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Secondary Effects of Parent Treatment for Drug Abuse on Children

Primary Purpose

Behavioral Couples Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Behavioral Couples Therapy
Sponsored by
Old Dominion University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Behavioral Couples Therapy focused on measuring Cognitive Behavioral Therapy, Couples Treatment, Alcohol Use, Effects on Youth

Eligibility Criteria

6 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Lifestyle Counseling

    Arm Description

    Couples receive behavioral couples therapy for parental drug use.

    Outcomes

    Primary Outcome Measures

    Effects of Parents' SA Treatment on Youth Behavioral,Emotional and SA Outcomes of Drug Use of Parents
    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
    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.

    Full Information

    First Posted
    June 23, 2010
    Last Updated
    March 29, 2016
    Sponsor
    Old Dominion University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01172587
    Brief Title
    Secondary Effects of Parent Treatment for Drug Abuse on Children
    Official Title
    Secondary Effects of Parent Treatment for Drug Abuse on Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2009 (undefined)
    Primary Completion Date
    April 2016 (Anticipated)
    Study Completion Date
    June 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Old Dominion University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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 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 BCT 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 BCT 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 study is the next important step for this line of research. First, the present study is a far more developed examination of the potential effects of BCT on multiple dimensions of youth functioning, taken from multiple perspectives. Second, we do not know "how" BCT works. The positive effects of BCT 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 BCT 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 BCT 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 BCT to meet the needs of families with children of different ages. To address these issues, the present study will examine how BCT is associated with changes in the emotional and behavioral adjustment, beliefs, and behaviors, including serious problem behaviors, of youth ages 5 to 18 (as rated by mothers, fathers, and the children themselves). We will also focus on potential mechanisms of action that are positively influenced by BCT.
    Detailed Description
    The present study 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 BCT on multiple dimensions of youth functioning, taken from multiple perspectives. Second, we do not know "how" BCT works. The positive effects of BCT 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 BCT 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 BCT 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 BCT to meet the needs of families with children of different ages. To address these issues, the present study will compare the emotional and behavioral adjustment, beliefs, and behaviors, including serious problem behaviors, of youth ages 5 to 18 (as rated by mothers, fathers, and the children themselves) whose mothers or fathers take part in BCT to an Intent-to-Treat group. We will focus on potential mechanisms of action that are positively influenced by BCT. We intend to use the information collected from the proposed investigation to refine and modify BCT 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 BCT, resulting in empirically informed BCT 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 BCT refinement and interventions for couples entering BCT who have custodial children, the latter of whom we may only be able to help by helping their parents.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Behavioral Couples Therapy
    Keywords
    Cognitive Behavioral Therapy, Couples Treatment, Alcohol Use, Effects on Youth

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    366 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lifestyle Counseling
    Arm Type
    Experimental
    Arm Description
    Couples receive behavioral couples therapy for parental drug use.
    Intervention Type
    Other
    Intervention Name(s)
    Behavioral Couples Therapy
    Intervention Description
    Couples participate in 12 sessions of Behavioral Couples Therapy designed to reduce substance use and increase relationship functioning.
    Primary Outcome Measure Information:
    Title
    Effects of Parents' SA Treatment on Youth Behavioral,Emotional and SA Outcomes of Drug Use of Parents
    Description
    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.
    Time Frame
    up to six months post-treatment
    Secondary Outcome Measure Information:
    Title
    Effectiveness of Behavioral Couples Treatment for Drug Use
    Description
    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.
    Time Frame
    up to six months post-treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michelle L Kelley, Ph.D.
    Organizational Affiliation
    Old Dominion University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    Kelley, M. L., Klostermann, K., & Henson, J. M. (2013). Cognitive-behavioral couples therapy for substance abusing parents. In N. Suchman, M. Pajulo, & L. Mayes (Eds.), Parenting and Substance Addiction: Developmental Approaches to Intervention. Cambridge: Oxford University Press.
    Results Reference
    background
    PubMed Identifier
    21707469
    Citation
    Klostermann K, Kelley ML, Mignone T, Pusateri L, Wills K. Behavioral couples therapy for substance abusers: where do we go from here? Subst Use Misuse. 2011;46(12):1502-9. doi: 10.3109/10826084.2011.576447. Epub 2011 Jun 28.
    Results Reference
    background
    PubMed Identifier
    24680218
    Citation
    Kelley ML, D'Lima GM, Henson JM, Cotten C. Substance-abusing mothers and fathers' willingness to allow their children to receive mental health treatment. J Subst Abuse Treat. 2014 Jul;47(1):106-11. doi: 10.1016/j.jsat.2014.02.007. Epub 2014 Mar 6.
    Results Reference
    background
    PubMed Identifier
    25724658
    Citation
    Kelley ML, Lawrence HR, Milletich RJ, Hollis BF, Henson JM. Modeling risk for child abuse and harsh parenting in families with depressed and substance-abusing parents. Child Abuse Negl. 2015 May;43:42-52. doi: 10.1016/j.chiabu.2015.01.017. Epub 2015 Feb 25.
    Results Reference
    background
    Citation
    Kelley, M. L., Hollis, B. F., Milletich, R. J., Henson, J. M., Cooke, C. G., & Kurtz, E. D. (2015). Childcare involvement, satisfaction with one's partner as a parent, and dyadic satisfaction among fathers with substance use disorders and their nonsubstance-abusing partners. Fathering,13(2).
    Results Reference
    background
    Citation
    Kelley, M. L., White, T. D., Milletich, R. J., Hollis, B. F., Haislip, B. N., Heidt, C., & Henson, J. M, (in press). Youth emotional reactivity to interparental conflict and parental hostility as related to worrying among children living with substance-abusing parents. Journal of Child and Family Studies.
    Results Reference
    background
    PubMed Identifier
    26742725
    Citation
    Kelley ML, Bravo AJ, Braitman AL, Lawless AK, Lawrence HR. Behavioral Couples Treatment for Substance Use Disorder: Secondary Effects on the Reduction of Risk for Child Abuse. J Subst Abuse Treat. 2016 Mar;62:10-9. doi: 10.1016/j.jsat.2015.11.008. Epub 2015 Dec 2.
    Results Reference
    background
    Citation
    Kelley, M. L., & Braitman, A. L. (2016). Antisocial behavior and intimate partner violence among single and dual substance-abusing couples. Journal of Family Violence. Jan. 21st, 2016.
    Results Reference
    background
    PubMed Identifier
    27064819
    Citation
    Braitman AL, Kelley ML. Initiation and retention in couples outpatient treatment for parents with drug and alcohol use disorders. Exp Clin Psychopharmacol. 2016 Jun;24(3):174-184. doi: 10.1037/pha0000072. Epub 2016 Apr 11. Erratum In: Exp Clin Psychopharmacol. 2018 Jun;26(3):327-328.
    Results Reference
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