the Neonatal intensive care unit and are also included in an observational program called LiMoNid.

Behavioral: LiMoNid

Interventions

LiMoNid BEHAVIORAL

One LiMoNid observation will be performed on day 1-3 post birth, one in time of discharge, and one in the home when the infant has reached 40 weeks (+/- 2 week). All observations are performed in presence of and in collaboration with the parents with the outspoken aim to guide the parents to learn how to read and respond to their infant' signals

Observation

Eligibility Criteria

• Age: Up to 96 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants born 30-36 weeks gestational age without known major malformations or complications
• Families living in the county of Ostergotland, Sweden
• Swedish speaking parents
• Single or duplex birth

You may not qualify if:

• Complications encountered during hospital stay that are known to affect cognition

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linkoping University Hospital

Linköping, 581 85, Sweden

Location

Related Publications (3)

• Helmer CS, Thornberg UB, Abrahamsson T, Morelius E. Mothers' experiences of a new early collaborative intervention, the EACI, in the neonatal period: A qualitative study. J Clin Nurs. 2023 Jun;32(11-12):2892-2902. doi: 10.1111/jocn.16412. Epub 2022 Jun 14.

  PMID: 35702001 RESULT

• Helmer CS, Thornberg UB, Morelius E. An Early Collaborative Intervention Focusing on Parent-Infant Interaction in the Neonatal Period. A Descriptive Study of the Developmental Framework. Int J Environ Res Public Health. 2021 Jun 21;18(12):6656. doi: 10.3390/ijerph18126656.

  PMID: 34205660 RESULT

• Birberg Thornberg U, Koch FS, Helmer CS, Tell J, Nyberg E, Abrahamsson T, Morelius E. Moderate-To-Late Preterm Infants Benefit From the Early Collaborative Intervention: Primary Outcomes of an RCT. Acta Paediatr. 2025 Nov;114(11):2838-2846. doi: 10.1111/apa.70173. Epub 2025 Jun 13.

  PMID: 40511708 DERIVED

MeSH Terms

Conditions

Premature Birth; Stress, Psychological

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavioral Symptoms; Behavior

Study Officials

• Evalotte Morelius, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: January 13, 2014
• Study Start: January 1, 2014
• Primary Completion: August 31, 2021
• Study Completion: May 31, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)