Postpartum DepressionNCT02121496
Social Circumstances, Parenting Techniques, and Infant Development
A study testing Resources for Postpartum Parenting in people with Postpartum Depression and Infant Development, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
1. Investigators aim to assess a novel behavioral intervention (currently approved in Protocol #6285) behavioral intervention that promotes maternally-mediated behavioral changes in young infants to reduce the risk of postpartum depression in a group of low income women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Infant Development, Rhythm; Sleep
- What is being tested?
- Resources for Postpartum Parenting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2019
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnant women between 24 and 38 weeks gestation (based on self-report)
- Ages 18-45 (based on self-report) 3. English speaking (based on self-report)
- Salary indicated to be at New York City standardized "Struggling level" or lower - $47,700 annual for a family of 4 (based on self-report)
- Experiencing one or more of nine social adversity hardships (based on self report)
- Experiencing a healthy pregnancy, free from any significant medical complication (based on self-report)
- Receiving standard prenatal care (based on self-report)
Who cannot join
- Multi-fetal pregnancy (based on self-report)
- Smoking, illicit drug use, or alcohol use during pregnancy (based on self-report)
- Acute medical illness or significant pregnancy complication (based on self-report)
- Currently in weekly, individual psychotherapy - group therapy and psychiatric management ok (based on self-report)
- Psychotic d/o; Bipolar I; Major Depressive d/o (based on M.I.N.I.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
- Investigators aim to assess a novel behavioral intervention (currently approved in Protocol #6285) behavioral intervention that promotes maternally-mediated behavioral changes in young infants to reduce the risk of postpartum depression in a group of low income women. More specifically, investigators aim to determine if a behavioral intervention targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior and thereby: (1) reduce the incidence and/or severity of postpartum maternal depression in low socioeconomic status (SES) women, and (2) improve the quality of mother-infant interaction and subsequent child development. Investigators will study:
- The feasibility of applying this protocol with a low SES population
- The effectiveness of the intervention compared to usual care
- If the effects of the intervention can be detected in assessments of the quality of mother-infant interaction and infant neurocognitive development
- Investigators aim to determine whether this behavioral intervention can affect infant development as measured by neurodevelopmental assessments and cortisol reactivity at 4 months of age.
Read the detailed description
Developmental research consistently shows that postpartum depression has a negative impact on cognitive and emotional development during infancy and childhood. Low SES women face unique stressors and social challenges. Rates of postpartum depression are significantly higher in this group (23-33%) than in the general population (10-15%).
The purpose of this study is to understand how social circumstances, women's mood, and parenting techniques affect infant and child development. Specifically, investigators are interested in finding out whether a behavioral intervention, already being administered in IRB approved protocol #6285, targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, thereby reducing the incidence and/or severity of maternal depression and anxiety symptoms, improving the quality of the mother-infant interaction, and improving infant developmental outcomes.
By collecting stress reports from women from low SES backgrounds during pregnancy and the postpartum period and by conducting follow-up observational assessments of the quality of mother-infant interaction, infant learning, infant cortisol reactivity, and infant neurocognitive development, investigators hope to identify whether this intervention can effectively meet these aims.
- Conditions
- Postpartum Depression, Infant Development, Rhythm; Sleep
- Being tested
- Resources for Postpartum Parenting
- Keywords
- Depression, Development, Infant sleep
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resources for Postpartum ParentingBehavioural
Also called Practical Resources for Effective Postpartum Parenting
The intervention includes four-sessions that targets maternal caregiving of young infants to increase infant sleep and reduce fuss/cry behavior and thereby simultaneously consolidate women's enjoyment of and confidence in their maternal role, this, in turn, promotes a cycle of a mutually re- warding engagement in the mother-infant dyad - the antithesis of a 'toxic' experience, and a strong foundation for improving the chances of a successful psychosocial adjustment, including adequate employment. Investigators believe PREPP holds tremendous promise as an intervention to fill the science-practice gap in the promotion of an optimal emotional environment for the developing infant, particularly for women and children living in poverty and/or facing significant psychosocial hardship.
| Study group | Role | What they receive |
|---|---|---|
| Resources for Postpartum Parenting | Experimental | Behavioral intervention will include techniques to help mothers get their infants to cry/fuss less and sleep more to determine if this has an effect on prevalence of postpartum depression in low SES women and if it improves the quality of mother-infant interaction and subsequent child development. Receives: Behavioral: Resources for Postpartum Parenting |
| Control Group | No intervention | This group will not receive the coaching tips to help babies cry less and sleep more. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maternal mood and prevalence/severity of postpartum depression.
