DepressionNCT00044174
Dyadic Interactions in Depressed and Non-Depressed Mothers and Their Infants
An observational study of Depression, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 months and older
- Conditions the study is for
- Depression
- How many people
- 701 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2002to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Dyadic Interactions in Depressed and Non-Depressed Mothers With Their Infants
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:
Read more
- 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..
Read the detailed description
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
- Depression
- Keywords
- Infant, maternal health, Natural History
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: When child is 5, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2002 (estimated)
- Study start20 Aug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 701 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Diane L Putnick, Ph.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044174
- Sponsor's protocol ID
- 020278
- Other IDs
- 02-CH-0278
- Status last verified
- 22 Sep 2026
- First submitted
- 20 Aug 2002
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyadic Interactions in Depressed and Non-Depressed Mothers With Their Infants
- ClinicalTrials.gov ID
- NCT00044174
- Acronym / sponsor ID
- 020278
- Conditions
- Depression
- Keywords
- Infant, maternal health, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 701 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 20 Aug 2002 (actual)
- First posted
- 21 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 5 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Multiple measures of child cognitive and socioemotional development as well as maternal psychosocial factors
Time frame: When child is 5, 12, and 24 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane L Putnick, Ph.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple measures of child cognitive and socioemotional development as well as maternal psychosocial factors (time frame: When child is 5, 12, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.