NCT02774525

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

6.8 years

First QC Date

May 10, 2016

Last Update Submit

May 11, 2021

Conditions

Keywords

child welfare systemparental substance use problemchild maltreatmentparenting

Outcome Measures

Primary Outcomes (2)

  • longest duration of negative urine and breath samples

    13 weeks

  • recurrence of child maltreatment--child protective services records

    18 months after baseline

Secondary Outcomes (3)

  • self-reported substance use--Addiction Severity Index-Lite

    4 months after baseline; 12 months after baseline; 18 months after baseline

  • parent report of child behavior problems--child behavior inventory

    4 months after baseline; 12 months after baseline; 18 months after baseline

  • self-reported parenting--Parenting Scale; Parenting Practices Interview

    4 months after baseline; 12 months after baseline; 18 months after baseline

Other Outcomes (2)

  • self-reported quality of life--Quality of Life Inventory

    4 months after baseline; 12 months after baseline; 18 months after baseline

  • self-reported HIV behavioral risk--HIV Risk Behavior Scale

    4 months after baseline; 12 months after baseline; 18 months after baseline

Study Arms (4)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Behavioral: Treatment as usual (TAU)

Contingency Management

EXPERIMENTAL

Contingency management for drug and alcohol abstinence plus TAU

Behavioral: Reinforcement for drug & alcohol abstinenceBehavioral: Treatment as usual (TAU)

Parenting Intervention

EXPERIMENTAL

Parenting intervention plus TAU

Behavioral: Parenting interventionBehavioral: Treatment as usual (TAU)

Parenting Intervention + Contingency Management

EXPERIMENTAL

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

Behavioral: Reinforcement for drug & alcohol abstinenceBehavioral: Parenting interventionBehavioral: Treatment as usual (TAU)

Interventions

Also known as: Contingency management for negative drug & alcohol samples
Contingency ManagementParenting Intervention + Contingency Management
Also known as: Pathways Triple P
Parenting InterventionParenting Intervention + Contingency Management

Outpatient substance-abuse therapy plus drug \& alcohol screening plus support for personal goal setting

Contingency ManagementParenting InterventionParenting Intervention + Contingency ManagementTreatment as Usual (TAU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • not primary custodial parent for child 2-8 years of age
  • serious mental illness
  • residing outside the two participating counties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina Parenting & Family Res Center

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Pharmaceutical PreparationsEthanolTherapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Ron Prinz, Ph.D.

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Carolina Distinguished Professor

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 17, 2016

Study Start

April 1, 2013

Primary Completion

December 31, 2019

Study Completion

January 31, 2020

Last Updated

May 12, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations