Clinical trial NCT02034617: Evaluation of a Parent-Infant Interaction Model
Official title: Evaluation of a Parent-Infant Interaction Model in the Neonatal Intensive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: Cognition
Family nursing
Infant, premature
Object attachment
Stress, physiological
Stress, psychological
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2014-01-13
Enrollment: 140
Sex: ALL
Maximum age (years): 96
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive abilities
timeFrame: 11 months
Secondary outcomes:
measure: Stress reactivity
timeFrame: 1 month
Other outcomes:
measure: Parent-child interaction
timeFrame: 1 month
measure: Stress reactivity
timeFrame: 4 months
measure: Parent-child interaction
timeFrame: 4 months
measure: Parental stress
timeFrame: 1 month
measure: Parental stress
timeFrame: 4 months
measure: Parent-child interaction
timeFrame: 11 months
measure: Stress reactivity
timeFrame: 11 months
measure: Parental stress
timeFrame: 11 months
measure: Emotions
timeFrame: 11 months
measure: Cognitive abilities
timeFrame: 4 years
measure: Parental stress
timeFrame: 4 years
measure: Parental style
timeFrame: 4 years
measure: Emotions
timeFrame: 4 months
measure: Emotions
timeFrame: 4 years
Locations:
city: Linkoping
country: Sweden
facility: Linkoping University Hospital
Study officials:
affiliation: Linkoeping University
name: Evalotte Morelius, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.