Evaluation of a Parent-Infant Interaction Model (LiMoNid)

Evaluation of a Parent-Infant Interaction Model in the Neonatal Intensive Care

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Premature Birth
• Intervention / Treatment: Behavioral: LiMoNid

Detailed Description

The Design is a randomised controlled study in two groups; intervention group versus standard care. Parents who meet the inclusion criteria are given oral and written information about the study aim and procedure and are asked for participation. If the parents consent they will be randomised to one of two groups. Follow-ups will be conducted at 1 month, 4 months, 10-12 months corrected age and when the child is 4 years.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linkoping, Sweden, 581 85
    • Linkoping University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 days (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care; The family receive standard care when enrolled in the Neonatal intensive care unit
Experimental: Observation; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive abilities	Bayley Scales of Infant Development	11 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress reactivity	Salivary cortisol reactivity in relation to bath	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive abilities	Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III)	4 years
Stress reactivity	Salivary cortisol reactivity in relation to still-face	4 months
Stress reactivity	Salivary cortisol reactivity in relation to a standardized play-situation, Infant Parent Social Interaction (IPSIC)	11 months
Parent-child interaction	Ainsworth sensitivity scale	1 month
Parent-child interaction	Still-face and Ainsworth sensitivity scale	4 months
Parent-child interaction	Infant Parent Social Interaction (IPSIC) and Attachment Story Stems	11 months
Parental stress	Edinburgh Post Depression Scale (EPDS) and State-Trait and Anxiety Inventory, short version (STAI)	1 month
Parental stress	Edinburgh Post Depression Scale (EPDS), State-Trait and Anxiety Inventory, short version (STAI) and Swedish Parenthood Stress Questionnaire (SPSQ)	4 months
Parental stress	State-Trait and Anxiety Inventory, short version (STAI) and Swedish Parenthood Stress Questionnaire (SPSQ)	11 months
Parental stress	State-Trait and Anxiety Inventory, short version (STAI)	4 years
Parental style	Parenting Scale (PS)	4 years
Emotions	Ages and Stages Questionnaire: Social and emotional (ASQ-SE)	4 months
Emotions	Ages and Stages Questionnaire: Social and emotional (ASQ-SE)	11 months
Emotions	Ages and Stages Questionnaire: Social and emotional (ASQ-SE) and Emotion Regulation Questionnaire for Children	4 years

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Evalotte Morelius, PhD, Linköping University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): August 31, 2021
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (Estimated): January 13, 2014

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cognition; Family nursing; Infant, premature; Object attachment; Stress, physiological; Stress, psychological
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: LinkoepingU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO