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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01453790
Other study ID # 214808
Secondary ID 214808-7
Status Completed
Phase N/A
First received October 11, 2011
Last updated May 24, 2017
Start date April 2011
Est. completion date January 2012

Study information

Verified date June 2012
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Maternal depression is a common problem, debilitating for mothers and affecting parenting practices with negative effects on the behavior, development, and physical health of children. The value of identifying and treating maternal depression for child development and well-being is well documented. Unfortunately, there are multiple barriers to the recognition and treatment of maternal depression. This is particularly problematic in younger women, as they are less often seen for health care. The overall objective of this project is to test whether the uptake of follow-up recommendations for potential depression by mothers identified by screening in clinical settings is improved by parent-specific targetting of depression education and motivational advice.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date January 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Parent-Specific Depression Education and Motivation
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.
General 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.

Locations

Country Name City State
United States UC Davis Medical Center, General Pediatrics Sacramento California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Davis Children's Miracle Network

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depression Follow-Up Care Seeking Mothers' self-reported attempts at obtaining follow-up services for emotional health or depression. at 2 weeks
Secondary Intention to Seek Depression Follow-Up Care Three item scale measure of intention to seek care (any) for follow-up of positive depression screen. at 2 weeks
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