NCT01453790

Brief Summary

This project is an investigator-initiated, randomized-controlled trial of the effectiveness of written and verbal parent-specific depression education and motivational advice in increasing participants self-disclosed intention to seek follow-up care for possible depression symptoms. The control condition is written and verbal general depression education and advice. Hypothesis: the office-based experimental intervention of written and verbal parent-specific depression and emotional health education and motivational advice increases intention to seek follow-up services for emotional health or depression, when compared to written and verbal general depression education and advice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

May 30, 2017

Status Verified

June 1, 2012

Enrollment Period

6 months

First QC Date

October 11, 2011

Last Update Submit

May 24, 2017

Conditions

Keywords

depressiontreatmentmotivation to seek follow up

Outcome Measures

Primary Outcomes (1)

  • Depression Follow-Up Care Seeking

    Mothers' self-reported attempts at obtaining follow-up services for emotional health or depression.

    at 2 weeks

Secondary Outcomes (1)

  • Intention to Seek Depression Follow-Up Care

    at 2 weeks

Study Arms (2)

Parent-Specific Depression Education-Motivation

EXPERIMENTAL

Mothers receive depression education (verbal and written) with messages targeted to parent status which are drawn from previous research. They also receive motivational messages at 2 days via telephone.

Behavioral: Parent-Specific Depression Education and Motivation

General Depression Education

ACTIVE COMPARATOR

Mothers receive general depression education (verbal and written) which are drawn from previous research. They also receive attention control telephone calls at 2 days.

Behavioral: General Depression Education-Motivation

Interventions

Parent-specific written and verbal depression messages garnered from previous research were consolidated into a pamphlet and script, respectively. These are dispensed after randomization in the pediatric office. At two days, mothers in the experimental group receive a motivational telephone call.

Parent-Specific Depression Education-Motivation

General depression education messages were compiled and are delivered verbally (scripted) and written (JAMA Depression Patient Page) after randomization in the pediatric office. At 2 days, mothers in the comparison group receive an attention control telephone call.

General Depression Education

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parent of a child between the ages of 2 days and 12 years who is a patient of the UC Davis Pediatric Clinic.
  • Primary, female caregiver
  • Feeling down, depressed, or hopeless or little interest or pleasure in doing things.
  • Not currently receiving care from a mental health practitioner.
  • Comfortable speaking English without an interpreter.

You may not qualify if:

  • Parent of a child younger than 2 days or older than 12 years.
  • Dad, Foster parent, or other short term guardian.
  • Currently in treatment with a mental health practitioner.
  • Limited English Proficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center, General Pediatrics

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • Fernandez y Garcia E, Joseph J, Wilson MD, Hinton L, Simon G, Ludman E, Scott F, Kravitz RL. Pediatric-based intervention to motivate mothers to seek follow-up for depression screens: The Motivating Our Mothers (MOM) trial. Acad Pediatr. 2015 May-Jun;15(3):311-8. doi: 10.1016/j.acap.2014.11.008.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2011

First Posted

October 18, 2011

Study Start

April 1, 2011

Primary Completion

October 1, 2011

Study Completion

January 1, 2012

Last Updated

May 30, 2017

Record last verified: 2012-06

Locations