Integrating Interventions for Maternal Substance Abuse

Substance Abuse Clinical Trial

— ITSAN  

Official title:

Integrating Interventions for Maternal Substance Abuse and Child Neglect

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188434
• Other study ID #: K23DA021603
• Status: Completed
• Phase: Phase 1
• First received: August 23, 2010
• Last updated: April 27, 2015
• Start date: September 2007
• Est. completion date: August 2012

Study information

• Verified date: April 2015
• Source: Oregon Social Learning Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Child Neglect
• Substance Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• ITSAN
integrated behavioral intervention for substance abuse, parenting skills, and basic needs
• Services as Usual
Services as usual referred by child welfare

Locations

Country	Name	City	State
United States	OSLC	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Social Learning Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Addiction Severity Index	self report of all substances used	Baseline, 6 months, 12 months	No
Primary	Service Utilization Survey	self report of social, medical, and mental health services received by parent and youth	monthly	No
Primary	Parenting Measures	Assessment battery of parenting beliefs, expectations, and behaviors	Baseline, 6 months, 12 months	No
Secondary	Urinalysis	10 panel Urine Drug Screen Collection	monthly	No
Secondary	Archival data from the Child Welfare system	System level data of new reports to the child welfare system	annually	No