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Depression · Observational Study
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed observational study registration examining mother–infant dyadic interactions in depressed and non-depressed mothers, with primary outcome measures of child cognitive and socioemotional development and maternal psychosocial factors assessed at 5, 12, and 24 months. No results are reported in this registry record; the document describes study design and procedures only.
Observational. Depression; age from 5 Months. Intervention: Depressed Mothers/Infants; Non-depressed Mothers/Infants. Compared with: Comparison between depressed and non-depressed mothers on multiple outcome measures of child development and maternal psychosocial factors.. n = 701. 1 site: United States.
This is a completed observational study registration examining mother–infant dyadic interactions in depressed and non-depressed mothers, with primary outcome measures of child cognitive and socioemotional development and maternal psychosocial factors assessed at 5, 12, and 24 months. No results are reported in this registry record; the document describes study design and procedures only.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This study is not yet interpretable; results must be published separately to assess clinical relevance for understanding how maternal depression affects mother–infant interactions and infant development.
This is a completed observational registry record with no results posted; it describes study design and procedures only, making it a preliminary characterization of an ongoing research effort.
As stated by the source record.
Quoted from the source exactly as published.
This study is not yet interpretable; results must be published separately to assess clinical relevance for understanding how maternal depression affects mother–infant interactions and infant development.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT00044174). This is a study registration, not published results. Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 701 participants (ACTUAL). Conditions: Depression. Primary outcome measures: Multiple measures of child cognitive and socioemotional development as well as maternal psychosocial factors , When child is 5, 12, and 24 months. 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..
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