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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Preventing Maternal Depression In Head Start

NCT01298804

Depression

COMPLETED NA

Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

NCT04092010

Maternal Depression

RECRUITING NA

Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development

NCT03464630

Maternal Depression and Parent Practices, Postpartum Infant Development

COMPLETED NA

Interventions for Depressed Low Income Mothers and Their Infants

NCT00105573

Depression

COMPLETED NA

Prenatal Depression Prevention Effects on Parenting and Young Child Self-Regulation and Functioning

NCT04296734

Postpartum Depression Child Development Parenting +1 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Maternal Depression Parenting Behavior Health Interpersonal Relationships Goal Directed Behavior Child Behavior Child School Readiness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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

Group Type EXPERIMENTAL

Interpersonal Psychotherapy for Depression -Group

Intervention Type BEHAVIORAL

Control

Subjects screen positive for depression and are offered Treatment as usual: External referral.

Group Type NO_INTERVENTION

No interventions assigned to this group

comparison

Subjects screen negative for depression: no referral or intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Interpersonal Psychotherapy for Depression -Group

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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