NCT01129752

Brief Summary

The purpose of this study is to investigate risk factors associated with depression and how such factors might be transmitted cross-generationally. The investigators are conducting an integrative assessment of emotion regulation and stress reactivity in a group of mothers with and without a history of depression and their daughters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2004

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

7.2 years

First QC Date

May 21, 2010

Last Update Submit

June 21, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Onset of depression

    participants are interviewed in an 18-month follow-up session

    18 months

Study Arms (1)

children at risk for depression

children at familial risk for depression

Other: No intervention

Interventions

there is no intervention for this study

children at risk for depression

Eligibility Criteria

Age9 Years - 15 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Eligible mothers must read and speak English fluently and have a child between the ages of 9 and 15 years old. Mothers must either have no history of psychopathology or have a history of depression during their child's lifetime.

You may qualify if:

  • Eligible mothers must read and speak English fluently and have a child between the ages of 9 and 15 years old.
  • Mothers must either have no history of psychopathology or have a history of depression during their child's lifetime.

You may not qualify if:

  • Eligible mothers cannot:
  • currently be in treatment for drug or alcohol abuse
  • have significant symptomatology related to psychopathology outside of depression
  • have a medical history of neurological injury or impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University Department of Psychology

Stanford, California, 94305, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

All participants are asked to submit saliva samples during their second session using sterile salivette containers in order to assess cortisol levels. There is no risk involved in giving these samples.

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Ian H Gotlib, PhD

    Stanford University Department of Psychology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 21, 2010

First Posted

May 25, 2010

Study Start

February 1, 2004

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations