- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02145273
Healthy Moms-Healthy Kids: Reducing Maternal Depression for Better Outcomes in Head Start Children
June 7, 2019 updated by: Ferol Mennen, University of Southern California
Maternal depression is a pervasive problem that disproportionately affects low-income mothers.
The effects of depression on mothers and their parenting result in many negative outcomes for children, particularly in terms of school readiness.
The proposed research will build on a successful partnership between the University of Southern California School of Social Work (USC) and Children's Institute, Inc. (CII) to implement and evaluate an evidence-based intervention, interpersonal psychotherapy for group (IPT-G), for Head Start mothers with depression or dysphoric mood with the goal of reducing their depression and promoting positive changes for both mothers and children.
The objectives of the study are: (1) adapt IPT-G for a Head Start population of mothers with depression; (2) implement IPT-G via a randomized controlled trial in Head Start centers in Los Angeles County operated by CII; (3) evaluate the effects of the intervention on maternal depression, parenting behaviors, goal-directed behavior, interpersonal relationships, physical health, and child behavior and school readiness; and (4) develop a manual for use of the intervention in Head Start and disseminate findings nationally.
The study will feature 2 groups of 60 mothers each, randomized by Head Start site; one will receive the intervention and the other services as usual.
Outcomes for both mothers and children will be tracked for 2 years after the intervention, allowing for the evaluation of short- and long-term effects.
The intervention will be delivered by Head Start mental health workers under the supervision of Scott Stuart, a national trainer of the intervention.
This intervention has the potential to be a low-cost, high-impact intervention that can be replicated to other Head Start sites across the country to improve the lives of Head Start children and families.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
208
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
-
Los Angeles, California, United States, 90089
- University of Southern California School of Social Work
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Los Angeles, California, United States, 90026
- Children's Institute, Inc.
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-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Mothers of children in Head Start with scores on screening measure that are in depressed or possibly depressed range to be assigned to intervention or TAU. Also will have additional control group of non depressed mothers
Exclusion Criteria:
- Not able to function in group environment
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Subjects screen positive for depression and are offered a group Therapy intervention for depression: Interpersonal Psychotherapy for Depression Group.
|
|
No Intervention: Control
Subjects screen positive for depression and are offered Treatment as usual: External referral.
|
|
No Intervention: comparison
Subjects screen negative for depression: no referral or intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Beck Depression Inventory
Time Frame: At entry, completion of intervention, and every 6 months for 2 years
|
At entry, completion of intervention, and every 6 months for 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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
September 1, 2014
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
May 19, 2014
First Submitted That Met QC Criteria
May 19, 2014
First Posted (Estimate)
May 22, 2014
Study Record Updates
Last Update Posted (Actual)
June 11, 2019
Last Update Submitted That Met QC Criteria
June 7, 2019
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 90YR0074-01-00
- 90YR0074-01 (U.S. NIH Grant/Contract)
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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