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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

02-CH-0278

Sponsoring Institute

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 5 mo
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

None

Keywords

Infant;
maternal health;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Depression

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Child Health and Human Development

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..

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Eligibility

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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Diane L. Putnick, Ph.D.
National Institute of Child Health and Human Development (NICHD)
National Institutes of Health
6555 Rock Spring Dr, Suite 220
Bethesda, Maryland 20817
(301) 496-6291
putnickd@mail.nih.gov

Diane L. Putnick, Ph.D.
National Institute of Child Health and Human Development (NICHD)
National Institutes of Health
6555 Rock Spring Dr, Suite 220
Bethesda, Maryland 20817
(301) 496-6291
putnickd@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00044174

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