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Completed

NCT Number: NCT02034617

Evaluation of a Parent-Infant Interaction Model

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.

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Key information

Age range

Up to 96 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linkoping University Hospital

Linköping, 581 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Cognitive abilities

    Time frame: 11 months

    Bayley Scales of Infant Development

Secondary outcomes

  1. Stress reactivity

    Time frame: 1 month

    Salivary cortisol reactivity in relation to bath

Other outcomes

  1. Parent-child interaction

    Time frame: 1 month

    Ainsworth sensitivity scale

  2. Stress reactivity

    Time frame: 4 months

    Salivary cortisol reactivity in relation to still-face

  3. Parent-child interaction

    Time frame: 4 months

    Still-face and Ainsworth sensitivity scale

  4. Parental stress

    Time frame: 1 month

    Edinburgh Post Depression Scale (EPDS) and State-Trait and Anxiety Inventory, short version (STAI)

  5. Parental stress

    Time frame: 4 months

    Edinburgh Post Depression Scale (EPDS), State-Trait and Anxiety Inventory, short version (STAI) and Swedish Parenthood Stress Questionnaire (SPSQ)

  6. Parent-child interaction

    Time frame: 11 months

    Infant Parent Social Interaction (IPSIC) and Attachment Story Stems

  7. Stress reactivity

    Time frame: 11 months

    Salivary cortisol reactivity in relation to a standardized play-situation, Infant Parent Social Interaction (IPSIC)

  8. Parental stress

    Time frame: 11 months

    State-Trait and Anxiety Inventory, short version (STAI) and Swedish Parenthood Stress Questionnaire (SPSQ)

  9. Emotions

    Time frame: 11 months

    Ages and Stages Questionnaire: Social and emotional (ASQ-SE)

  10. Cognitive abilities

    Time frame: 4 years

    Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III)

  11. Parental stress

    Time frame: 4 years

    State-Trait and Anxiety Inventory, short version (STAI)

  12. Parental style

    Time frame: 4 years

    Parenting Scale (PS)

  13. Emotions

    Time frame: 4 months

    Ages and Stages Questionnaire: Social and emotional (ASQ-SE)

  14. Emotions

    Time frame: 4 years

    Ages and Stages Questionnaire: Social and emotional (ASQ-SE) and Emotion Regulation Questionnaire for Children

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

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

Acronym: LiMoNid

Important dates

Study start
2014
Primary completion
2021
Study completion
2024
First posted
Jan 13, 2014
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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