Substance Abuse Clinical Trial
Official title:
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.
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:
1. Parents receiving MST-BSF will exhibit greater reductions in substance abuse and child
maltreatment.
2. 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:
3. 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.
4. 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:
5. 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.
6. 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:
7. 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04070521 -
EEG Monitoring in the Emergency Department
|
||
Completed |
NCT00729391 -
Women-Focused HIV Prevention in the Western Cape
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT03129334 -
Preventing Prescription Drug Abuse in Middle School Students
|
N/A | |
Completed |
NCT02733003 -
Implementation Research for Vulnerable Women in South Africa
|
N/A | |
Completed |
NCT02573948 -
Feasibility of Interventions on People Who Inject Drugs in Vietnam
|
||
Completed |
NCT02282306 -
Phone Interview to Prevent Recurring Opioid Overdoses
|
N/A | |
Withdrawn |
NCT01847300 -
cSBI-M for Young Military Personnel
|
N/A | |
Withdrawn |
NCT01523444 -
Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings
|
Phase 3 | |
Completed |
NCT01481428 -
Reducing High Risk Behavior in Treatment Court
|
Phase 1 | |
Completed |
NCT01591239 -
Home-Based Program to Help Parents of Drug Abusing Adolescents
|
N/A | |
Completed |
NCT01601743 -
Exercise as a Behavioral Treatment for Cocaine Dependence
|
N/A | |
Active, not recruiting |
NCT00847548 -
Treatment of Intimate Partner Violence and Substance Abuse in a Forensic Setting
|
N/A | |
Withdrawn |
NCT01228890 -
Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)
|
Phase 3 | |
Completed |
NCT01614015 -
Building Outcomes With Observation-Based Supervision: An FFT Effectiveness Trial
|
Phase 2 | |
Completed |
NCT01621334 -
The Men's Domestic Abuse Check-Up Engages Adult Men Concerned About Their Abusive Behavior and Alcohol or Drug Use
|
Phase 1 | |
Completed |
NCT00841711 -
Transitions: Linkages From Jail To Community
|
N/A | |
Completed |
NCT00717444 -
Healthy Activities for Prize Incentives
|
N/A | |
Completed |
NCT00685074 -
Computer-based Brief Intervention for Perinatal Substance Abuse
|
Phase 1/Phase 2 | |
Completed |
NCT01188434 -
Integrating Interventions for Maternal Substance Abuse
|
Phase 1 | |
Completed |
NCT01465490 -
Monitoring and Feedback in Substance Abuse Treatment
|
Phase 1/Phase 2 |