Investigators will be assessing and tracking the incidence and/or severity of postpartum depression with the use of mood and stress questionnaires (Hamilton Depression Scale, Hamilton Anxiety Scale, Perceived Stress Scale, Center for Epidemiological Studies Depression Scale) administered at 4-6 weeks postpartum, 10 weeks postpartum, and 16 weeks postpartum.
Measured: 6 weeks postpartum, 10 weeks postpartum, 16 weeks postpartum
Secondary outcomes (2)
The effect of behavioral intervention for infants on infant development
Investigators will use neurodevelopmental assessments (Bayley Scale of Infant Development, Still Face Protocol, Free Play Observation, and Conjugate Kicking Task) and cortisol reactivity to assess infant development at 4 months of age.
Measured: 4 months (infant age)
The effect of behavioral intervention on infant sleep and fuss behavior
The infant's sleep and fuss/cry behavior will be assessed at 6 weeks and 16 weeks of age (Baby Day Diary)
Measured: 6 weeks, 4 months (infant age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (60)Papers the sponsor has linked to this study.
- Other trials for Postpartum 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Robin Hood Foundation
- Responsible party
- Principal investigator, Catherine Monk, New York State Psychiatric Institute
- Investigators
- Catherine Monk, Ph.D., Principal investigator, NYPI, CUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121496
- Sponsor's protocol ID
- #6889
- Status last verified
- Jan 2020
- First submitted
- 28 Mar 2014
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Peng, S. S. High School Dropouts: A National Concern. (National Center for Education Statistics, Washington, D.C., 1985).
Markham JA, Greenough WT. Experience-driven brain plasticity: beyond the synapse. Neuron Glia Biol. 2004 Nov;1(4):351-63. doi: 10.1017/s1740925x05000219.
PubMed 16921405Nelson CA, Bloom FE. Child Development and Neuroscience. Child Dev. 1997 Oct;68(5):970-987. doi: 10.1111/j.1467-8624.1997.tb01974.x.
PubMed 29106726Whiffen VE, Gotlib IH. Infants of postpartum depressed mothers: temperament and cognitive status. J Abnorm Psychol. 1989 Aug;98(3):274-9. doi: 10.1037//0021-843x.98.3.274.
PubMed 2768663Doan SN, Evans GW. Maternal responsiveness moderates the relationship between allostatic load and working memory. Dev Psychopathol. 2011 Aug;23(3):873-80. doi: 10.1017/S0954579411000368.
PubMed 21756438Shonkoff JP, Garner AS; Committee on Psychosocial Aspects of Child and Family Health; Committee on Early Childhood, Adoption, and Dependent Care; Section on Developmental and Behavioral Pediatrics. The lifelong effects of early childhood adversity and toxic stress. Pediatrics. 2012 Jan;129(1):e232-46. doi: 10.1542/peds.2011-2663. Epub 2011 Dec 26.
PubMed 22201156Garner AS, Shonkoff JP; Committee on Psychosocial Aspects of Child and Family Health; Committee on Early Childhood, Adoption, and Dependent Care; Section on Developmental and Behavioral Pediatrics. Early childhood adversity, toxic stress, and the role of the pediatrician: translating developmental science into lifelong health. Pediatrics. 2012 Jan;129(1):e224-31. doi: 10.1542/peds.2011-2662. Epub 2011 Dec 26.
PubMed 22201148Tau GZ, Peterson BS. Normal development of brain circuits. Neuropsychopharmacology. 2010 Jan;35(1):147-68. doi: 10.1038/npp.2009.115.
PubMed 19794405Vaughn B, Egeland B, Sroufe LA, Waters E. Individual differences in infant-mother attachment at twelve and eighteen months: stability and change in families under stress. Child Dev. 1979 Dec;50(4):971-5.
PubMed 535447Sroufe LA. Psychopathology as an outcome of development. Dev Psychopathol. 1997 Spring;9(2):251-68. doi: 10.1017/s0954579497002046.
PubMed 9201444Sroufe LA. Attachment and development: a prospective, longitudinal study from birth to adulthood. Attach Hum Dev. 2005 Dec;7(4):349-67. doi: 10.1080/14616730500365928.
PubMed 16332580Meaney MJ, Diorio J, Francis D, Widdowson J, LaPlante P, Caldji C, Sharma S, Seckl JR, Plotsky PM. Early environmental regulation of forebrain glucocorticoid receptor gene expression: implications for adrenocortical responses to stress. Dev Neurosci. 1996;18(1-2):49-72. doi: 10.1159/000111395.
PubMed 8840086Meaney MJ, Szyf M, Seckl JR. Epigenetic mechanisms of perinatal programming of hypothalamic-pituitary-adrenal function and health. Trends Mol Med. 2007 Jul;13(7):269-77. doi: 10.1016/j.molmed.2007.05.003. Epub 2007 Jun 4.
PubMed 17544850Szyf M, Weaver I, Meaney M. Maternal care, the epigenome and phenotypic differences in behavior. Reprod Toxicol. 2007 Jul;24(1):9-19. doi: 10.1016/j.reprotox.2007.05.001. Epub 2007 May 10.
PubMed 17561370Grossman AW, Churchill JD, McKinney BC, Kodish IM, Otte SL, Greenough WT. Experience effects on brain development: possible contributions to psychopathology. J Child Psychol Psychiatry. 2003 Jan;44(1):33-63. doi: 10.1111/1469-7610.t01-1-00102.
PubMed 12553412
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Circumstances, Parenting Techniques, and Infant Development
- ClinicalTrials.gov ID
- NCT02121496
- Acronym / sponsor ID
- #6889
- Conditions
- Postpartum Depression, Infant Development, Rhythm; Sleep
- Keywords
- Depression, Development, Infant sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- The Robin Hood Foundation
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 23 Apr 2014 (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.
- Investigators aim to assess a novel behavioral intervention (currently approved in Protocol #6285) behavioral intervention that promotes maternally-mediated behavioral changes in young infants to reduce the risk of postpartum depression in a group of low income women. More specifically, investigators aim to determine if a behavioral intervention targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior and thereby: (1) reduce the incidence and/or severity of postpartum maternal depression in low socioeconomic status (SES) women, and (2) improve the quality of mother-infant interaction and subsequent child development. Investigators will study:
- The feasibility of applying this protocol with a low SES population
- The effectiveness of the intervention compared to usual care
- If the effects of the intervention can be detected in assessments of the quality of mother-infant interaction and infant neurocognitive development
- Investigators aim to determine whether this behavioral intervention can affect infant development as measured by neurodevelopmental assessments and cortisol reactivity at 4 months of age.
Detailed description
Developmental research consistently shows that postpartum depression has a negative impact on cognitive and emotional development during infancy and childhood. Low SES women face unique stressors and social challenges. Rates of postpartum depression are significantly higher in this group (23-33%) than in the general population (10-15%).
The purpose of this study is to understand how social circumstances, women's mood, and parenting techniques affect infant and child development. Specifically, investigators are interested in finding out whether a behavioral intervention, already being administered in IRB approved protocol #6285, targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, thereby reducing the incidence and/or severity of maternal depression and anxiety symptoms, improving the quality of the mother-infant interaction, and improving infant developmental outcomes.
By collecting stress reports from women from low SES backgrounds during pregnancy and the postpartum period and by conducting follow-up observational assessments of the quality of mother-infant interaction, infant learning, infant cortisol reactivity, and infant neurocognitive development, investigators hope to identify whether this intervention can effectively meet these aims.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resources for Postpartum Parenting | Experimental | Behavioral: Resources for Postpartum ParentingBehavioral intervention will include techniques to help mothers get their infants to cry/fuss less and sleep more to determine if this has an effect on prevalence of postpartum depression in low SES women and if it improves the quality of mother-infant interaction and subsequent child development. |
| Control Group | No intervention | –This group will not receive the coaching tips to help babies cry less and sleep more. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy pregnant women between 24 and 38 weeks gestation (based on self-report)
- Ages 18-45 (based on self-report) 3. English speaking (based on self-report)
- Salary indicated to be at New York City standardized "Struggling level" or lower - $47,700 annual for a family of 4 (based on self-report)
- Experiencing one or more of nine social adversity hardships (based on self report)
- Experiencing a healthy pregnancy, free from any significant medical complication (based on self-report)
Key exclusion criteria (5 listed)
- Multi-fetal pregnancy (based on self-report)
- Smoking, illicit drug use, or alcohol use during pregnancy (based on self-report)
- Acute medical illness or significant pregnancy complication (based on self-report)
- Currently in weekly, individual psychotherapy - group therapy and psychiatric management ok (based on self-report)
- Psychotic d/o; Bipolar I; Major Depressive d/o (based on M.I.N.I.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resources for Postpartum ParentingAlso: Practical Resources for Effective Postpartum ParentingThe intervention includes four-sessions that targets maternal caregiving of young infants to increase infant sleep and reduce fuss/cry behavior and thereby simultaneously consolidate women's enjoyment of and confidence in their maternal role, this, in turn, promotes a cycle of a mutually re- warding engagement in the mother-infant dyad - the antithesis of a 'toxic' experience, and a strong foundation for improving the chances of a successful psychosocial adjustment, including adequate employment. Investigators believe PREPP holds tremendous promise as an intervention to fill the science-practice gap in the promotion of an optimal emotional environment for the developing infant, particularly for women and children living in poverty and/or facing significant psychosocial hardship. | Behavioural | Resources for Postpartum Parenting |
Primary outcome
Change in maternal mood and prevalence/severity of postpartum depression.
