Family-Based Treatment for Parental Substance Abuse and Child Maltreatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01656837
First received: August 1, 2012
Last updated: June 17, 2013
Last verified: June 2012
  Purpose

Parental substance abuse is a leading determinant of child maltreatment and, consequently, is often linked with negative clinical outcomes for children, exorbitant financial costs for the child welfare system, and serious social costs for the investigators nation. Yet, in spite of the seriousness of child maltreatment in the context of parental substance abuse and that there are well-established effective treatments for adult substance abuse, substance-abusing parents in the child welfare system are less likely to be offered services and receive services. Well-integrated treatments for the dual problem of substance abuse and child maltreatment are virtually nonexistent in the research literature. This study is a randomized controlled trial comparing Comprehensive Community Treatment to Multisystemic Therapy-Building Stronger Families (MST-BSF), an integrated model of two evidence-based treatments for parental substance abuse and child maltreatment that has shown promise in a 4-year pilot.

Statement of Study Hypothesis:

Compared to Comprehensive Community Treatment, parents receiving MST-BSF will show greater reductions in parental substance abuse and psychological distress, greater increases in employment, drug-free activities, social support, and positive parenting, and fewer incidents of reabuse of a child. Children whose families receive MST-BSF will experience fewer child out-of-home placements and greater reductions in internalizing symptoms such as anxiety.


Condition Intervention
Substance Abuse
Child Abuse
Child Neglect
Behavioral: Comprehensive Community Treatment
Behavioral: MST-BSF

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Family-Based Treatment for Parental Substance Abuse and Child Maltreatment

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Parental Substance Abuse [ Time Frame: 18 months post baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Abuse of a child [ Time Frame: 18 months post baseline ] [ Designated as safety issue: No ]
    physical abuse and/or neglect


Other Outcome Measures:
  • Child Out-of-Home Placement [ Time Frame: 18 months post baseline ] [ Designated as safety issue: No ]
  • Parental Psychological Distress [ Time Frame: 18 months post baseline ] [ Designated as safety issue: No ]
  • Child Internalizing Symptoms [ Time Frame: 18 months post baseline ] [ Designated as safety issue: No ]
    Anxiety, Depression, Post-Traumatic Stress Disorder Symptoms

  • Abusive Parenting [ Time Frame: 18 months post baseline ] [ Designated as safety issue: No ]
    physical assault, psychological aggression, neglectful parenting

  • Parental Social Support [ Time Frame: 18 months post baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: April 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MST-BSF
MST-BSF integrates two models with empirical support for their effectiveness, MST-CAN for child maltreatment (Swenson, Schaeffer, Henggeler, Faldowski, & Mayhew, 2012) and RBT for adult substance abuse (Tuten, Jones, Schaeffer, Wong, & Stitzer, 2012) into one comprehensive treatment package. MST-BSF is intended to be comprehensive. The major interventions within the MST-BSF arm include safety planning and implementation, functional analysis of the abuse incident, cognitive behavioral interventions for PTSD symptomatology and low anger management, family communication and problem solving, abuse clarification, and Reinforcement Based Treatment for adult substance abuse. RBT is an incentive-based drug treatment program for adults who abuse opiates, cocaine, or other illicit drugs.
Behavioral: MST-BSF
Experimental: Comprehensive Community Treatment
Families randomized to the CCT condition receive an array of services consistent with existing DCF practices. Project Safe community providers offer individual, couples, and family therapy for substance abuse/dependence, early intervention groups, treatment for co-occurring disorders, gender-specific trauma/substance abuse groups, and relapse prevention groups. The DCF caseworker also is responsible for coordinating care for the behavioral and mental health needs of the children. Services include individual outpatient treatment, family therapy, intensive in-home treatment, extended day programs, intensive outpatient, partial and inpatient hospitalization, residential programs/temporary housing (safe homes, shelters), emergency mobile psychiatric services, and crisis stabilization.
Behavioral: Comprehensive Community Treatment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • An allegation of parental physical abuse and/or neglect of a child was received by DCF child protective services, and DCF has decided that the information collected is sufficient to conclude that maltreatment occurred.
  • The report of physical abuse and/or neglect came to DCF child protective services within the past 180 days.
  • The maltreating parent met diagnostic criteria for a substance abuse disorder as assessed with the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I/P; First, Spitzer, Gibbon, & Williams, 2002).
  • The maltreated child was between the ages of 6 and 17 years.

Exclusion Criteria:

Families will be excluded if either of these criteria are met:

  • Child protective services has a confirmed report of current and ongoing physical or sexual violence by one parent or caregiver toward another parent or caregiver (i.e., active domestic violence).
  • Child protective services has a confirmed report that a child in the home is actively being sexually abused by a parent or caregiver who is in the home (i.e., active child sexual abuse).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656837

Contacts
Contact: Cindy M. Schaeffer, Ph.D. 410-258-0695 schaeffc@musc.edu
Contact: Cynthia C Swenson, Ph.D. 843-876-1802 swensocc@musc.edu

Locations
United States, Connecticut
Connecticut Department of Children and Families Recruiting
New Britain, Connecticut, United States, 06051
Contact: Melissa Sienna, MS    860-560-3698    melissa.sienna@ct.gov   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Cynthia C Swenson, Ph.D. Medical University of South Carolina
Principal Investigator: Cindy M Schaeffer, Ph.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01656837     History of Changes
Other Study ID Numbers: 5R01DA029726-02
Study First Received: August 1, 2012
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Substance Abuse
Child Maltreatment
Multisystemic Therapy
Child Trauma

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 02, 2014