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Evaluation of a Parent-Infant Interaction Model (LiMoNid)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034617
Recruitment Status : Active, not recruiting
First Posted : January 13, 2014
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Evalotte Morelius, 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.


Condition or disease Intervention/treatment Phase
Premature Birth Behavioral: LiMoNid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of a Parent-Infant Interaction Model in the Neonatal Intensive Care
Actual Study Start Date : January 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
No Intervention: Standard care
The family receive standard care when enrolled in the Neonatal intensive care unit
Experimental: Observation
The family receive standard care when enrolled in the Neonatal intensive care unit and are also included in an observational program called LiMoNid.
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




Primary Outcome Measures :
  1. Cognitive abilities [ Time Frame: 11 months ]
    Bayley Scales of Infant Development


Secondary Outcome Measures :
  1. Stress reactivity [ Time Frame: 1 month ]
    Salivary cortisol reactivity in relation to bath


Other Outcome Measures:
  1. Cognitive abilities [ Time Frame: 4 years ]
    Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III)

  2. Stress reactivity [ Time Frame: 4 months ]
    Salivary cortisol reactivity in relation to still-face

  3. Stress reactivity [ Time Frame: 11 months ]
    Salivary cortisol reactivity in relation to a standardized play-situation, Infant Parent Social Interaction (IPSIC)

  4. Parent-child interaction [ Time Frame: 1 month ]
    Ainsworth sensitivity scale

  5. Parent-child interaction [ Time Frame: 4 months ]
    Still-face and Ainsworth sensitivity scale

  6. Parent-child interaction [ Time Frame: 11 months ]
    Infant Parent Social Interaction (IPSIC) and Attachment Story Stems

  7. Parental stress [ Time Frame: 1 month ]
    Edinburgh Post Depression Scale (EPDS) and State-Trait and Anxiety Inventory, short version (STAI)

  8. 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)

  9. Parental stress [ Time Frame: 11 months ]
    State-Trait and Anxiety Inventory, short version (STAI) and Swedish Parenthood Stress Questionnaire (SPSQ)

  10. Parental stress [ Time Frame: 4 years ]
    State-Trait and Anxiety Inventory, short version (STAI)

  11. Parental style [ Time Frame: 4 years ]
    Parenting Scale (PS)

  12. Emotions [ Time Frame: 4 months ]
    Ages and Stages Questionnaire: Social and emotional (ASQ-SE)

  13. Emotions [ Time Frame: 11 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 96 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034617


Locations
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Sweden
Linkoping University Hospital
Linkoping, Sweden, 581 85
Sponsors and Collaborators
Linkoeping University
Investigators
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Principal Investigator: Evalotte Morelius, PhD Linkoping University
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Responsible Party: Evalotte Morelius, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT02034617    
Other Study ID Numbers: LinkoepingU
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Evalotte Morelius, Linkoeping University:
Cognition
Family nursing
Infant, premature
Object attachment
Stress, physiological
Stress, psychological
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications