Clinical trial NCT00842036: CRAFT Behavior Therapy: Treatment Entry Component
Official title: CRAFT Behavior Therapy Phase 2 Study: Treatment Entry Component
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Drug Addiction
Stimulant Dependence
Opiate Dependence
Alcohol Dependence
Substance Abuse
Keywords: Family Therapy
Relationship Dysfunction
Family Dysfunction
Family Relations
Stimulant Dependence
Opiate Dependence
Alcohol Dependence
Behavior Therapy
Drug Treatment
Substance Abuse
Drug Addiction
Lead sponsor: Public Health Management Corporation
Sponsor class: OTHER
First posted: 2009-02-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Treatment entry of the drug user
timeFrame: This may occur at any point throughout the participants' involvement in the study
Secondary outcomes:
measure: Reduction in drug use
timeFrame: 2 month, 4 month, 6 month, and 9 month assessments
measure: Improvements in mood and functioning
timeFrame: 2 month, 4 month, 6 month, and 9 month assessments
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: TRI South Street
state: Pennsylvania
Study officials:
affiliation: Treatment Research Institute
name: Kimberly C Kirby, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: