Mother-Infant Interaction Clinical Trial
Official title:
Assessing the Effect of the Newborn Behavioral Observations System on Maternal Sensitivity Four Months Post-partum
Verified date | February 2021 |
Source | Center for Parents and Infants, Iceland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study evaluates if the Newborn Behavioral Observation system, a relationship building tool, delivered to at risk mothers will have, on one site, an effect on maternal sensitivity and the other site on Childs responsiveness, measured by the Emotional Availability (EA) Scales at 4 months post partum.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 17, 2019 |
Est. primary completion date | July 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Pregnant women and their partners - Age of 18 or more. - Understanding Icelandic. - Having score of EPDS scale of more than 9 or history of depression and/or anxiety Exclusion Criteria: - Not speaking or understanding Icelandic. - Having given birth within 35 weeks of pregnancy. - Having a sick baby |
Country | Name | City | State |
---|---|---|---|
Iceland | Stefanía Birna Arnardóttir | Reykjavík | Ísland |
Lead Sponsor | Collaborator |
---|---|
Center for Parents and Infants, Iceland | Health care of the capital area, Iceland, Regionsenter for barn og unges psykiske helse, Norway, Research and Analysis, v/University of Reykjavik, The Icelandic Nurses' Association |
Iceland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maternal sensitivity | Maternal sensitivity is measured in the dyad of mother-infant communication; as appropriate responsiveness and ability to handle conflicts in the relationship. Scores for each subscale range from 1-7, higher scores indicating more sensitivity. Direct score range from 7-29, higher scores indicate more sensitivity. Direct score leads to Clinical-Screener score which is reated on a 100 point dimentional scale, divided into four zones; Emotional-Availability (81-100), Complicated E-A (61-80), Unavailable/Detached E-A (41-60) and Problematic/disturbed E-A (1-40).
The EA Scale is validated in various settings and cultures and will serve as the main outcome measure in the RCT. |
Maternal sensitivity will be measured 3 months after the third NBO session at infant ages 4 months | |
Primary | Childs responsiveness | Childs responsiveness is measured in the dyad of mother-infant communication; as willingness to respond to bids of the adult without over-compliance. Scores for each subscale range from 1-7, higher scores indicating more responsivenss. Direct score range from 7-29, higher scores indicate more responsiveness. Direct score leads to Clinical-Screener score which is rated on a 100 point dimentional scale, divided into four zones; Emotional-Availability (81-100), Complicated E-A (61-80), Unavailable/Detached E-A (41-60) and Problematic/disturbed E-A (1-40) | Childs responsiveness will be measured 3 months after the third NBO session at infant ages 4 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04665440 -
Response of Preterm Infants to Multisensory Stimuli
|
N/A | |
Not yet recruiting |
NCT06096961 -
The Effect Of Baby Smell On The Amount Of Breast Milk, Salivary Cortisol Level And Mother Baby Attachment
|
N/A | |
Recruiting |
NCT04899765 -
Measles and BCG Vaccines for Mother and Child
|
Phase 4 | |
Completed |
NCT04883944 -
Maternal Involvement in Pain Management in NICU
|
N/A | |
Completed |
NCT05830955 -
The Effect of Lullaby and Breastmilk Smell on Preterm Newborns
|
N/A | |
Completed |
NCT03664154 -
Stress and Feeding (SAFE): A Pilot Intervention for Mothers and Their Preterm Infants
|
N/A | |
Not yet recruiting |
NCT06390540 -
Mobile-Based Exercise in Postpartum Period
|
N/A | |
Recruiting |
NCT05812833 -
Web-Based Baby Care Education Meleis' Transition Theory Mother's Self-Confidence Newborn Health
|
N/A | |
Completed |
NCT06198478 -
Tandem: Skin-to-skin Transfer From the Delivery Room to the Neonatal Unit
|
||
Recruiting |
NCT06030830 -
SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers
|
N/A | |
Enrolling by invitation |
NCT05700162 -
The Effect of Showing Photographs, Videos and Live Images of Their Babies to Mothers During Milking
|
N/A | |
Active, not recruiting |
NCT03814395 -
Peking University Birth Cohort in Tongzhou
|
||
Not yet recruiting |
NCT05861531 -
Learning to Talk, Learning to Eat: A Randomized Controlled Trial to Improve NICU Oral Feeding and Language Outcomes
|
N/A | |
Completed |
NCT04396509 -
Effects of Type of Delivery Mode and Gestational Age on Maternal Bonding
|
||
Completed |
NCT04908332 -
Effect of Kangaroo Baby Massage on Mother-infant Interaction at Home
|
N/A | |
Recruiting |
NCT06237088 -
Mother-infant Connection Strategy Program
|
N/A | |
Terminated |
NCT04233489 -
Clinical Interventions to Mitigate Neurodevelopmental Risk
|
N/A | |
Recruiting |
NCT05781100 -
Investigating Baby Behavior and Family Technology Use Study
|
N/A | |
Completed |
NCT06269458 -
The Effects of Mother-Baby Yoga and Baby Massage on Attachment and Sleep
|
N/A | |
Completed |
NCT06359288 -
Preterm Newborn Mothers' Anxiety and Self-Efficacy
|
N/A |