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

NCT02145273 | Completed

• 2 other identifiers: 90YR0074-01-0090YR0074-01
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Maternal Depression; Interpersonal Psychotherapy; School Readiness

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory

  At entry, completion of intervention, and every 6 months for 2 years

Study Arms (3)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

comparison

NO INTERVENTION

Subjects screen negative for depression: no referral or intervention.

Interventions

Interpersonal Psychotherapy for Depression -Group BEHAVIORAL

Intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not able to function in group environment

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (2)

Children's Institute, Inc.

Los Angeles, California, 90026, United States

Location

University of Southern California School of Social Work

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Child Behavior

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 22, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: June 11, 2019

Record last verified: 2017-04

Locations

US (2)