Trial record 3 of 362 for:    "drug abuse" | Open Studies

Secondary Effects of Parent Treatment for Drug Abuse on Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Old Dominion University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Michelle L. Kelley, Old Dominion University
ClinicalTrials.gov Identifier:
NCT01172587
First received: June 23, 2010
Last updated: April 6, 2012
Last verified: April 2012
  Purpose

As they move from preadolescence to adolescence and adulthood, children need nurturing and supportive environments to realize their potential. Unfortunately, many children reside in destructive families that often result in negative short and long-term outcomes. As well-chronicled in the scientific and lay press, an all-too-common example involves parental substance abuse. Indeed, children living with a parent who abuses substances often have significant emotional, behavioral, and social problems. It has long been recognized that interventions are needed to address the clinical needs of these youth and to help prevent the development of problems that may emerge in early adulthood. To date, the majority of treatments have focused on either treating the children individually, or in the context of family therapy. Although directly involving these youth in treatment may be ideal, the majority of custodial parents who enter treatment for substance abuse are very reluctant to allow their children to engage in individual or family therapy. Thus, interventions for substance-abusing parents that do not directly involve children, but serve to improve the family environment as a whole, may have the greatest potential for reaching the most children and thereby positively influencing their overall adjustment and well-being.

From this vantage, a promising approach is Learning Sobriety Together (LST; the "brand" name of Behavioral Couples Therapy [BCT] for alcoholism and drug abuse), a comprehensive psychosocial intervention for substance abuse that focuses both on reducing addiction severity, improving couple adjustment, reducing interparental conflict and intimate partner violence (IPV), and improving the family environment and psychological functioning. In a series of preliminary studies, the PI found that children whose substance-abusing fathers and nonsubstance-abusing mothers participated in LST displayed higher psychosocial adjustment at posttreatment and during an extended follow-up than youth whose substance-abusing fathers participated in individual-based treatment (IBT) or whose parents participated in a couples-based attention control treatment. These findings indicate that LST may extend beyond the couple to their children and may provide an entry point into the family system from which to improve the adjustment of these youth.

The present randomized clinical trial provides the next important step for this line of research. First, the present study is a far more developed examination of the potential effects of LST on multiple dimensions of youth functioning, taken from multiple perspectives. Second, we do not know "how" LST works. The positive effects of LST on parents (reduced addition severity, improved dyadic adjustment, reduced partner violence, improved parenting, and improved parental psychological adjustment) may have positive "trickle down" effects on youth; however, we have not undertaken an empirical examination of these potential mechanisms of action. If we can understand how it works, we will be able to use that information to refine LST to enhance the mechanisms that benefit youth. Thus, the present study will examine possible curative mechanisms. Third, we have a very limited understanding for "whom" it works. Thus, we will examine whether LST may operate differently for children of different stages of development. If we can understand this moderating effect, we may be able to develop and refine LST to meet the needs of families with children of different ages.

To address these issues, the present study is a randomized clinical trial (RCT) to compare the emotional and behavioral adjustment, beliefs, and behaviors, including serious problem behaviors, of youth ages 6 to 18 (as rated by mothers, fathers, teachers, and the children themselves) whose mothers or fathers are randomly assigned to participate in LST with their nondrug using partners as compared to parents who are assigned to IBT. We will also focus on potential mechanisms of action that are positively influenced by LST.


Condition Intervention
Behavioral Couples Therapy
Behavioral: Individual Substance Abuse Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Secondary Effects of Parent Treatment for Drug Abuse on Children

Further study details as provided by Old Dominion University:

Primary Outcome Measures:
  • Effects of Parents' SA Treatment on Youth Behavioral,Emotional and SA Outcomes of Drug Use of Parents [ Time Frame: up to six months post-treatment ] [ Designated as safety issue: No ]
    A sample of 160 heterosexual couples with children will be recruited. All male or female partners will meet DSM-IV current criteria for alcohol or drug dependence. All couples will complete measures that assess their substance use, dyadic satisfaction, IPV, parenting, potential for child abuse, CPS involvement, and psychological functioning. Children will complete measures that depression symptoms, anxiety, externalizing symptoms, exposure to violence, emotional security, substance use, and perceptions of their parents' parenting behavior.


Secondary Outcome Measures:
  • Effectiveness of Behavioral Couples Treatment for Drug Use [ Time Frame: up to six months post-treatment ] [ Designated as safety issue: No ]
    A sample of 160 heterosexual couples with children will be recruited. All male partners will meet DSM-IV current criteria for alcohol or drug dependence. All couples will complete measures that assess their substance use, dyadic satisfaction, IPV, parenting, potential for child abuse, CPS involvement, and psychological functioning. Children will complete measures that depression symptoms, anxiety, externalizing symptoms, exposure to violence, emotional security, substance use, and perceptions of their parents' parenting behavior.


