Evaluation of a Parent-Infant Interaction Model

Not Applicable

Completed

• Conditions: Premature Birth
• Interventions: Behavioral: LiMoNid

• Registration Number: NCT02034617
• Lead Sponsor: Linkoeping University

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.

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 Timeline

• Study First Submitted: 2013-12-19
• Study Start: 2014-01-01
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-13
• Primary Completion: 2021-08-31
• Study Completion: 2024-05-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cognitive abilities	11 months	Bayley Scales of Infant Development

Secondary Outcome Measures

Name	Time	Method
Stress reactivity	1 month	Salivary cortisol reactivity in relation to bath

Trial Locations

Locations (1)

Linkoping University Hospital; 🇸🇪 Linkoping, Sweden