Treatment of Depression in Mothers in Home Visitation (MIDIS)
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|ClinicalTrials.gov Identifier: NCT01221701|
Recruitment Status : Completed
First Posted : October 15, 2010
Last Update Posted : March 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder in Mothers||Behavioral: In-Home Cognitive Behavioral Psychology||Not Applicable|
This study involves the development and preliminarily testing of In-Home Cognitive Behavioral Therapy (IH-CBT), a psychological treatment grounded in the cognitive model but adapted for administration in conjunction with home visitation. IH-CBT is designed to (1) use the techniques and approaches of CBT which have received strong empirical support, (2) be implemented in the home setting, (3) meet the needs of young postpartum mothers in their first year of home visitation, and (4) be seamlessly integrated with home visitation to maximize the likelihood of recovery from depression, prevent relapse, and increase of the benefits of home visitation. IH-CBT will be delivered by trained therapist who will provide 15 treatment sessions followed by a 1 month booster session. A small-scale randomized clinical trial will be conducted contrasting IH-CBT delivered in conjunction with home visitation and home visitation alone ("typical home visitation"—THV). Mothers in the THV condition will be able to obtain treatment in the community if they choose.
Mothers will be identified based on obtaining a score of ≥12 on the Edinburgh Perinatal Depression Screen administered by home visitors at 3 months postpartum. Final eligibility will be determined based on subsequently obtaining a diagnosis of Major Depressive Disorder (MDD) using the SCID. A comprehensive assessment of depression, other psychiatric symptoms, social support and network, and parenting and child adjustment will be administered at pre-treatment, post-treatment, and 3 month follow-up. Ratings of MDD at post-treatment and follow-up will be conducted by clinicians blind to condition.
The following hypotheses will be tested:
Hypothesis 1. Mothers in IH-CBT will report greater reductions in self-reported and clinician-rated depression at post-treatment and follow up relative to THV.
Hypothesis 2. Mothers in IH-CBT will report improvements in overall functioning, social support, social network, and general psychiatric symptomatology at post-treatment and follow up relative to IH-CBT.
Hypothesis 3. Mothers who recover from depression at post-treatment will report improvements in parenting and child adjustment relative to those who do not recover.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Treatment of Depression in Mothers in Home Visitation|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||February 2013|
Experimental: In-Home Cognitive Behavioral Therapy
Mothers will receive 15 weekly sessions of IH-CBT plus one booster session scheduled 1 month later.
Behavioral: In-Home Cognitive Behavioral Psychology
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 1 booster session provided 1 month after the 15th session.
Other Name: IH-CBT
No Intervention: typical home visitation
Standard of care in home visitation in which mothers can receive treatment in the community if they choose.
- maternal depression [ Time Frame: 8 months ]Maternal depression as measured by self-report, clinician rating based on semi-structured interview, and psychiatric diagnosis based on semi-structured interview.
- parenting and child social/emotional functioning [ Time Frame: 8 months ]Maternal report of parenting stress, observation of parenting behaviors, and maternal report of child social/emotional functioning.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221701
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Robert T. Ammerman, Ph.D.||Children's Hospital Medical Center, Cincinnati|