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

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 290 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor New version filed on ClinicalTrials.gov
  2. Minor 49 versions Re-verified since Apr 18, 2024, no change to tracked fieldsv241-v289
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT00044174
Lead Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Depression
Enrollment 701 participants
Start Date
Updated on ClinicalTrials.gov