NCT02013401

Brief Summary

The central aim of this study is to assess mother-infant communication via behavioral, physiological, and affective indices under conditions where distal stressors may not be directly detectable by the infant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2016

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

December 11, 2013

Last Update Submit

October 17, 2018

Conditions

Stress

Keywords

mother-infant dyadic regulationstresspsychophysiologyemotion regulation

Outcome Measures

Primary Outcomes (1)

  • Salivary Cortisol

    Salivary cortisol is a measure that indicates hypothalamus-pituitary-adrenal axis activity. The study obtains 4 assessments with 20 minutes between each assessment. Participants chew on a cotton role for 2-minutes which is placed in a cortisol salivette tube (Sarstedt)

    One lab appointment for approximately 80 minutes.

Secondary Outcomes (1)

  • Salivary Amylase

    One lab appointment for approximately 80 minutes.

Other Outcomes (1)

  • Mother-infant observations

    One lab appointment for approximately 80 minutes.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Community sample of women (ages 18-40) with infants ages 4-9 months

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • No presence of heart murmur or wear a pacemaker
  • No medication for hypertensive or cardiovascular disease
  • Not using beta blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Mass. Boston

Boston, Massachusetts, 02125, United States

Location

University of Massachusetts, Boston, Child Development Unit

Boston, Massachusetts, 02125, United States

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Kymberlee O'Brien, PhD

    Postdoctoral Research Fellow

    PRINCIPAL INVESTIGATOR

  • Celia L Moore, PhD

    Director of DSRC and Horizon Center

    STUDY DIRECTOR

  • Edward Tronick, PhD

    Director Child Development Unit

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2013

First Posted

December 17, 2013

Study Start

October 1, 2013

Primary Completion

July 14, 2016

Study Completion

July 14, 2016

Last Updated

October 18, 2018

Record last verified: 2018-10

Locations

US(2)