Evaluation of a Parent-Infant Interaction Model (LiMoNid)
Primary Purpose
Premature Birth
Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
LiMoNid
Sponsored by
About this trial
This is an interventional supportive care trial for Premature Birth focused on measuring Cognition, Family nursing, Infant, premature, Object attachment, Stress, physiological, Stress, psychological
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
Sites / Locations
- Linkoping University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard care
Observation
Arm Description
The family receive standard care when enrolled in the Neonatal intensive care unit
The family receive standard care when enrolled in the Neonatal intensive care unit and are also included in an observational program called LiMoNid.
Outcomes
Primary Outcome Measures
Cognitive abilities
Bayley Scales of Infant Development
Secondary Outcome Measures
Stress reactivity
Salivary cortisol reactivity in relation to bath
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02034617
Brief Title
Evaluation of a Parent-Infant Interaction Model
Acronym
LiMoNid
Official Title
Evaluation of a Parent-Infant Interaction Model in the Neonatal Intensive Care
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2014 (Actual)
Primary Completion Date
August 2021 (Actual)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
Cognition, Family nursing, Infant, premature, Object attachment, Stress, physiological, Stress, psychological
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
The family receive standard care when enrolled in the Neonatal intensive care unit
Arm Title
Observation
Arm Type
Experimental
Arm Description
The family receive standard care when enrolled in the Neonatal intensive care unit and are also included in an observational program called LiMoNid.
Intervention Type
Behavioral
Intervention Name(s)
LiMoNid
Intervention Description
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 Measure Information:
Title
Cognitive abilities
Description
Bayley Scales of Infant Development
Time Frame
11 months
Secondary Outcome Measure Information:
Title
Stress reactivity
Description
Salivary cortisol reactivity in relation to bath
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Cognitive abilities
Description
Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III)
Time Frame
4 years
Title
Stress reactivity
Description
Salivary cortisol reactivity in relation to still-face
Time Frame
4 months
Title
Stress reactivity
Description
Salivary cortisol reactivity in relation to a standardized play-situation, Infant Parent Social Interaction (IPSIC)
Time Frame
11 months
Title
Parent-child interaction
Description
Ainsworth sensitivity scale
Time Frame
1 month
Title
Parent-child interaction
Description
Still-face and Ainsworth sensitivity scale
Time Frame
4 months
Title
Parent-child interaction
Description
Infant Parent Social Interaction (IPSIC) and Attachment Story Stems
Time Frame
11 months
Title
Parental stress
Description
Edinburgh Post Depression Scale (EPDS) and State-Trait and Anxiety Inventory, short version (STAI)
Time Frame
1 month
Title
Parental stress
Description
Edinburgh Post Depression Scale (EPDS), State-Trait and Anxiety Inventory, short version (STAI) and Swedish Parenthood Stress Questionnaire (SPSQ)
Time Frame
4 months
Title
Parental stress
Description
State-Trait and Anxiety Inventory, short version (STAI) and Swedish Parenthood Stress Questionnaire (SPSQ)
Time Frame
11 months
Title
Parental stress
Description
State-Trait and Anxiety Inventory, short version (STAI)
Time Frame
4 years
Title
Parental style
Description
Parenting Scale (PS)
Time Frame
4 years
Title
Emotions
Description
Ages and Stages Questionnaire: Social and emotional (ASQ-SE)
Time Frame
4 months
Title
Emotions
Description
Ages and Stages Questionnaire: Social and emotional (ASQ-SE)
Time Frame
11 months
Title
Emotions
Description
Ages and Stages Questionnaire: Social and emotional (ASQ-SE) and Emotion Regulation Questionnaire for Children
Time Frame
4 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
96 Hours
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evalotte Morelius, PhD
Organizational Affiliation
Linkoping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linkoping University Hospital
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34205660
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.
Results Reference
derived
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Evaluation of a Parent-Infant Interaction Model
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