search
Back to results

Treatment of Maternal Depression in Home Visitation: Mother and Child Impacts (MIDISII)

Primary Purpose

Depressive Disorder in Mothers

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-Home Cognitive Behavioral Therapy
Present-Centered Therapy
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder in Mothers focused on measuring depression, psychological treatments, Cognitive Behavioral Therapy, child development, parenting, home visitation

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • first-time mother participating in home visitation program
  • enrolled in home visitation program for at least 2 months
  • 16 years of age or older
  • score of 11 or higher on Edinburgh Perinatal Depression Screen at 3 months postpartum
  • diagnosis of Major Depressive Disorder using SCID
  • English speaking

Exclusion Criteria:

  • lifetime history of bipolar disorder, schizophrenia, mental retardation, organic brain syndrome, antisocial personality disorder
  • history of psychosis
  • current substance dependence
  • current antidepressant use or other mood altering medications and/or current involvement in psychotherapy

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Present-Centered Therapy

In-Home Cognitive Behavioral Therapy

Arm Description

Mothers will receive 15 weekly sessions of PCT plus two monthly booster sessions following the 15th session.

Mothers will receive 15 weekly sessions of IH-CBT plus two booster sessions scheduled monthly following the 15th session.

Outcomes

Primary Outcome Measures

maternal depression
Maternal depression as measured by self-report, clinician rating based on semi-structured interview, and psychiatric diagnosis based on semi-structured interview.

Secondary Outcome Measures

child development and social/emotional functioning
Child developmental status based on standardized developmental assessment, and maternal report of child social/emotional functioning.

Full Information

First Posted
September 29, 2010
Last Updated
February 16, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Boston Children's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01212783
Brief Title
Treatment of Maternal Depression in Home Visitation: Mother and Child Impacts
Acronym
MIDISII
Official Title
Treatment of Maternal Depression in Home Visitation: Mother and Child Impacts
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2010 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
May 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the efficacy of In-Home Cognitive Behavioral Therapy (IH-CBT) in comparison to Present-Centered Therapy (PCT), a supportive therapeutic approach. IH-CBT is adapted form of CBT that is provided to depressed mothers participating in ongoing home visitation services. IH-CBT has been adapted to fit the setting, population, and context associated with home visiting. Mothers are recruited at 4 months postpartum. A comprehensive assessment battery is administered at pre-treatment, post-treatment, and 6, 12, and 18 months after the end of treatment. It is hypothesized that IH-CBT will be superior to PCT in decreasing depression, improving overall functioning, enhancing parenting effectiveness, and preventing relapse.
Detailed Description
Home visitation is a prevention program for sociodemographically high risk, first-time mothers and their children that is designed to optimize maternal life course and child trajectories. Research indicates that maternal depression (1) is a significant problem in home visitation with up to 45% of mothers experiencing clinically elevated symptoms while only 14% receive treatment, and (2) can significantly interfere with the efficacy of home visitation. Moreover, maternal depression negatively impacts mother-child interactions and child functioning thus potentially precluding the dyad from fully benefiting from home visitation. To address the high rate of maternal depression in existing home visitation programs, In-Home Cognitive Behavior Therapy (IH-CBT) was developed through an R34 grant as a treatment for mothers in home visitation experiencing depression postpartum. IH-CBT consists of the core features of CBT that have been adapted to address the unique needs and challenges of mothers receiving home visitation. Findings from the R34 indicate that IH-CBT is highly effective at reducing depression, with 66.7% of depressed mothers no longer obtaining a diagnosis of MDD at the end of treatment in contrast to a rate of 24.3% in mothers receiving home visitation alone. In addition, mothers receiving IH-CBT reported increased social support and reduction in other psychiatric symptoms, much of which was maintained at 3 month follow-up. This study seeks to replicate IH-CBT with a larger sample, compare the treatment to a more rigorous control condition (Present-Centered Therapy-PCT), and extend follow-up to 18 months in order to determine relapse rate. There is mixed evidence regarding the long-term effectiveness of home visitation on depressed mothers and their children-critical outcomes that, if adequately demonstrated, would significantly enhance the public health implications of home visitation. Accordingly, the study also seeks to examine the impact of IH-CBT and recovery from depression on parenting and children. Specifically, 220 mothers who are enrolled in home visitation will be recruited through initial screening and subsequent diagnosis of MDD. Subjects will be randomly assigned to IH-CBT + home visitation or PCT + home visitation. Both IH-CBT and PCT will be implemented in 15 sessions with two booster sessions provided 1 and 2 months after treatment. Measures of depression, psychiatric comorbidity, adaptive functioning, social support, parenting, and child functioning will be administered at pre-treatment, post-treatment, and at 6, 12 and 18 month follow-ups after post-treatment. It is hypothesized that IH-CBT will be superior to PCT in (1) recovery from depression, (2) risk of relapse and recurrence, and (3) increasing social support and reducing overall psychiatric symptomatology. In addition, mothers who recover from depression will show improvements in parenting and the mother-child relationship, and their children will achieve improved cognitive, social, emotional, and biologic outcomes, relative to non-recovered mothers and their offspring.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder in Mothers
Keywords
depression, psychological treatments, Cognitive Behavioral Therapy, child development, parenting, home visitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Present-Centered Therapy
Arm Type
Active Comparator
Arm Description
Mothers will receive 15 weekly sessions of PCT plus two monthly booster sessions following the 15th session.
Arm Title
In-Home Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Mothers will receive 15 weekly sessions of IH-CBT plus two booster sessions scheduled monthly following the 15th session.
Intervention Type
Behavioral
Intervention Name(s)
In-Home Cognitive Behavioral Therapy
Intervention Description
Adapted form of CBT that is delivered in the home setting, uniquely designed for young, low income new mothers, and is explicitly integrated with home visitation. IH-CBT is delivered by a masters level therapist. It consists of 15 weekly sessions and two monthly booster sessions provided after the 15th session.
Intervention Type
Behavioral
Intervention Name(s)
Present-Centered Therapy
Intervention Description
Present-Centered Therapy is a supportive psychotherapy.
Primary Outcome Measure Information:
Title
maternal depression
Description
Maternal depression as measured by self-report, clinician rating based on semi-structured interview, and psychiatric diagnosis based on semi-structured interview.
Time Frame
23 months
Secondary Outcome Measure Information:
Title
child development and social/emotional functioning
Description
Child developmental status based on standardized developmental assessment, and maternal report of child social/emotional functioning.
Time Frame
23 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: first-time mother participating in home visitation program enrolled in home visitation program for at least 2 months 16 years of age or older score of 11 or higher on Edinburgh Perinatal Depression Screen at 3 months postpartum diagnosis of Major Depressive Disorder using SCID English speaking Exclusion Criteria: lifetime history of bipolar disorder, schizophrenia, mental retardation, organic brain syndrome, antisocial personality disorder history of psychosis current substance dependence current antidepressant use or other mood altering medications and/or current involvement in psychotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert T. Ammerman, Ph.D.
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Maternal Depression in Home Visitation: Mother and Child Impacts

We'll reach out to this number within 24 hrs