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

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

Sponsors

Lead sponsor: Children's Hospital Medical Center, Cincinnati

Collaborator: Boston Children’s Hospital

Source Children's Hospital Medical Center, Cincinnati
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.

Overall Status Completed
Start Date October 2010
Completion Date May 30, 2017
Primary Completion Date May 30, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
maternal depression 23 months
Secondary Outcome
Measure Time Frame
child development and social/emotional functioning 23 months
Enrollment 170
Condition
Intervention

Intervention type: Behavioral

Intervention name: In-Home Cognitive Behavioral Therapy

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.

Arm group label: In-Home Cognitive Behavioral Therapy

Intervention type: Behavioral

Intervention name: Present-Centered Therapy

Description: Present-Centered Therapy is a supportive psychotherapy.

Arm group label: Present-Centered Therapy

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

Gender: Female

Minimum age: 16 Years

Maximum age: 45 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Robert T. Ammerman, Ph.D. Principal Investigator Children's Hospital Medical Center, Cincinnati
Location
facility
Cincinnati Children's Hospital Medical Center
Location Countries

United States

Verification Date

February 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Present-Centered Therapy

Arm group type: Active Comparator

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

Arm group label: In-Home Cognitive Behavioral Therapy

Arm group type: Experimental

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

Acronym MIDISII
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov