Healthy Moms-Healthy Kids: Reducing Maternal Depression for Better Outcomes in Head Start Children

Sponsor

University of Southern California (Other)

Overall Status

Completed

CT.gov ID

NCT02145273

Collaborator

(none)

208

Enrollment

Locations

Arms

Duration (Months)

104

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Maternal Depression Parenting Behavior Health Interpersonal Relationships Goal Directed Behavior Child Behavior Child School Readiness	Behavioral: Interpersonal Psychotherapy for Depression -Group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

208 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

There are 3 conditions that will be followed for up to 2 years: control, intervention and comparison. Randomization is by site. Half the sites are control half are intervention. all possible subjects are screened for depression. if the subject is depressed they are invited in to control or intervention based on site, all non depressed subjects are invited into the comparison.There are 3 conditions that will be followed for up to 2 years: control, intervention and comparison. Randomization is by site. Half the sites are control half are intervention. all possible subjects are screened for depression. if the subject is depressed they are invited in to control or intervention based on site, all non depressed subjects are invited into the comparison.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Healthy Moms-Healthy Kids: Reducing Maternal Depression for Better Outcomes in Head Start Children

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Subjects screen positive for depression and are offered a group Therapy intervention for depression: Interpersonal Psychotherapy for Depression Group.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: Intervention

Subjects screen positive for depression and are offered a group Therapy intervention for depression: Interpersonal Psychotherapy for Depression Group.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Beck Depression Inventory [At entry, completion of intervention, and every 6 months for 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Institute, Inc.	Los Angeles	California	United States	90026
2	University of Southern California School of Social Work	Los Angeles	California	United States	90089