Linkoping University Hospital
Linköping, 581 85, Sweden
NCT Number: NCT02034617
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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All sexes
Interventional
Not applicable
Linköping, 581 85, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 11 months
Bayley Scales of Infant Development
Time frame: 1 month
Salivary cortisol reactivity in relation to bath
Time frame: 1 month
Ainsworth sensitivity scale
Time frame: 4 months
Salivary cortisol reactivity in relation to still-face
Time frame: 4 months
Still-face and Ainsworth sensitivity scale
Time frame: 1 month
Edinburgh Post Depression Scale (EPDS) and State-Trait and Anxiety Inventory, short version (STAI)
Time frame: 4 months
Edinburgh Post Depression Scale (EPDS), State-Trait and Anxiety Inventory, short version (STAI) and Swedish Parenthood Stress Questionnaire (SPSQ)
Time frame: 11 months
Infant Parent Social Interaction (IPSIC) and Attachment Story Stems
Time frame: 11 months
Salivary cortisol reactivity in relation to a standardized play-situation, Infant Parent Social Interaction (IPSIC)
Time frame: 11 months
State-Trait and Anxiety Inventory, short version (STAI) and Swedish Parenthood Stress Questionnaire (SPSQ)
Time frame: 11 months
Ages and Stages Questionnaire: Social and emotional (ASQ-SE)
Time frame: 4 years
Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III)
Time frame: 4 years
State-Trait and Anxiety Inventory, short version (STAI)
Time frame: 4 years
Parenting Scale (PS)
Time frame: 4 months
Ages and Stages Questionnaire: Social and emotional (ASQ-SE)
Time frame: 4 years
Ages and Stages Questionnaire: Social and emotional (ASQ-SE) and Emotion Regulation Questionnaire for Children
Linkoeping University
Other Gov
Evaluation of a Parent-Infant Interaction Model in the Neonatal Intensive Care
Acronym: LiMoNid
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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