- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01453790
Parent Specific Depression Education and Motivation
May 24, 2017 updated by: University of California, Davis
Effectiveness of Parent Specific Depression Education and Motivation on Intent to Seek Follow-Up Care for Potential Depression Symptoms
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- UC Davis Medical Center, General Pediatrics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Parent-Specific Depression Education-Motivation
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.
|
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.
|
|
ACTIVE_COMPARATOR: General Depression Education
Mothers receive general depression education (verbal and written) which are drawn from previous research.
They also receive attention control telephone calls at 2 days.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression Follow-Up Care Seeking
Time Frame: at 2 weeks
|
Mothers' self-reported attempts at obtaining follow-up services for emotional health or depression.
|
at 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intention to Seek Depression Follow-Up Care
Time Frame: at 2 weeks
|
Three item scale measure of intention to seek care (any) for follow-up of positive depression screen.
|
at 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (ACTUAL)
October 1, 2011
Study Completion (ACTUAL)
January 1, 2012
Study Registration Dates
First Submitted
October 11, 2011
First Submitted That Met QC Criteria
October 13, 2011
First Posted (ESTIMATE)
October 18, 2011
Study Record Updates
Last Update Posted (ACTUAL)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 24, 2017
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 214808
- 214808-7 (OTHER: UC Davis)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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