- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01212783
Treatment of Maternal Depression in Home Visitation: Mother and Child Impacts (MIDISII)
February 16, 2020 updated by: Children's Hospital Medical Center, Cincinnati
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
170
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
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
-
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
16 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Present-Centered Therapy
Mothers will receive 15 weekly sessions of PCT plus two monthly booster sessions following the 15th session.
|
Present-Centered Therapy is a supportive psychotherapy.
|
Experimental: In-Home Cognitive Behavioral Therapy
Mothers will receive 15 weekly sessions of IH-CBT plus two booster sessions scheduled monthly following the 15th session.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
maternal depression
Time Frame: 23 months
|
Maternal depression as measured by self-report, clinician rating based on semi-structured interview, and psychiatric diagnosis based on semi-structured interview.
|
23 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
child development and social/emotional functioning
Time Frame: 23 months
|
Child developmental status based on standardized developmental assessment, and maternal report of child social/emotional functioning.
|
23 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Robert T. Ammerman, Ph.D., Children's Hospital Medical Center, Cincinnati
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 (Actual)
October 1, 2010
Primary Completion (Actual)
May 30, 2017
Study Completion (Actual)
May 30, 2017
Study Registration Dates
First Submitted
September 29, 2010
First Submitted That Met QC Criteria
September 29, 2010
First Posted (Estimate)
October 1, 2010
Study Record Updates
Last Update Posted (Actual)
February 18, 2020
Last Update Submitted That Met QC Criteria
February 16, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01MH087499-01A1 (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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