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Integrating Interventions for Maternal Substance Abuse (ITSAN)

Primary Purpose

Substance Abuse, Child Neglect

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ITSAN
Services as Usual
Sponsored by
Oregon Social Learning Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Methamphetamine, Substance Abuse, Child Neglect, Child Welfare, Evidence Based Practice

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Maternal Substance Abuse
  • Child Welfare involvement
  • Child Neglect
  • English Speaking
  • Child either remaining in the home or reunification plan in place
  • Living in the county

Exclusion Criteria:

  • Current involvement in other substance abuse treatment
  • Current involvement in other parenting skills training
  • parental rights terminated
  • active psychosis

Sites / Locations

  • OSLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Integrated Behavioral Treatment

casework treatment as usual

Arm Description

Combined substance abuse, parenting skills, and basic needs intervention

services as usual as referred by child welfare

Outcomes

Primary Outcome Measures

Addiction Severity Index
self report of all substances used
Service Utilization Survey
self report of social, medical, and mental health services received by parent and youth
Parenting Measures
Assessment battery of parenting beliefs, expectations, and behaviors

Secondary Outcome Measures

Urinalysis
10 panel Urine Drug Screen Collection
Archival data from the Child Welfare system
System level data of new reports to the child welfare system

Full Information

First Posted
August 23, 2010
Last Updated
April 27, 2015
Sponsor
Oregon Social Learning Center
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1. Study Identification

Unique Protocol Identification Number
NCT01188434
Brief Title
Integrating Interventions for Maternal Substance Abuse
Acronym
ITSAN
Official Title
Integrating Interventions for Maternal Substance Abuse and Child Neglect
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Social Learning Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This Research Plan proposes Stage 1 Research integrating evidence based practices to address the needs of mothers referred to child welfare for substance abuse. Mothers with a history of methamphetamine abuse and child neglect will be recruited. Using an intensive community based treatment, mothers will receive substance abuse treatment combined with parenting skills training and psychosocial support for basic needs (e.g., housing, employment). This project will include a feasibility study (n = 5), followed by a small randomized pilot (n = 24) to examine the efficacy of the Integrated Treatment for Substance Abuse and Neglect compared to treatment as usual, with a population of substance abusing neglectful mothers referred through the Department of Child Welfare.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Child Neglect
Keywords
Methamphetamine, Substance Abuse, Child Neglect, Child Welfare, Evidence Based Practice

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated Behavioral Treatment
Arm Type
Experimental
Arm Description
Combined substance abuse, parenting skills, and basic needs intervention
Arm Title
casework treatment as usual
Arm Type
Active Comparator
Arm Description
services as usual as referred by child welfare
Intervention Type
Behavioral
Intervention Name(s)
ITSAN
Intervention Description
integrated behavioral intervention for substance abuse, parenting skills, and basic needs
Intervention Type
Behavioral
Intervention Name(s)
Services as Usual
Intervention Description
Services as usual referred by child welfare
Primary Outcome Measure Information:
Title
Addiction Severity Index
Description
self report of all substances used
Time Frame
Baseline, 6 months, 12 months
Title
Service Utilization Survey
Description
self report of social, medical, and mental health services received by parent and youth
Time Frame
monthly
Title
Parenting Measures
Description
Assessment battery of parenting beliefs, expectations, and behaviors
Time Frame
Baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Urinalysis
Description
10 panel Urine Drug Screen Collection
Time Frame
monthly
Title
Archival data from the Child Welfare system
Description
System level data of new reports to the child welfare system
Time Frame
annually

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Maternal Substance Abuse Child Welfare involvement Child Neglect English Speaking Child either remaining in the home or reunification plan in place Living in the county Exclusion Criteria: Current involvement in other substance abuse treatment Current involvement in other parenting skills training parental rights terminated active psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Saldana, PhD
Organizational Affiliation
OSLC Community Programs
Official's Role
Principal Investigator
Facility Information:
Facility Name
OSLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Integrating Interventions for Maternal Substance Abuse

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