search
Back to results

Concurrent Treatment of Substance Abuse and Child Maltreatment

Primary Purpose

Substance Use, Child Maltreatment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reinforcement for drug & alcohol abstinence
Parenting intervention
Treatment as usual (TAU)
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use focused on measuring child welfare system, parental substance use problem, child maltreatment, parenting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Carolina Parenting & Family Res Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Treatment as Usual (TAU)

Contingency Management

Parenting Intervention

Parenting Intervention + Contingency Management

Arm Description

Outpatient substance-abuse treatment plus drug and alcohol screening plus brief support for personal goal setting

Contingency management for drug and alcohol abstinence plus TAU

Parenting intervention plus TAU

Parenting intervention plus contingency management for drug and alcohol abstinence plus TAU

Outcomes

Primary Outcome Measures

longest duration of negative urine and breath samples
recurrence of child maltreatment--child protective services records

Secondary Outcome Measures

self-reported substance use--Addiction Severity Index-Lite
Drug and Alcohol Composite (severity)
parent report of child behavior problems--child behavior inventory
Intensity score for child behavior problems
self-reported parenting--Parenting Scale; Parenting Practices Interview
Parenting Scale: Overreactivity; Laxness Parenting Practices Interview: Appropriate Discipline; Harsh and Inconsistent Discipline

Full Information

First Posted
May 10, 2016
Last Updated
May 11, 2021
Sponsor
University of South Carolina
search

1. Study Identification

Unique Protocol Identification Number
NCT02774525
Brief Title
Concurrent Treatment of Substance Abuse and Child Maltreatment
Official Title
Concurrent Treatment of Substance Abuse and Child Maltreatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Child Maltreatment
Keywords
child welfare system, parental substance use problem, child maltreatment, parenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
Outpatient substance-abuse treatment plus drug and alcohol screening plus brief support for personal goal setting
Arm Title
Contingency Management
Arm Type
Experimental
Arm Description
Contingency management for drug and alcohol abstinence plus TAU
Arm Title
Parenting Intervention
Arm Type
Experimental
Arm Description
Parenting intervention plus TAU
Arm Title
Parenting Intervention + Contingency Management
Arm Type
Experimental
Arm Description
Parenting intervention plus contingency management for drug and alcohol abstinence plus TAU
Intervention Type
Behavioral
Intervention Name(s)
Reinforcement for drug & alcohol abstinence
Other Intervention Name(s)
Contingency management for negative drug & alcohol samples
Intervention Type
Behavioral
Intervention Name(s)
Parenting intervention
Other Intervention Name(s)
Pathways Triple P
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
Outpatient substance-abuse therapy plus drug & alcohol screening plus support for personal goal setting
Primary Outcome Measure Information:
Title
longest duration of negative urine and breath samples
Time Frame
13 weeks
Title
recurrence of child maltreatment--child protective services records
Time Frame
18 months after baseline
Secondary Outcome Measure Information:
Title
self-reported substance use--Addiction Severity Index-Lite
Description
Drug and Alcohol Composite (severity)
Time Frame
4 months after baseline; 12 months after baseline; 18 months after baseline
Title
parent report of child behavior problems--child behavior inventory
Description
Intensity score for child behavior problems
Time Frame
4 months after baseline; 12 months after baseline; 18 months after baseline
Title
self-reported parenting--Parenting Scale; Parenting Practices Interview
Description
Parenting Scale: Overreactivity; Laxness Parenting Practices Interview: Appropriate Discipline; Harsh and Inconsistent Discipline
Time Frame
4 months after baseline; 12 months after baseline; 18 months after baseline
Other Pre-specified Outcome Measures:
Title
self-reported quality of life--Quality of Life Inventory
Time Frame
4 months after baseline; 12 months after baseline; 18 months after baseline
Title
self-reported HIV behavioral risk--HIV Risk Behavior Scale
Time Frame
4 months after baseline; 12 months after baseline; 18 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Prinz, Ph.D.
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina Parenting & Family Res Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Concurrent Treatment of Substance Abuse and Child Maltreatment

We'll reach out to this number within 24 hrs