ID

36436

Description

Treatment of Maternal Depression in Home Visitation: Mother and Child Impacts; ODM derived from: https://clinicaltrials.gov/show/NCT01212783 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.

Link

https://clinicaltrials.gov/show/NCT01212783

Keywords

Versions (2)
  1. 1/16/19 1/16/19 -
  2. 5/14/19 5/14/19 -
Copyright Holder

Children's Hospital Medical Center, Cincinnati

Uploaded on

May 14, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Maternal Depression in Home Visitation Treatment NCT01212783

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Is the participant a first-time mother participating in a home visitation program?
Description

First time mother and home visitation program

Data type

boolean

Alias
UMLS CUI [1,1]
C0026591
UMLS CUI [1,2]
C1279901
UMLS CUI [1,3]
C0679823
UMLS CUI [1,4]
C0020043
UMLS CUI [1,5]
C3484370
Is the participant enrolled in home visitation program for at least 2 months?
Description

Participants have to be enrolled in home visitation program for at least 2 months

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0020043
UMLS CUI [1,4]
C3484370
Is the patient 16 years of age or older?
Description

Patients have to be have to be 16 years of age or older

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Does the participant have a score of 11 or higher on edinburgh perinatal depression screen at 3 months postpartum?
Description

Edinburgh Perinatal Depression Score

Data type

boolean

Alias
UMLS CUI [1]
C0451144
Does the participant have a diagnosis of major depressive disorder using SCID?
Description

Major Depressive Disorder (SCID)

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C1537054
Does the participant speak english?
Description

Participants have to be english speaking

Data type

boolean

Alias
UMLS CUI [1,1]
C1145677
UMLS CUI [1,2]
C0376245
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Does the patient have a lifetime history of bipolar disorder, schizophrenia, mental retardation, organic brain syndrome or antisocial personality disorder?
Description

A lifetime history of bipolar disorder, schizophrenia, mental retardation, organic brain syndrome, antisocial personality disorder leads to exclusion as this would confound the analysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0005586
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0036341
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0025362
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C0029221
UMLS CUI [5,1]
C0262926
UMLS CUI [5,2]
C0003431
Does the patient have a history of psychosis?
Description

Psychosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0033975
UMLS CUI [1,2]
C0262926
Does the particpant currently have substance dependence?
Description

Current Substance Dependence

Data type

boolean

Alias
UMLS CUI [1,1]
C0038580
UMLS CUI [1,2]
C0521116
Does the participant have current antidepressant use or other mood altering medications and/or current involvement in psychotherapy?
Description

Confounding Psychiatric Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0003289
UMLS CUI [2,1]
C0521116
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0392747
UMLS CUI [2,4]
C0026516
UMLS CUI [3,1]
C0521116
UMLS CUI [3,2]
C0033968
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
First time mother and home visitation program
Item
Is the participant a first-time mother participating in a home visitation program?
boolean
C0026591 (UMLS CUI [1,1])
C1279901 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
C0020043 (UMLS CUI [1,4])
C3484370 (UMLS CUI [1,5])
Enrollment duration
Item
Is the participant enrolled in home visitation program for at least 2 months?
boolean
C1516879 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0020043 (UMLS CUI [1,3])
C3484370 (UMLS CUI [1,4])
Age
Item
Is the patient 16 years of age or older?
boolean
C0001779 (UMLS CUI [1])
Edinburgh Perinatal Depression Score
Item
Does the participant have a score of 11 or higher on edinburgh perinatal depression screen at 3 months postpartum?
boolean
C0451144 (UMLS CUI [1])
Major Depressive Disorder (SCID)
Item
Does the participant have a diagnosis of major depressive disorder using SCID?
boolean
C1269683 (UMLS CUI [1,1])
C1537054 (UMLS CUI [1,2])
Language
Item
Does the participant speak english?
boolean
C1145677 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Confounding psychiatric disorders
Item
Does the patient have a lifetime history of bipolar disorder, schizophrenia, mental retardation, organic brain syndrome or antisocial personality disorder?
boolean
C0262926 (UMLS CUI [1,1])
C0005586 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0025362 (UMLS CUI [3,2])
C0262926 (UMLS CUI [4,1])
C0029221 (UMLS CUI [4,2])
C0262926 (UMLS CUI [5,1])
C0003431 (UMLS CUI [5,2])
Psychosis
Item
Does the patient have a history of psychosis?
boolean
C0033975 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Current Substance Dependence
Item
Does the particpant currently have substance dependence?
boolean
C0038580 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Confounding Psychiatric Treatment
Item
Does the participant have current antidepressant use or other mood altering medications and/or current involvement in psychotherapy?
boolean
C0521116 (UMLS CUI [1,1])
C0003289 (UMLS CUI [1,2])
C0521116 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0026516 (UMLS CUI [2,4])
C0521116 (UMLS CUI [3,1])
C0033968 (UMLS CUI [3,2])
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