Child DevelopmentNCT00361829
The Influence of Maternal Age, Employment Status, and Parenthood Status on Children's Cognitive Development
An observational study of Child Development, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 4 sites in 4 countries.
Trial summary
Research and theory tend to agree when suggesting that certain activities done by mothers have both immediate and delayed consequences for children's mental development in the first years of life. The everyday interaction between an infant and a caregiver can be broken down into many categories. Read more about this study
- Who is it for?
- Ages 5 months to 23 years
- Conditions the study is for
- Child Development
- How many people
- 2,355 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 17 Feb 1988to 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 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Mother-infant interaction will be observed when the infants are 5 months old. When the children are 20 months old, measures of toddler function (e.g., ability to play and language development) and maternal behavior (e.g., encouragement of attention to the environment and I.Q.) will be obtained. When the children are 48 months old, researchers will measure preschooler psychosocial functioning (e.g., I.Q., cognitive and social competencies) and maternal behavior (e.g., "scaffolding").
Who may be able to join
- All subjects are normal volunteers.
- At initial recruitment, all mothers will be married women living in intact families with healthy, full-term, first-born infants. Most will be living in intact families.
- Prior to inclusion in the sample, basic demographic information will be obtained for all study participants including substitute caregivers but excluding school teachers. Variables include age, race, cultural background, primary language, marital status, SES (as assessed by the Hollingshead Four-Factor Index of Social Status, 1975), and educational level. In addition, for caregivers, information about their experience caring for children and about the peer environment, including the number of children routinely present, their sexes, and their ages, will be obtained.
- To the extent that the adolescent sample diverges from sample criteria with respect to marital status and SES, appropriate controls will be used.
- Subjects in the Argentine-American and Japanese-American project will be selected to represent families high vs low on appropriate measures of acculturation.
- The healthy second born infants of 80 mothers already enrolled in the protocol will also be recruited into the sample at the time of their birth. These infants will be selected to comprise four equal groups based on the gender composition of the sibling dyad: male/male, male/female, female/female, and female/male.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Brazil1 site
Federal University of Rio de Janeiro-Participants Homes
Rio de Janeiro
About this study
Official title: Specificity of Mother-Infant Interaction: The Influence of Maternal Age, Employment Status, and Parenthood Status
Research and theory tend to agree when suggesting that certain activities done by mothers have both immediate and delayed consequences for children's mental development in the first years of life.
The everyday interaction between an infant and a caregiver can be broken down into many categories. There are data linking both of these types of interaction to the mental development of children.
Read more
The study will focus on the extent to which maternal characteristics (age, employment status, parenthood status, and birth order of the child) influence the relation between maternal social and didactic caregiving and the social and mental development of children.
Mother-infant interaction will be observed when the infants are 5 months old.
When the children are 20 months old, measures of toddler function (e.g., ability to play and language development) and maternal behavior (e.g., encouragement of attention to the environment and I.Q.) will be obtained.
When the children are 48 months old, researchers will measure preschooler psychosocial functioning (e.g., I.Q., cognitive and social competencies) and maternal behavior (e.g., "scaffolding").
Understanding the relation between children's experiences as infants, toddlers, and preschoolers and their eventual intellectual and social functioning is an essential part of normal developmental research.<TAB>
Read the detailed description
Research and theory concur in suggesting that certain maternal activities have both immediate and protracted consequences for children's cognitive development in the first years of life. Two conceptually distinct categories of caretaker-child interactions can be identified: social and didactic. These encompass much of the everyday behavior of infants' caretakers. There are data linking both of these types of behavior to cognitive development in children. In previous work we have investigated these relations in early infancy using samples of convenience. In the proposed study set, this work will be replicated and extended by focusing on the extent to which the characteristics of maternal age, employment status, parenthood status and birthorder of the child influence observed relations between maternal, social and didactic caretaking on the one hand and infant, toddler, preschool age, and middle childhood, and adolescent social and cognitive competencies on the other. For a subset of infants of employed mothers, their substitute caregivers will be added to the sample. Understanding the full range of experience for those infants with multiple caregivers is important in the context of a study designed to elucidate dimensions of experience that influence social and cognitive development. Naturalistic mother-infant interaction will be observed when infants are 5 months old. When study participants are 20 months old, measures of toddler functioning (e.g., play competence and language development) and maternal behavior (e.g., encouragement of attention to the environment, I.Q.) will be obtained. At 48 months, measures of preschooler psychosocial functioning (e.g., I.Q., cognitive and social competencies) and maternal behavior (e.g., "scaffolding") will be obtained. At age 10 and 14 years, data assessing the child's adjustment, development, and functioning in multiple areas will be obtained from the child, both parents, and the schoolteacher (age 10 only). Measures of parental attitudes and family functioning will also be obtained. Theoretical formulations about how specific parent-child interactions may contribute to cognition have challenged investigators to look beyond demographic variables as markers of parental stimulation and to consider specific relations between types of interactions and the acquisition of particular skills at different points in time. Understanding the mechanisms linking experience in early infancy through toddlerhood, the preschool years, middle childhood and early adolescence with intellectual and social functioning is an essential aspect of normative developmental research. In addition, examining these phenomena cross-culturally will contribute importantly to our understanding of children and their families.
