Dyadic Interactions in Depressed and Non-Depressed Mothers and Their Infants

NCT ID: NCT00044174

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

701 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-08-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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:

* Psychiatric Interview: Subjects will participate in a 30-90 minute interview consisting of a series of standardized questions about the their behaviors and feelings. Participants whose interviews suggest a condition that may impact their mental health will be referred to the study clinician for follow-up to confirm or clarify the preliminary findings. Continued participation in the study will be determined following this.
* Home Visit: A study investigator will visit the home for 1 hour to film the mother and baby during the mother s typical daily activities. This visit will take place when the baby is about 5 months old. At the end of the visit, the mother will be given a variety of surveys to fill out at home and return at the next visit (see Lab Visit below). The survey questions deal with the mother s relationship with her partner, support from people in her life, typical behaviors of her infant, and how often she feels certain emotions. A packet of surveys will also be left for the participant s partner to complete and mail back to the investigator. The partner may or may not be the child s biological father and may or may not choose to participate in the study.
* Lab Visit: Within 1 week of the home visit, the mother and child will come to the NICHD clinic for about 2 hours. During this time, the mother will return the previous surveys and fill out another one regarding her current mood. She will then interact with her child, who will be seated in front of her. The 20-minute session will be videotaped. (There will be breaks during the session.) The mother will be instructed about how she should act (happy or sad). She and her baby will then participate in a variety of filmed situations that will induce certain emotions in the baby, such as happiness, fear, activity, frustration, and interest, in order to learn how different children react to different situations.

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..

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Infant maternal health Natural History

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Depressed Mothers/Infants

Mothers and their 5 month old infants who have been clinically diagnosed as exhibiting depressive symptoms

No interventions assigned to this group

Non-depressed Mothers/Infants

Mothers and their 5 month old infants who have been clinically diagnosed as not exhibiting depressive symptoms

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Exclusion Criteria

None
Minimum Eligible Age

5 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Diane L Putnick, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

02-CH-0278

Identifier Type: -

Identifier Source: secondary_id

020278

Identifier Type: -

Identifier Source: org_study_id