Evaluation of a Parent-Infant Interaction Model

Premature Birth Clinical Trial

— LiMoNid  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034617
• Other study ID #: LinkoepingU
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2024
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 31, 2024
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 96 Hours

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

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

Locations

Country	Name	City	State
Sweden	Linkoping University Hospital	Linkoping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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 — View 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: 10.33 — View Citation

Outcome

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