CRAFT Behavior Therapy: Treatment Entry Component - Full Text View

Sponsor:	Treatment Research Institute
Information provided by:	Treatment Research Institute
ClinicalTrials.gov Identifier:	NCT00842036

Purpose

This research compares the benefits of the original treatment, Community Reinforcement and Family Training (CRAFT), with the Treatment Entry Training (TEnT) component of CRAFT to determine if TEnt alone can produce the primary outcome of CRAFT -- treatment entry of the drug user. We also look at the impact on the well-being of the concerned significant other and the drug use of their loved one.

Condition	Intervention	Phase
Drug Addiction Stimulant Dependence Opiate Dependence Alcohol Dependence Substance Abuse	Behavioral: Community Reinforcement and Family Training Behavioral: Treatment Entry Training Behavioral: 12- step Al/Nar- Anon Facilitation	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	CRAFT Behavior Therapy Phase 2 Study: Treatment Entry Component

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

U.S. FDA Resources

Further study details as provided by Treatment Research Institute:

Primary Outcome Measures:

Treatment entry of the drug user [ Time Frame: This may occur at any point throughout the participants' involvement in the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in drug use [ Time Frame: 2 month, 4 month, 6 month, and 9 month assessments ] [ Designated as safety issue: No ]
Improvements in mood and functioning [ Time Frame: 2 month, 4 month, 6 month, and 9 month assessments ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	January 2006
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: ANft 12- step Al/Nar-Anon Facilitation	Behavioral: 12- step Al/Nar- Anon Facilitation The underlying philosophy of the 12- step approach for concerned significant others (CSO) is that the CSO is powerless to control the drinker/drug user and must detach, focusing instead on accepting the situation and on strengthening his or her mental health. Eight content areas are discussed with the CSO over the course of the intervention. There will be a minimum of 8 sessions and a maximum of 12 sessions that are each 45-60 minutes long.
Experimental: TEnT Treatment Entry Training	Behavioral: Treatment Entry Training Treatment Entry Training (TEnT) is a component of the Community Reinforcement and Family Training intervention and it is currently under investigation to determine if it is sufficient to produce the primary and most consistent outcome of CRAFT- treatment entry of the drug user. The intervention will consist of a minimum of 4 sessions and a maximum of 6 sessions that are each 45-60 minutes long. TEnT will include awareness training, safety training, and the Treatment Entry Training component of CRAFT.
Experimental: CRAFT Community Reinforcement and Family Training	Behavioral: Community Reinforcement and Family Training Community Reinforcement and Family Training (CRAFT) is an intervention designed for the concerned significant other (CSO) of a drug or alcohol using loved one. The CRAFT intervention consists of approximately 12 sessions lasting 45-60 minutes. The goal of the CRAFT intervention is to train the CSO in new ways to interact with the person of concern (PC). There are four components that the CSO is trained on which include awareness training, community reinforcement training, treatment entry training, and CSO mood enhancement.

Detailed Description:

The consequences of drug abuse are not limited to drug users; they also extend to their families and concerned significant others (CSOs). Research shows that CSOs of drug users have increased prevalence of illness, domestic violence, and problems in mood and functioning. Because CSOs are troubled by the negative effects of drug use on the drug user and themselves, they may be a social community that is particularly invested in learning ways to positively influence the drug user.

We compare the benefits of the original treatment, Community Reinforcement and Family Training (CRAFT), with the Treatment Entry Training (TEnT) component of CRAFT to see if the TEnt is sufficient to produce the primary and most consistent outcome of CRAFT -- treatment entry of the drug user.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Concerned Significant Other (CSO) and Person of Concern (PC) over 18 years of age
is a family member (such as a close relative, spouse, intimate partner), roommate or significant other who is concerned about a PC
reports that the PC has a pattern of drug or alcohol use that meets the criterion for abuse or dependence on stimulants, opiates, or alcohol according to DSM-IV-TR
reports that the PC is not currently in treatment and has not received treatment during the past 6 weeks (other than detoxification)
reports having been in the relationship with the identified PC for at least 3 months
reports contact with the identified PC on at least 12 of the past 30 days with no planned change in the amount of contact in the next 10 months
provides evidence that the PC has refused to seek treatment when CSO asked

Exclusion Criteria:

does not demonstrate complete understanding of their participation by reading the consent form and passing a consent quiz that tests comprehension of the basic elements of informed consent and requirements of the protocol, or does not agree to participate by signing an informed consent
declines to: provide valid locator information, allow videotaped sessions, and/or participate in follow-ups
CSO has a drug abuse problem themselves as determined through clinical assessment and DSM-IV-TR criteria
is not able to comprehend the content in the self-report materials (written at about 6th grade reading level)
reports that the PC behaves in a manner consistent with an unremitting psychosis or another psychiatric disorder (e.g., significant developmental delay) that would contraindicate the planned CRAFT intervention
intends to receive more than 6 hours of individual counseling focusing on the PC's addiction for the 6 months after they are enrolled in the study
PC has a recent history of severe domestic violence (e.g., the PC has committed criminal assault during the past 2 years, or has a history of severe violence involving a weapon or resulting in hospitalization
has an immediate family member, friend, roommate, co-worker, or other person who has already enrolled in the study and his/her participation is not likely to be independent of the initially enrolled CSO's participation
fails to complete 2 sessions with a family trainer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842036

Locations

United States, Pennsylvania
TRI South Street
Philadelphia, Pennsylvania, United States, 19106

Sponsors and Collaborators

Treatment Research Institute

Investigators

Principal Investigator:

Kimberly C Kirby, Ph.D.

Treatment Research Institute

More Information

Additional Information:

Study description for recruitment purposes. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Kimberly C. Kirby, Ph.D., Principal Investigator, Treatment Research Institute
ClinicalTrials.gov Identifier:	NCT00842036 History of Changes
Other Study ID Numbers:	0406, 5R01DA018696
Study First Received:	February 11, 2009
Last Updated:	June 24, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Treatment Research Institute:

Family Therapy
Relationship Dysfunction
Family Dysfunction
Family Relations
Stimulant Dependence
Opiate Dependence

Alcohol Dependence
Behavior Therapy
Drug Treatment
Substance Abuse
Drug Addiction

Additional relevant MeSH terms:

Alcoholism
Substance-Related Disorders
Behavior, Addictive
Opioid-Related Disorders

Alcohol-Related Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior

ClinicalTrials.gov processed this record on February 09, 2012