Dyadic Interactions in Depressed and Non-Depressed Mothers and Their Infants
|First Received Date ICMJE||August 20, 2002|
|Last Updated Date||January 24, 2017|
|Start Date ICMJE||August 15, 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00044174 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Dyadic Interactions in Depressed and Non-Depressed Mothers and Their Infants|
|Official Title ICMJE||Dyadic Interactions in Depressed and Non-Depressed Mothers and Their Infants|
This study will examine 1) differences among mothers behaviors and how these behaviors influence their infants reactions, and 2) how mother-child interactions relate to children s temperament, and cognitive (thought processing) abilities, and other areas of development.
Depressed and non-depressed English-speaking mothers between 20 and 45 years of age, with an infant 4 months or younger, may be eligible for this study. Candidates will be screened with a mailed survey regarding their moods and feelings. Participants will undergo the following procedures:
Participants will be contacted to continue the study when their babies are 12 months old and again when the children are 24 months old. The above procedures will be repeated and some new measures will be added for toddlers that involve activities investigating aspects of early language and social reasoning..
Maternal depression is a concurrent and longitudinal risk factor for children s development. Maternal depression exerts direct effects and indirect effects through proximal processes of mother-child dyadic interactions. Both depressed mothers and their infants are inattentive, unresponsive, affectively flat, and disengaged during naturalistic interactions, and their dyadic interactions have been described as less synchronous. Our primary objective is to investigate differences between depressed and non-depressed dyads in maternal behaviors, child behaviors, and dyadic behaviors in terms of latency, synchrony, and contingency. In the present study, we propose to examine the determinants and effects of dyadic interactions of depressed and nondepressed mothers with their infants across several domains of child development. We plan to replicate and extend previous work by observing the dyads in naturalistic as well as experimental face-to-face settings at 5, 12, and 24 months.
Groups of depressed and nondepressed mothers will be selected on the basis of self-reports of depressive symptoms and by clinical diagnostic interviews. These assessments will be repeated at 12 and 24 months to assess the course of maternal depression. The study consists of a home visit, a lab visit, and administration of questionnaires to mothers and their spouses or partners at three time points. All maternal and child behaviors during dyadic interactions will be coded as continuous streams of data for analysis of reciprocal influences within the dyad. By coding a range of behaviors such as facial affect, vocalization, physical activity, and visual attention of the mother and infant, we hope to capture variations in mother-child interactions, both between and within depressed and nondepressed dyads. Differences in styles of dyadic interactions have been shown to have important consequences on subsequent child development in several domains. In addition, experimental simulations will consist of instructed 'depressed' and 'happy' simulations of mothers with their infants. Specific simulations allow observation of changes in infant behaviors from the spontaneous episodes and comparison between depressed and nondepressed dyads.
Understanding the context of child development, both normative and atypical, is important as means of elucidating the processes by which maternal depression operates as a risk factor for children s cognitive and socioemotional development. Several socio-demographic and psychosocial factors will be assessed by maternal and paternal self-reports to examine which factors exacerbate or buffer the effects of maternal depression. In addition to modifying the observations of maternal and child behaviors to be age-appropriate, new measures will be introduced at 12 and 24 months to capture child s functioning in multiple areas.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||850|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Mothers and infants must meet certain criteria to be included in the study. Selection criteria are: maternal age between 20 and 45 years, ability to read and write in English, normal pregnancy/delivery status without birth complications, term birth (+/- 14 days from due date), and singleton status of the child. Approximately equal numbers of male and female infants will be recruited, and to the extent possible, the two groups of depressed and nondepressed mothers will be matched on ethnic composition. Participants will be seen at 5, 12, and 24 months.
|Ages||up to 45 Years (Child, Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00044174|
|Other Study ID Numbers ICMJE||020278, 02-CH-0278|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Study Sponsor ICMJE||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||October 17, 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP