NCT00044174

Brief Summary

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..

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
701

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2002

Completed
Same day until next milestone

Study Start

First participant enrolled

August 20, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2002

Completed
Last Updated

May 7, 2026

Status Verified

December 19, 2025

First QC Date

August 20, 2002

Last Update Submit

May 6, 2026

Conditions

Keywords

Infantmaternal healthNatural History

Outcome Measures

Primary Outcomes (1)

  • Multiple measures of child cognitive and socioemotional development as well as maternal psychosocial factors

    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.

    When child is 5, 12, and 24 months

Study Arms (2)

Depressed Mothers/Infants

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

Non-depressed Mothers/Infants

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

Eligibility Criteria

Age5 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Diane L Putnick, Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2002

First Posted

August 21, 2002

Study Start

August 20, 2002

Last Updated

May 7, 2026

Record last verified: 2025-12-19

Data Sharing

IPD Sharing
Will not share

Locations