- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02774525
Concurrent Treatment of Substance Abuse and Child Maltreatment
May 11, 2021 updated by: Ron Prinz, PhD, University of South Carolina
The co-occurrence of child maltreatment and parental substance-use problems is a major public health problem with serious consequences for children, parents, families, and the community at large.
The need for effective dual treatment of caregiver substance abuse and child maltreatment is unquestionable, but there is a dearth of controlled treatment outcome studies with substance-using parents who have engaged in child maltreatment.
This project examines two evidence-based treatments-Contingency Management for substance-use problems and Pathways Triple P parenting intervention to improve parenting for prevention of child-maltreatment recurrence.
These two systematic interventions are being tested in the context of traditional outpatient treatment for substance-use problems.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
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
-
-
South Carolina
-
Columbia, South Carolina, United States, 29208
- University of South Carolina Parenting & Family Res Center
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- open child protective services case for child maltreatment
- beginning intensive outpatient treatment for drug or alcohol use problem
- at least one child 2-8 years of age
Exclusion Criteria:
- not primary custodial parent for child 2-8 years of age
- serious mental illness
- residing outside the two participating counties
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: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment as Usual (TAU)
Outpatient substance-abuse treatment plus drug and alcohol screening plus brief support for personal goal setting
|
Outpatient substance-abuse therapy plus drug & alcohol screening plus support for personal goal setting
|
Experimental: Contingency Management
Contingency management for drug and alcohol abstinence plus TAU
|
Outpatient substance-abuse therapy plus drug & alcohol screening plus support for personal goal setting
Other Names:
|
Experimental: Parenting Intervention
Parenting intervention plus TAU
|
Outpatient substance-abuse therapy plus drug & alcohol screening plus support for personal goal setting
Other Names:
|
Experimental: Parenting Intervention + Contingency Management
Parenting intervention plus contingency management for drug and alcohol abstinence plus TAU
|
Outpatient substance-abuse therapy plus drug & alcohol screening plus support for personal goal setting
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
longest duration of negative urine and breath samples
Time Frame: 13 weeks
|
13 weeks
|
recurrence of child maltreatment--child protective services records
Time Frame: 18 months after baseline
|
18 months after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
self-reported substance use--Addiction Severity Index-Lite
Time Frame: 4 months after baseline; 12 months after baseline; 18 months after baseline
|
Drug and Alcohol Composite (severity)
|
4 months after baseline; 12 months after baseline; 18 months after baseline
|
parent report of child behavior problems--child behavior inventory
Time Frame: 4 months after baseline; 12 months after baseline; 18 months after baseline
|
Intensity score for child behavior problems
|
4 months after baseline; 12 months after baseline; 18 months after baseline
|
self-reported parenting--Parenting Scale; Parenting Practices Interview
Time Frame: 4 months after baseline; 12 months after baseline; 18 months after baseline
|
Parenting Scale: Overreactivity; Laxness Parenting Practices Interview: Appropriate Discipline; Harsh and Inconsistent Discipline
|
4 months after baseline; 12 months after baseline; 18 months after baseline
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
self-reported quality of life--Quality of Life Inventory
Time Frame: 4 months after baseline; 12 months after baseline; 18 months after baseline
|
4 months after baseline; 12 months after baseline; 18 months after baseline
|
self-reported HIV behavioral risk--HIV Risk Behavior Scale
Time Frame: 4 months after baseline; 12 months after baseline; 18 months after baseline
|
4 months after baseline; 12 months after baseline; 18 months after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ron Prinz, Ph.D., University of South Carolina
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
April 1, 2013
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
January 31, 2020
Study Registration Dates
First Submitted
May 10, 2016
First Submitted That Met QC Criteria
May 12, 2016
First Posted (Estimate)
May 17, 2016
Study Record Updates
Last Update Posted (Actual)
May 12, 2021
Last Update Submitted That Met QC Criteria
May 11, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00015175
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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