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Integrating Interventions for Maternal Substance Abuse (ITSAN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Oregon Social Learning Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oregon Social Learning Center
ClinicalTrials.gov Identifier:
NCT01188434
First received: August 23, 2010
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Substance Abuse
Child Neglect
Behavioral: ITSAN
Behavioral: Services as Usual
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrating Interventions for Maternal Substance Abuse and Child Neglect

Resource links provided by NLM:


Further study details as provided by Oregon Social Learning Center:

Primary Outcome Measures:
  • Addiction Severity Index [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    self report of all substances used

  • Service Utilization Survey [ Time Frame: monthly ] [ Designated as safety issue: No ]
    self report of social, medical, and mental health services received by parent and youth

  • Parenting Measures [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Assessment battery of parenting beliefs, expectations, and behaviors


Secondary Outcome Measures:
  • Urinalysis [ Time Frame: monthly ] [ Designated as safety issue: No ]
    10 panel Urine Drug Screen Collection

  • Archival data from the Child Welfare system [ Time Frame: annually ] [ Designated as safety issue: No ]
    System level data of new reports to the child welfare system


Estimated Enrollment: 29
Study Start Date: September 2007
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188434

Contacts
Contact: Elisa Weber, LCSW 541-343-3793 ElisaW@oslc.org
Contact: Lisa Saldana, PhD 541-343-3793 ext 120 lisas@cr2p.org

Locations
United States, Oregon
OSLC Recruiting
Eugene, Oregon, United States, 97401
Contact: Elisa Weber    541-343-3793    ElisaW@oslc.org   
Contact: Lisa Saldana, PhD    541-343-3793 ext 120    lisas@cr2p.org   
Principal Investigator: Lisa Saldana, PhD         
Sponsors and Collaborators
Oregon Social Learning Center
Investigators
Principal Investigator: Lisa Saldana, PhD OSLC Community Programs
  More Information

No publications provided

Responsible Party: Lisa Saldana, Oregon Social Learning Center
ClinicalTrials.gov Identifier: NCT01188434     History of Changes
Other Study ID Numbers: K23DA21603
Study First Received: August 23, 2010
Last Updated: April 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Social Learning Center:
Methamphetamine
Substance Abuse
Child Neglect
Child Welfare
Evidence Based Practice

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014