NCT02938598

Brief Summary

Mothers with symptoms suggesting clinical depression can be identified and potentially motivated to seek further care during pediatric visits for their young children. The best ways for pediatric providers to encourage mothers to seek further evaluation and treatment for their depressive symptoms are not known. The investigators plan to provisionally optimize a pediatric office-based intervention that the investigators developed to motivate mothers who may be depressed to seek further care and, thereby to improve the well-being of women from diverse backgrounds and their children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

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, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2019

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

2.6 years

First QC Date

October 17, 2016

Last Update Submit

April 8, 2021

Conditions

Keywords

maternal depressionpediatric-based maternal depression screeningmaternal health services

Outcome Measures

Primary Outcomes (1)

  • Attempt to Contact a Maternal Depression Resource

    2 Weeks Post-Intervention

Secondary Outcomes (1)

  • Intention to Contact a Maternal Depression Resource

    2 Weeks Post-Intervention

Study Arms (8)

A

EXPERIMENTAL

Engagement On - Problem Solving High - Motivation On

Behavioral: Maternal Depression Education and Care-Seeking Motivation

B

EXPERIMENTAL

Engagement On - Problem Solving Low - Motivation On

Behavioral: Maternal Depression Education and Care-Seeking Motivation

C

EXPERIMENTAL

Engagement On - Problem Solving High - Motivation Off

Behavioral: Maternal Depression Education and Care-Seeking Motivation

D

EXPERIMENTAL

Engagement On - Problem Solving Low - Motivation Off

Behavioral: Maternal Depression Education and Care-Seeking Motivation

E

EXPERIMENTAL

Engagement Off - Problem Solving High - Motivation On

Behavioral: Maternal Depression Education and Care-Seeking Motivation

F

EXPERIMENTAL

Engagement Off - Problem Solving Low - Motivation On

Behavioral: Maternal Depression Education and Care-Seeking Motivation

G

EXPERIMENTAL

Engagement Off - Problem Solving High - Motivation Off

Behavioral: Maternal Depression Education and Care-Seeking Motivation

H

EXPERIMENTAL

Engagement Off - Problem Solving Low - Motivation Off

Behavioral: Maternal Depression Education and Care-Seeking Motivation

Interventions

Multicomponent behavioral and educational intervention. The investigators are only testing 3 components: Engagement, Problem-Solving, and Follow-Up Motivation

ABCDEFGH

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primarily responsible for the day-to-day care of and obtaining pediatric care for the child with which they are presenting to the pediatric clinic;
  • speak and read English or Spanish well enough to participate effectively in guided discussion;
  • positive maternal depression screen;
  • child aged 0-12 years;
  • presenting only for well-child care;
  • not currently under active and regular care for depression;
  • not previously enrolled in the study.

You may not qualify if:

  • \- unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis, Department of Pediatrics

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Erik O Fernandez y Garcia, MD MPH

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 19, 2016

Study Start

October 1, 2016

Primary Completion

May 23, 2019

Study Completion

May 23, 2019

Last Updated

April 13, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations