NCT01188434

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

4.8 years

First QC Date

August 23, 2010

Last Update Submit

April 27, 2015

Conditions

Keywords

MethamphetamineSubstance AbuseChild NeglectChild WelfareEvidence Based Practice

Outcome Measures

Primary Outcomes (3)

  • Addiction Severity Index

    self report of all substances used

    Baseline, 6 months, 12 months

  • Service Utilization Survey

    self report of social, medical, and mental health services received by parent and youth

    monthly

  • Parenting Measures

    Assessment battery of parenting beliefs, expectations, and behaviors

    Baseline, 6 months, 12 months

Secondary Outcomes (2)

  • Urinalysis

    monthly

  • Archival data from the Child Welfare system

    annually

Study Arms (2)

Integrated Behavioral Treatment

EXPERIMENTAL

Combined substance abuse, parenting skills, and basic needs intervention

Behavioral: ITSAN

casework treatment as usual

ACTIVE COMPARATOR

services as usual as referred by child welfare

Behavioral: Services as Usual

Interventions

ITSANBEHAVIORAL

integrated behavioral intervention for substance abuse, parenting skills, and basic needs

Integrated Behavioral Treatment

Services as usual referred by child welfare

casework treatment as usual

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OSLC

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Lisa Saldana, PhD

    OSLC Community Programs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

August 23, 2010

First Posted

August 25, 2010

Study Start

September 1, 2007

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

April 29, 2015

Record last verified: 2015-04

Locations