Estimated Enrollment: 480
Study Start Date: July 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle Counseling
Couples receive behavioral couples therapy for parental drug use.
Behavioral: Individual Substance Abuse Treatment
Fathers or mothers participate in individual substance abuse treatment.
Active Comparator: Individual Drug Abuse Treatment
Mothers or fathers participate in individual substance abuse treatment.
Behavioral: Individual Substance Abuse Treatment
Fathers or mothers participate in individual substance abuse treatment.

Detailed Description:

The present randomized clinical trial provides the next important step for this line of research. First, the present study is a far more developed examination of the potential effects of LST on multiple dimensions of youth functioning, taken from multiple perspectives. Second, we do not know "how" LST works. The positive effects of LST on parents (reduced addition severity, improved dyadic adjustment, reduced partner violence, improved parenting, and improved parental psychological adjustment) may have positive "trickle down" effects on youth; however, we have not undertaken an empirical examination of these potential mechanisms of action. If we can understand how it works, we will be able to use that information to refine LST to enhance the mechanisms that benefit youth. Thus, the present study will examine possible curative mechanisms. Third, we have a very limited understanding for "whom" it works. Thus, we will examine whether LST may operate differently for children of different stages of development. If we can understand this moderating effect, we may be able to develop and refine LST to meet the needs of families with children of different ages.

To address these issues, the present study is a randomized clinical trial (RCT) to compare the emotional and behavioral adjustment, beliefs, and behaviors, including serious problem behaviors, of youth ages 6 to 18 (as rated by mothers, fathers, teachers, and the children themselves) whose mothers or fathers are randomly assigned to participate in LST with their nonsubstance-abusing partners as compared to parents who are assigned to IBT. We will also focus on potential mechanisms of action that are positively influenced by LST.

We intend to use the information collected from the proposed investigation to refine and modify LST to enhance its positive effects on children. This process of (a) examining multiple dimensions of functioning and (b) evaluating theoretically and empirically identified mediators and moderators to inform intervention development and refinement has been used successfully for over a decade with LST, resulting in empirically informed LST variants for alcoholic patients, drug-abusing patients, patients who engage in domestic violence, female substance-abusing patients, and so on. Thus, this project provides the next critical step for LST refinement and interventions for couples entering LST who have custodial children, the latter of whom we may only be able to help by helping their parents.

  Eligibility

Ages Eligible for Study:   6 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • couples must be married or cohabiting in a stable relationship for at least 2 years
  • both partners must be at least 18 years of age
  • men must be residing in the home for the last 2 years
  • women or men must meet DSM-IV criteria for current alcohol or drug dependence (DSM-IV 4th ed., American Psychiatric Association, 1994)
  • women or men must have medical clearance to engage in abstinence-oriented outpatient treatment
  • women or men must agree to refrain from the use of alcohol or illicit drugs for the duration of treatment
  • women or men must refrain from seeking additional substance abuse treatment except for self-help meetings (e.g., Narcotics Anonymous) for the duration of treatment unless recommended by his primary individual therapist.
  • the randomly selected target child cannot have cognitive or physical limitations that would preclude interview (e.g., mental retardation, blindness).
  • children in the study must be fluent in English.

Exclusion Criteria:

  • if either partner has perpetrated severe levels of violence against the other as assessed by the Timeline Followback Spousal Violence or CTS-2
  • if either parent meets DSM-IV criteria for an organic mental disorder, schizophrenia, delusional (paranoid) disorder, or other psychotic disorders
  • if either partner participates in other substance abuse treatment (except for self-help groups)
  • one or both partners are fearful of participating in couples treatment
  • one or both partners want to leave the relationship, in whole or in part, due to IPV
  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: NCT01172587

Locations
United States, New York
Northpointe Council, Inc. Recruiting
Niagara Falls, New York, United States, 14301
Contact: Daniel Shubsda    716-282-1228    dshubsda@northpointecouncil.org   
Contact: Karen Friedhof    716-282-1228    kfriedhof@northpointecouncil.org   
Principal Investigator: Michelle L Kelley, Ph.D.         
Horizon Health Services Recruiting
Tonawanda, New York, United States, 14150
Contact: Herbert Weis    716-831-1800    hweis@horizon-health.org   
Principal Investigator: Michelle L Kelley, Ph.D.         
Sponsors and Collaborators
Old Dominion University
Investigators
Principal Investigator: Michelle L Kelley, Ph.D. Old Dominion University
  More Information

No publications provided

Responsible Party: Michelle L. Kelley, Professor of Psychology, Old Dominion University
ClinicalTrials.gov Identifier: NCT01172587     History of Changes
Other Study ID Numbers: 1R01DA024740-01A2
Study First Received: June 23, 2010
Last Updated: April 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Old Dominion University:
Cognitive Behavioral Therapy
Couples Treatment
Alcohol Use
Effects on Youth

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

ClinicalTrials.gov processed this record on August 28, 2014