NCT01221701

Brief Summary

This study develops and contrasts In-Home Cognitive Behavioral Therapy (IH-CBT), an adapted evidence-based treatment for depressed mothers participating in home visitation, with typical home visitation in which treatment may be obtained in the community. Mothers will be identified using a two step process consisting of administration of a screen and subsequent diagnosis of Major Depressive Disorder. The will then be randomized into the treatment and control conditions. A comprehensive assessment of depression and related areas of functioning will be administered at pre-treatment, post-treatment, and 3 month follow-up. It is hypothesized that IH-CBT will lead to broad and durable gains in mood and social support relative to those in typical home visitation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2010

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 18, 2013

Status Verified

March 1, 2013

Enrollment Period

4 years

First QC Date

October 14, 2010

Last Update Submit

March 15, 2013

Conditions

Depressive Disorder in Mothers

Keywords

depressionpsychological treatmentsCognitive Behavioral Therapychild social/emotional functioningparentinghome visitation

Outcome Measures

Primary Outcomes (1)

  • maternal depression

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

    8 months

Secondary Outcomes (1)

  • parenting and child social/emotional functioning

    8 months

Study Arms (2)

In-Home Cognitive Behavioral Therapy

EXPERIMENTAL

Mothers will receive 15 weekly sessions of IH-CBT plus one booster session scheduled 1 month later.

Behavioral: In-Home Cognitive Behavioral Psychology

typical home visitation

NO INTERVENTION

Standard of care in home visitation in which mothers can receive treatment in the community if they choose.

Interventions

In-Home Cognitive Behavioral PsychologyBEHAVIORAL

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.

Also known as: IH-CBT
In-Home Cognitive Behavioral Therapy

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • first-time mother participating in home visitation program
  • enrolled in home visitation program for at least 2 months
  • years of age or older
  • score of 12 or higher on Edinburgh Perinatal Depression Screen at 3 months postpartum
  • diagnosis of Major Depressive Disorder using the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders
  • English speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (2)

  • Ammerman RT, Putnam FW, Bosse NR, Teeters AR, Van Ginkel JB. Maternal Depression in Home Visitation: A Systematic Review. Aggress Violent Behav. 2010 May;15(3):191-200. doi: 10.1016/j.avb.2009.12.002.

    PMID: 20401324BACKGROUND

  • Ammerman RT, Putnam FW, Stevens J, Bosse NR, Short JA, Bodley AL, Van Ginkel JB. An open trial of in-home CBT for depressed mothers in home visitation. Matern Child Health J. 2011 Nov;15(8):1333-41. doi: 10.1007/s10995-010-0691-7.

    PMID: 20936338BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Robert T. Ammerman, Ph.D.

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2010

First Posted

October 15, 2010

Study Start

October 1, 2006

Primary Completion

October 1, 2010

Study Completion

February 1, 2013

Last Updated

March 18, 2013

Record last verified: 2013-03

Locations

US(1)