Back to resultsCRAFT Behavior Therapy: Treatment Entry Component
Primary Purpose
Drug Addiction, Stimulant Dependence, Opiate Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Community Reinforcement and Family Training
Treatment Entry Training
12- step Al/Nar- Anon Facilitation
Sponsored by
About this trial
This is an interventional treatment trial for Drug Addiction focused on measuring Family Therapy, Relationship Dysfunction, Family Dysfunction, Family Relations, Stimulant Dependence, Opiate Dependence, Alcohol Dependence, Behavior Therapy, Drug Treatment, Substance Abuse, Drug Addiction
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
Sites / Locations
- TRI South Street
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
ANft
TEnT
CRAFT
Arm Description
12- step Al/Nar-Anon Facilitation
Treatment Entry Training
Community Reinforcement and Family Training
Outcomes
Primary Outcome Measures
Treatment entry of the drug user
Secondary Outcome Measures
Reduction in drug use
Improvements in mood and functioning
Full Information
NCT ID
NCT00842036
First Posted
February 11, 2009
Last Updated
March 27, 2023
Sponsor
Treatment Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00842036
Brief Title
CRAFT Behavior Therapy: Treatment Entry Component
Official Title
CRAFT Behavior Therapy Phase 2 Study: Treatment Entry Component
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Treatment Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ANft
Arm Type
Active Comparator
Arm Description
12- step Al/Nar-Anon Facilitation
Arm Title
TEnT
Arm Type
Experimental
Arm Description
Treatment Entry Training
Arm Title
CRAFT
Arm Type
Experimental
Arm Description
Community Reinforcement and Family Training
Intervention Type
Behavioral
Intervention Name(s)
Community Reinforcement and Family Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment Entry Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
12- step Al/Nar- Anon Facilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment entry of the drug user
Time Frame
This may occur at any point throughout the participants' involvement in the study
Secondary Outcome Measure Information:
Title
Reduction in drug use
Time Frame
2 month, 4 month, 6 month, and 9 month assessments
Title
Improvements in mood and functioning
Time Frame
2 month, 4 month, 6 month, and 9 month assessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly C Kirby, Ph.D.
Organizational Affiliation
Treatment Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
TRI South Street
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
CRAFT Behavior Therapy: Treatment Entry Component
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