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Behavioral Change in the Mother-Infant Dyad: Preventing Postpartum Depression

Behavioral Change in the Mother-Infant Dyad: Preventing Postpartum Depression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01379781
Enrollment
54
Registered
2011-06-23
Start date
2011-08-31
Completion date
2018-02-28
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Depression

Keywords

prevention, postpartum depression

Brief summary

Postpartum depression (PPD) is undertreated and the consequences of this are substantial for women and children. Studies show that infant cry/fuss and sleep behavior are associated with PPD, and that parenting interventions can change infant behavior, yet these findings have never been applied to PPD. In this study, the investigators are teaching parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to women likely to develop PPD to see if the investigators can prevent the onset of this disorder.

Detailed description

Of the over 4 million live births each year in the United States, nearly 800,000 - or 20% - of the mothers will develop major or minor depression within the first 3 months postpartum. This number dwarfs prevalence rates for gestational diabetes (2-5%) and preterm birth (12.7%). Existing clinical approaches to postpartum depression (PPD) use standard pharmacologic and psychological interventions to reduce women's symptoms. Nevertheless, PPD is undertreated, in part because women are reluctant to seek treatment due to stigma associated with mental health care and disinclination to take psychotropic medications when breastfeeding. The consequences of this are substantial. Untreated PPD is associated with diminished quality of life and significant emotional suffering for women, and, through compromised caregiving, poor outcomes in children's cognitive and social-emotional development. Although maternal risk factors for PPD are well known, protocols for prevention based on commonly used depression interventions are only beginning to be evaluated. Building on developmental data showing the profound bi-directionality of emotional and behavioral influences between mother and infant, the investigators are testing a novel PPD intervention protocol that challenges the standard, individually-focused treatment paradigm. Our intervention is based on the conceptualization of PPD as a potential disorder of the dyad, and one that can be approached through behavioral change in and affective engagement with mother and child. Studies show that infant cry/fuss and sleep behavior are associated with PPD, and that parenting interventions can change infant behavior, yet these findings have never been applied to PPD. The investigators aim to collect data on a novel PPD risk-reducing protocol based on a dyadic behavioral approach to PPD in which the investigators treat at-risk women by promoting maternally-mediated behavioral changes in their infants. The investigators will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits, then evaluate infant behavior at 6 and 14 weeks, and maternal mood at 6, 10, and 14 weeks postpartum. The investigators will fully exploit the investigative opportunities of this intervention study by using state-of-the-art EEG and fetal monitoring to characterize early biomarkers associated with infant behavior and behavior change. This study has the potential to have a major impact on clinical research, and to transform the standard care of PPD in that (1) the intervention will have high rates of treatment compliance because (a) the protocol sessions can be incorporated into usual perinatal medical visits, (b) parenting skills will appeal to women as a non-psychiatric intervention, (c) the clinical approach will have face validity given the dyadic focus of the perinatal period; (2) its aim is prevention; (3) it fosters both maternal and child well being; (4) it will expand the risk factors for PPD to include neurobehavioral markers in the perinate.

Interventions

BEHAVIORALBehavioral Intervention for PPD

We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits.

Sponsors

New York State Psychiatric Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy, non-smoking pregnant women * Ages 18-35 * Score of 28 or higher on the Predictive Index of Postnatal Depression * Low to normal obstetric risk * Before 34 weeks gestation

Exclusion criteria

* High Risk pregnancy * Taking medications that affect the cardiovascular system (α blockers, β blockers, corticosteroids * Chronic-use asthma medications (e.g. beta2-adrenoceptor agonists) * Smoking during pregnancy * Illicit drug/alcohol use during pregnancy * Taking any psychotropic medications

Design outcomes

Primary

MeasureTime frameDescription
Hamilton Rating Scales of Depression6 weeks postpartum* Assessing severity of depression; clinician rated * 24 questions * 13 items are scored on a 5 point scale ranging from 0=not present to 4=severe * 11 items are scored from 0-2 * A composite score is created by the sum of the scores from all items. Scores can range from 0-74 * 0-7: normal * 8-13: mild depression * 14-18: moderate depression * 19-23: severe depression * 24: very severe depression * Higher summed values indicate a greater severity of depression

Countries

United States

Participant flow

Recruitment details

Recruitment took place between July 2011 and November 2013 at Columbia University Medical Center.

Pre-assignment details

All enrolled participants were randomized.

Participants by arm

ArmCount
Behavioral Intervention for PPD
Behavioral Intervention for PPD delivered over 3 in-person sessions. Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits.
27
Treatment As Usual
Referred to Treatment in the Community. Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits.
27
Total54

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up118

Baseline characteristics

CharacteristicBehavioral Intervention for PPDTotalTreatment As Usual
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
27 Participants54 Participants27 Participants
Age, Continuous30.87 years
STANDARD_DEVIATION 6.51
30.24 years
STANDARD_DEVIATION 6.09
29.60 years
STANDARD_DEVIATION 5.67
Ethnicity (NIH/OMB)
Hispanic or Latino
15 Participants31 Participants16 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants20 Participants10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants3 Participants1 Participants
Hamilton Rating Scales of Depression18.48 units on a scale
STANDARD_DEVIATION 12.82
16.16 units on a scale
STANDARD_DEVIATION 15
13.83 units on a scale
STANDARD_DEVIATION 17.17
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants4 Participants2 Participants
Race (NIH/OMB)
Black or African American
4 Participants10 Participants6 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
16 Participants33 Participants17 Participants
Race (NIH/OMB)
White
4 Participants6 Participants2 Participants
Region of Enrollment
United States
27 participants54 participants27 participants
Sex: Female, Male
Female
27 Participants54 Participants27 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 270 / 27
serious
Total, serious adverse events
0 / 270 / 27

Outcome results

Primary

Hamilton Rating Scales of Depression

* Assessing severity of depression; clinician rated * 24 questions * 13 items are scored on a 5 point scale ranging from 0=not present to 4=severe * 11 items are scored from 0-2 * A composite score is created by the sum of the scores from all items. Scores can range from 0-74 * 0-7: normal * 8-13: mild depression * 14-18: moderate depression * 19-23: severe depression * 24: very severe depression * Higher summed values indicate a greater severity of depression

Time frame: 6 weeks postpartum

Population: Those in the analysis received both baseline and 6-week assessment sessions.

ArmMeasureValue (MEAN)Dispersion
Behavioral Intervention for PPDHamilton Rating Scales of Depression12.09 units on a scaleStandard Deviation 7.31
Treatment As UsualHamilton Rating Scales of Depression17.17 units on a scaleStandard Deviation 9.81
Comparison: Mixed effect model was used to compare Hamilton Rating Scales of Depression (HRSD) for women who received the PREPP intervention between the pre-randomization assessment and the 6 weeks postpartum session.p-value: 0.01Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026