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Integrating Interventions for Maternal Substance Abuse (ITSAN)

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ClinicalTrials.gov Identifier: NCT01188434
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Substance Abuse Child Neglect Behavioral: ITSAN Behavioral: Services as Usual Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrating Interventions for Maternal Substance Abuse and Child Neglect
Study Start Date : September 2007
Primary Completion Date : June 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Addiction Severity Index [ Time Frame: Baseline, 6 months, 12 months ]
    self report of all substances used

  2. Service Utilization Survey [ Time Frame: monthly ]
    self report of social, medical, and mental health services received by parent and youth

  3. Parenting Measures [ Time Frame: Baseline, 6 months, 12 months ]
    Assessment battery of parenting beliefs, expectations, and behaviors


Secondary Outcome Measures :
  1. Urinalysis [ Time Frame: monthly ]
    10 panel Urine Drug Screen Collection

  2. Archival data from the Child Welfare system [ Time Frame: annually ]
    System level data of new reports to the child welfare system


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188434


Locations
United States, Oregon
OSLC
Eugene, Oregon, United States, 97401
Sponsors and Collaborators
Oregon Social Learning Center
Investigators
Principal Investigator: Lisa Saldana, PhD OSLC Community Programs
More Information

Responsible Party: Lisa Saldana, Research Scientist, Oregon Social Learning Center
ClinicalTrials.gov Identifier: NCT01188434     History of Changes
Other Study ID Numbers: K23DA021603 ( U.S. NIH Grant/Contract )
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015

Keywords provided by Lisa Saldana, 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