- Conditions
- Child Development
- Keywords
- Childhood Growth and Development, Natural History
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 |
|---|---|---|
| Ecologic/Community | Married women, infants, caregivers, Japanese-American, Argentine-American |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of child adaptive functioning
Measures of child adaptive functioning
Measured: 5, 20,and 48 months, 10 years, 14 years, 18 years, and 23 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2006 (estimated)
- Study start17 Feb 1988
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 2,355 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
- NCT00361829
- Sponsor's protocol ID
- 880032
- Other IDs
- 88-CH-0032
- Status last verified
- 22 Sep 2026
- First submitted
- 8 Aug 2006
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The protocol does not make mention of IPD sharing.
Publications
Rowe A. Characteristics of hospital care. Nurs Times. 1969 Oct 23;65(43):1376-7. No abstract available.
PubMed 5823787Kuiumdzhieva A, Denchev D. [ATP yield from yeasts of the genera Candida and Torulopsis cultured in a chemostat on a methanol medium]. Acta Microbiol Bulg. 1984;15:50-5. No abstract available. Bulgarian.
PubMed 6541423Smith WL, Egle JL Jr, Adams MD. Adrenergic receptors in the nucleus tractus solitarii of the rat. Eur J Pharmacol. 1982 Jun 16;81(1):11-9. doi: 10.1016/0014-2999(82)90596-9.
PubMed 6126366
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specificity of Mother-Infant Interaction: The Influence of Maternal Age, Employment Status, and Parenthood Status
- ClinicalTrials.gov ID
- NCT00361829
- Acronym / sponsor ID
- 880032
- Conditions
- Child Development
- Keywords
- Childhood Growth and Development, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,355 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 17 Feb 1988 (actual)
- First posted
- 9 Aug 2006 (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.
Research and theory tend to agree when suggesting that certain activities done by mothers have both immediate and delayed consequences for children's mental development in the first years of life.
The everyday interaction between an infant and a caregiver can be broken down into many categories. There are data linking both of these types of interaction to the mental development of children.
The study will focus on the extent to which maternal characteristics (age, employment status, parenthood status, and birth order of the child) influence the relation between maternal social and didactic caregiving and the social and mental development of children.
Mother-infant interaction will be observed when the infants are 5 months old.
When the children are 20 months old, measures of toddler function (e.g., ability to play and language development) and maternal behavior (e.g., encouragement of attention to the environment and I.Q.) will be obtained.
When the children are 48 months old, researchers will measure preschooler psychosocial functioning (e.g., I.Q., cognitive and social competencies) and maternal behavior (e.g., "scaffolding").
Understanding the relation between children's experiences as infants, toddlers, and preschoolers and their eventual intellectual and social functioning is an essential part of normal developmental research.<TAB>
Detailed description
Research and theory concur in suggesting that certain maternal activities have both immediate and protracted consequences for children's cognitive development in the first years of life. Two conceptually distinct categories of caretaker-child interactions can be identified: social and didactic. These encompass much of the everyday behavior of infants' caretakers. There are data linking both of these types of behavior to cognitive development in children. In previous work we have investigated these relations in early infancy using samples of convenience. In the proposed study set, this work will be replicated and extended by focusing on the extent to which the characteristics of maternal age, employment status, parenthood status and birthorder of the child influence observed relations between maternal, social and didactic caretaking on the one hand and infant, toddler, preschool age, and middle childhood, and adolescent social and cognitive competencies on the other. For a subset of infants of employed mothers, their substitute caregivers will be added to the sample. Understanding the full range of experience for those infants with multiple caregivers is important in the context of a study designed to elucidate dimensions of experience that influence social and cognitive development. Naturalistic mother-infant interaction will be observed when infants are 5 months old. When study participants are 20 months old, measures of toddler functioning (e.g., play competence and language development) and maternal behavior (e.g., encouragement of attention to the environment, I.Q.) will be obtained. At 48 months, measures of preschooler psychosocial functioning (e.g., I.Q., cognitive and social competencies) and maternal behavior (e.g., "scaffolding") will be obtained. At age 10 and 14 years, data assessing the child's adjustment, development, and functioning in multiple areas will be obtained from the child, both parents, and the schoolteacher (age 10 only). Measures of parental attitudes and family functioning will also be obtained. Theoretical formulations about how specific parent-child interactions may contribute to cognition have challenged investigators to look beyond demographic variables as markers of parental stimulation and to consider specific relations between types of interactions and the acquisition of particular skills at different points in time. Understanding the mechanisms linking experience in early infancy through toddlerhood, the preschool years, middle childhood and early adolescence with intellectual and social functioning is an essential aspect of normative developmental research. In addition, examining these phenomena cross-culturally will contribute importantly to our understanding of children and their families.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ecologic/Community | – | –Married women, infants, caregivers, Japanese-American, Argentine-American |
Who may qualify
- Ages
- 5 months to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Mother-infant interaction will be observed when the infants are 5 months old. When the children are 20 months old, measures of toddler function (e.g., ability to play and language development) and maternal behavior (e.g., encouragement of attention to the environment and I.Q.) will be obtained. When the children are 48 months old, researchers will measure preschooler psychosocial functioning (e.g., I.Q., cognitive and social competencies) and maternal behavior (e.g., "scaffolding").
Key inclusion criteria (6 listed)
- All subjects are normal volunteers.
- At initial recruitment, all mothers will be married women living in intact families with healthy, full-term, first-born infants. Most will be living in intact families.
- Prior to inclusion in the sample, basic demographic information will be obtained for all study participants including substitute caregivers but excluding school teachers. Variables include age, race, cultural background, primary language, marital status, SES (as assessed by the Hollingshead Four-Factor Index of Social Status, 1975), and educational level. In addition, for caregivers, information about their experience caring for children and about the peer environment, including the number of children routinely present, their sexes, and their ages, will be obtained.
- To the extent that the adolescent sample diverges from sample criteria with respect to marital status and SES, appropriate controls will be used.
- Subjects in the Argentine-American and Japanese-American project will be selected to represent families high vs low on appropriate measures of acculturation.
Key exclusion criteria (0 listed)
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
Measures of child adaptive functioning
Time frame: 5, 20,and 48 months, 10 years, 14 years, 18 years, and 23 years
Measures of child adaptive functioning
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 2 Oct 2026.
- Background: PubMed 5823787Rowe A. Characteristics of hospital care. Nurs Times. 1969 Oct 23;65(43):1376-7. No abstract available.
- Background: PubMed 6541423Kuiumdzhieva A, Denchev D. [ATP yield from yeasts of the genera Candida and Torulopsis cultured in a chemostat on a methanol medium]. Acta Microbiol Bulg. 1984;15:50-5. No abstract available. Bulgarian.
- Background: PubMed 6126366Smith WL, Egle JL Jr, Adams MD. Adrenergic receptors in the nucleus tractus solitarii of the rat. Eur J Pharmacol. 1982 Jun 16;81(1):11-9. doi: 10.1016/0014-2999(82)90596-9.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. The protocol does not make mention of IPD sharing.
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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)
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 4 sites in 4 countries.
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 6 inclusion and 0 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Brazil, Cameroon, Canada. 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?
Measures of child adaptive functioning (time frame: 5, 20,and 48 months, 10 years, 14 years, 18 years, and 23 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00361829, which also lists 3 linked publications.
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 2 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.