- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01656837
Family-Based Treatment for Parental Substance Abuse and Child Maltreatment
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Parental substance abuse is a leading determinant of child maltreatment and, consequently, is often linked with detrimental clinical outcomes for children (e.g., short- and long-term mental health and substance abuse problems), exorbitant fiscal costs for the child welfare system (e.g., investigation, monitoring, court time, and out-of-home placements for child victims), and serious social costs for our nation (e.g., many children are removed from their communities and become long-term wards of the state; families often disintegrate as parental substance abuse continues). Yet, in spite of the gravity of child maltreatment in the context of parental substance abuse, substance abusing parents rarely receive evidence-based treatments for their problems. Rather, such parents are usually referred from the child welfare system to the adult substance abuse system where, unfortunately, they are seldom provided the outreach needed for treatment engagement nor the intensity and breadth of services needed to place these parents and families on more productive life trajectories.
Four years ago, at the behest of the Connecticut Department of Children and Families (DCF) and with the support of the Annie E. Casey Foundation, the investigators developed a comprehensive community-based treatment program to address the problem of co-occurring parental substance abuse and child maltreatment. Importantly, and in collaboration with investigators at the Johns Hopkins University, this program, named "Multisystemic Therapy-Building Stronger Families" (MST-BSF), integrated an innovative evidence-based treatment for adult substance abuse, Reinforcement-Based Treatment (RBT; Tuten, Jones, Schaeffer, Wong, & Stitzer, 2012)with an evidence-based treatment of child abuse and neglect called Multisystemic Therapy for Child Abuse and Neglect (MST-CAN; Swenson, Schaeffer, Henggeler, Faldowski, & Mayhew, 2010). As discussed elsewhere (Swenson, Schaeffer, Tuerk, et al., 2009), these two evidence-based approaches include key conceptual (e.g., ecological view of behavior, commitment to empirical validation) and clinical (e.g., use of behavioral intervention techniques) similarities that have facilitated their smooth integration into a coherent clinical model - with all relevant substance abuse and maltreatment services provided by therapists within MST-BSF.
The present study involves a rigorous randomized trial of the MST-BSF model, which is now mature after 4 years of implementation. A feasibility review and quasi-experimental evaluation of MST-BSF have been completed prior to this study. MST-BSF acceptability and feasibility are supported by 87% participant recruitment and 93% treatment completion rates. Regarding preliminary outcomes, a matched-comparison study (N = 52) indicated that MST-BSF was more effective than the comprehensive community treatment (CCT) provided in Connecticut at reducing out-of-home placements for the children (13% vs. 39%) and preventing reabuse (CCT families had, on average, four times the number of substantiated reports as MST-BSF families) at 24 months post referral.
In light of these promising results, this hybrid efficacy/effectiveness (real world practitioners, clients, provider organization, and service system; clinical oversight by treatment developers; Fixsen, Naoom, Blasé, Friedman, & Wallace, 2005) study aims to provide a more rigorous and comprehensive evaluation of MST-BSF.
Specifically, the study aims are to:
Aim 1: Determine the effectiveness of MST-BSF relative to CCT for achieving the primary outcomes of reduced parental substance abuse, child maltreatment, and child out-of-home placement.
Hypotheses:
- Parents receiving MST-BSF will exhibit greater reductions in substance abuse and child maltreatment.
Children in the MST-BSF condition will experience fewer incidents of reabuse by all caregivers and receive fewer out-of-home placements than counterparts in the CCT condition.
Aim 2: Determine the effectiveness of MST-BSF relative to CCT for secondary outcomes. For parents, these are variables thought to support abstinence, including reduced psychological distress and symptomatology; increased employment, drug-free activities, and social support; and improved parenting practices. For the child, the key secondary outcome is internalizing symptoms.
Hypotheses:
- Parents receiving MST-BSF will exhibit greater decreases in psychological distress and symptomatology and greater increases in employment, drug-free activities, social support, and positive parenting.
Children receiving MST-BSF will experience fewer internalizing symptoms.
Aim 3: Assuming that outcomes favor MST-BSF for Aims 1-2, examine possible mediators of positive primary outcomes (see Aim 1) from the variables identified as favorable secondary outcomes (see Aim 2).
Hypotheses:
- Decreased parental substance abuse and child maltreatment will be mediated by improved parent psychological distress and symptomatology, employment, drug-free activities, social support, and parenting practices.
Similarly, reduced child out-of-home placements will be mediated by improved parent psychological distress and symptomatology, employment, drug-free activities, social support, and parenting practices.
Aim 4: Assuming favorable outcomes for MST-BSF, evaluate possible moderators of MST-BSF effects.
Hypothesis:
- Consistent with findings from moderator analyses for most other MST-related studies (e.g., Huey & Polo, 2008; Ogden & Hagen, in press), we hypothesize that favorable primary outcomes will not be moderated by participant demographic characteristics (e.g., race, social class, gender of child). Possible clinical level moderators (e.g., parent distress, number of maltreatment referrals at baseline) will be examined.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Britain, Connecticut, United States, 06051
- Connecticut Department of Children and Families
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Parental Substance Abuse
Time Frame: 18 months post baseline
|
18 months post baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Abuse of a child
Time Frame: 18 months post baseline
|
physical abuse and/or neglect
|
18 months post baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Out-of-Home Placement
Time Frame: 18 months post baseline
|
18 months post baseline
|
|
|
Parental Psychological Distress
Time Frame: 18 months post baseline
|
18 months post baseline
|
|
|
Child Internalizing Symptoms
Time Frame: 18 months post baseline
|
Anxiety, Depression, Post-Traumatic Stress Disorder Symptoms
|
18 months post baseline
|
|
Abusive Parenting
Time Frame: 18 months post baseline
|
physical assault, psychological aggression, neglectful parenting
|
18 months post baseline
|
|
Parental Social Support
Time Frame: 18 months post baseline
|
18 months post baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Cynthia C Swenson, Ph.D., Medical University of South Carolina
- Principal Investigator: Cindy M Schaeffer, Ph.D., University of Maryland
Publications and helpful links
General Publications
- Swenson CC, Schaeffer CM, Henggeler SW, Faldowski R, Mayhew AM. Multisystemic Therapy for Child Abuse and Neglect: a randomized effectiveness trial. J Fam Psychol. 2010 Aug;24(4):497-507. doi: 10.1037/a0020324.
- Tuten, M., Jones, H. E., Schaeffer, C. M., Wong, C. J., & Stitzer, M. L. (2012). Reinforcement-based treatment (RBT): A practical guide for the behavioral treatment of drug addiction. Washington, DC: American Psychological Association.
- Swenson, C. C., Schaeffer, C. M., Tuerk, E. H., Henggeler, S. W., Tuten, M. et al. (2009). Adapting multisystemic therapy for co-occurring child maltreatment and parental substance abuse: The Building Stronger Families project. Emotional and Behavioral Disorders in Youth, Winter, 3-8.
- Fixsen, D. L, Naoom, S. F., Blase, K. A., Friedman, R. M., & Wallace, F. (2005). Implementation research: A synthesis of the literature. Tampa, FL: University of South Florida, Louis de la Parte Florida Mental Health Institute, The National Implementation Research Network (FMHI Publication #231).
- Henggeler, S. W., Schoenwald, S. K., Borduin, C. M., Rowland, M. D., & Cunningham, P. B. (2009). Multisystemic therapy for antisocial behavior in children and adolescents (2nd ed.). New York: Guilford Press.
- Kolko, D. J. & Swenson, C. C. (2002). Assessing and treating physically abused children and their families: A cognitive-behavioral approach. Thousand Oaks, CA: Sage Publications.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01DA029726-02 (NIH)
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.
Clinical Trials on Child Abuse
-
Oral Health Centre of Expertise in Western NorwayEducational storytelling forlag og filmCompletedChild Abuse | Oral Health | Child Neglect | Child Maltreatment | Child Sexual Abuse | Dental NeglectNorway
-
Oral Health Centre of Expertise in Western NorwayOral Health Center of Expertise Rogaland, Norway; Childrens advocacy center... and other collaboratorsRecruitingChild Abuse | Child Neglect | Child MaltreatmentNorway
-
Yeditepe UniversityRecruitingEducational Program's Impact on Nursing Students' Knowledge and Awareness of Child Abuse and NeglectChild Abuse | Child NeglectTurkey
-
Karolinska InstitutetCompletedChild Abuse | Child MaltreatmentSweden
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedChild Abuse | Child NeglectUnited States
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
University of PittsburghPatient-Centered Outcomes Research Institute; Northwell Health; University of...CompletedChild Abuse | Trauma | Child Maltreatment | Physical AbuseUnited States
-
Buzzi Children's HospitalNot yet recruitingChild Abuse | Child Neglect | Child Maltreatment
-
University of ChicagoUniversity of California, Los Angeles; Oak Foundation; UBS Optimus Foundation; Women... and other collaboratorsCompletedChild Abuse | Child MaltreatmentBurkina Faso
-
Institute of Psychiatry, LondonBanaras Hindu University; Tribhuvan University, NepalCompletedChild Abuse | Child Neglect | VictimizationIndia, Nepal
Clinical Trials on MST-BSF
-
The Affiliated Hospital of the Chinese Academy...Not yet recruitingAdvanced and Relapsed Solid TumorsChina
-
Mabsoft Therapeutics (Shanghai) Co., Ltd.Mabsoft Therapeutics (Australia) Pty. Ltd.; Mabsoft Therapeutics (Guangdong...Not yet recruiting
-
Centre for Addiction and Mental HealthUniversity of British Columbia; Brain Canada; Ontario Shores Centre for Mental...CompletedBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II DisorderCanada
-
The Hong Kong Polytechnic UniversityPrince of Wales Hospital, Shatin, Hong Kong; Innovation and Technology Commission...RecruitingFoot Drop | Cerebrovascular Stroke | Foot Inversion DeformityChina
-
Boston Children's HospitalNot yet recruiting
-
Centre for Addiction and Mental HealthUniversity of British Columbia; Brain Canada; Ontario Shores Centre for Mental...CompletedDepression | Bipolar Depression | Treatment Resistant Depression | Unipolar DepressionCanada
-
Mestag Therapeutics LimitedRecruiting
-
Centre for Addiction and Mental HealthUniversity of British ColumbiaRecruitingSchizophrenia | Schizoaffective Disorder | Treatment Resistant SchizophreniaCanada
-
De ViersprongRadboud University Medical Center; Koraal; Stichting tot Steun; Prisma; MST-Nethe... and other collaboratorsRecruitingBehavioural ProblemsNetherlands