Time frame: 6 weeks postpartum, 10 weeks postpartum, 16 weeks postpartum
Investigators will be assessing and tracking the incidence and/or severity of postpartum depression with the use of mood and stress questionnaires (Hamilton Depression Scale, Hamilton Anxiety Scale, Perceived Stress Scale, Center for Epidemiological Studies Depression Scale) administered at 4-6 weeks postpartum, 10 weeks postpartum, and 16 weeks postpartum.
2 secondary outcomes
The effect of behavioral intervention for infants on infant development
Time frame: 4 months (infant age)
The effect of behavioral intervention on infant sleep and fuss behavior
Time frame: 6 weeks, 4 months (infant age)
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 28 Jan 2020.
- BackgroundPeng, S. S. High School Dropouts: A National Concern. (National Center for Education Statistics, Washington, D.C., 1985).
- Background: PubMed 16921405Markham JA, Greenough WT. Experience-driven brain plasticity: beyond the synapse. Neuron Glia Biol. 2004 Nov;1(4):351-63. doi: 10.1017/s1740925x05000219.
- Background: PubMed 29106726Nelson CA, Bloom FE. Child Development and Neuroscience. Child Dev. 1997 Oct;68(5):970-987. doi: 10.1111/j.1467-8624.1997.tb01974.x.
- Background: PubMed 2768663Whiffen VE, Gotlib IH. Infants of postpartum depressed mothers: temperament and cognitive status. J Abnorm Psychol. 1989 Aug;98(3):274-9. doi: 10.1037//0021-843x.98.3.274.
- Background: PubMed 21756438Doan SN, Evans GW. Maternal responsiveness moderates the relationship between allostatic load and working memory. Dev Psychopathol. 2011 Aug;23(3):873-80. doi: 10.1017/S0954579411000368.
- Background: PubMed 22201156Shonkoff JP, Garner AS; Committee on Psychosocial Aspects of Child and Family Health; Committee on Early Childhood, Adoption, and Dependent Care; Section on Developmental and Behavioral Pediatrics. The lifelong effects of early childhood adversity and toxic stress. Pediatrics. 2012 Jan;129(1):e232-46. doi: 10.1542/peds.2011-2663. Epub 2011 Dec 26.
- Background: PubMed 22201148Garner AS, Shonkoff JP; Committee on Psychosocial Aspects of Child and Family Health; Committee on Early Childhood, Adoption, and Dependent Care; Section on Developmental and Behavioral Pediatrics. Early childhood adversity, toxic stress, and the role of the pediatrician: translating developmental science into lifelong health. Pediatrics. 2012 Jan;129(1):e224-31. doi: 10.1542/peds.2011-2662. Epub 2011 Dec 26.
- Background: PubMed 19794405Tau GZ, Peterson BS. Normal development of brain circuits. Neuropsychopharmacology. 2010 Jan;35(1):147-68. doi: 10.1038/npp.2009.115.
- Background: PubMed 535447Vaughn B, Egeland B, Sroufe LA, Waters E. Individual differences in infant-mother attachment at twelve and eighteen months: stability and change in families under stress. Child Dev. 1979 Dec;50(4):971-5.
- Background: PubMed 9201444Sroufe LA. Psychopathology as an outcome of development. Dev Psychopathol. 1997 Spring;9(2):251-68. doi: 10.1017/s0954579497002046.
- Background: PubMed 16332580Sroufe LA. Attachment and development: a prospective, longitudinal study from birth to adulthood. Attach Hum Dev. 2005 Dec;7(4):349-67. doi: 10.1080/14616730500365928.
- Background: PubMed 8840086Meaney MJ, Diorio J, Francis D, Widdowson J, LaPlante P, Caldji C, Sharma S, Seckl JR, Plotsky PM. Early environmental regulation of forebrain glucocorticoid receptor gene expression: implications for adrenocortical responses to stress. Dev Neurosci. 1996;18(1-2):49-72. doi: 10.1159/000111395.
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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.
Catherine Monk, Ph.D. principal investigator
NYPI, CUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resources for Postpartum Parenting in people with Postpartum Depression and Infant Development, run by New York State Psychiatric Institute 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 6 inclusion and 5 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 28 Jan 2020. 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?
Change in maternal mood and prevalence/severity of postpartum depression. (time frame: 6 weeks postpartum, 10 weeks postpartum, 16 weeks postpartum). 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 NCT02121496, which also lists 60 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 28 Jan 2020.