NCT00842036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

3.9 years

First QC Date

February 11, 2009

Last Update Submit

March 27, 2023

Conditions

Keywords

Family TherapyRelationship DysfunctionFamily DysfunctionFamily RelationsStimulant DependenceOpiate DependenceAlcohol DependenceBehavior TherapyDrug TreatmentSubstance AbuseDrug Addiction

Outcome Measures

Primary Outcomes (1)

  • Treatment entry of the drug user

    This may occur at any point throughout the participants' involvement in the study

Secondary Outcomes (2)

  • Reduction in drug use

    2 month, 4 month, 6 month, and 9 month assessments

  • Improvements in mood and functioning

    2 month, 4 month, 6 month, and 9 month assessments

Study Arms (3)

ANft

ACTIVE COMPARATOR

12- step Al/Nar-Anon Facilitation

Behavioral: 12- step Al/Nar- Anon Facilitation

TEnT

EXPERIMENTAL

Treatment Entry Training

Behavioral: Treatment Entry Training

CRAFT

EXPERIMENTAL

Community Reinforcement and Family Training

Behavioral: Community Reinforcement and Family Training

Interventions

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.

CRAFT

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.

TEnT

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.

ANft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TRI South Street

Philadelphia, Pennsylvania, 19106, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersOpioid-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNarcotic-Related DisordersAlcohol-Related Disorders

Study Officials

  • Kimberly C Kirby, Ph.D.

    Treatment Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2009

First Posted

February 12, 2009

Study Start

January 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations