Integrating Interventions for Maternal Substance Abuse (ITSAN)

April 27, 2015 updated by: Lisa Saldana, Oregon Social Learning Center

Integrating Interventions for Maternal Substance Abuse and Child Neglect

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integrated Behavioral Treatment
Combined substance abuse, parenting skills, and basic needs intervention
Behavioral: ITSAN
integrated behavioral intervention for substance abuse, parenting skills, and basic needs
Active Comparator: casework treatment as usual
services as usual as referred by child welfare
Behavioral: Services as Usual
Services as usual referred by child welfare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Addiction Severity Index
Time Frame: Baseline, 6 months, 12 months
self report of all substances used
Baseline, 6 months, 12 months
Service Utilization Survey
Time Frame: monthly
self report of social, medical, and mental health services received by parent and youth
monthly
Parenting Measures
Time Frame: Baseline, 6 months, 12 months
Assessment battery of parenting beliefs, expectations, and behaviors
Baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinalysis
Time Frame: monthly
10 panel Urine Drug Screen Collection
monthly
Archival data from the Child Welfare system
Time Frame: annually
System level data of new reports to the child welfare system
annually

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Social Learning Center

Investigators

  • Principal Investigator: Lisa Saldana, PhD, OSLC Community Programs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

August 23, 2010

First Submitted That Met QC Criteria

August 23, 2010

First Posted (Estimate)

August 25, 2010

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23DA021603 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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