Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Promoting Self-Change From Alcohol Problems: Mechanisms of Change in a Community-Based Intervention (PSC3)

This study has been completed.
Sponsor:
Information provided by:
Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT00732095
First received: August 7, 2008
Last updated: December 13, 2010
Last verified: December 2010
  Purpose

Research has found that natural recovery (self-change) is a very common pathway to change for individuals with alcohol problems, accounting for nearly 75% of recoveries in several national surveys.

Although few members of the public are aware that self-change is possible, it also is the case that many individuals with alcohol problems do not enter treatment because of the stigma or fear of being labeled. The proposed study is based on findings from a recent randomized controlled trial designed to promote self-change in the community for problem drinkers who had never been in treatment. Media advertisements were used to recruit 825 participants. Eligible respondents were sent assessment materials to complete. After the assessment materials were returned, participants were randomly assigned to receive two alcohol pamphlets that were freely available in the community or personalized feedback based on their assessment responses (e.g., how their drinking compared to national norms, health risks associated with their drinking). A 1-year follow up found that while there were no differences in drinking behavior between the groups, both groups had very substantial reductions in their drinking 1-year pre- to 1-year post-intervention. In an attempt to determine what accounted for the change, participants' reports of their drinking were evaluated with regard to critical study elements (e. g., when assessment materials were received). Surprisingly, results revealed that many changed after seeing the advertisement, and before receiving the assessment materials to complete. This suggests that either seeing the ad ("Thinking about changing your drinking?") or a message in the ad ("Did you know that 75% of people change their drinking on their own?") may have catalyzed the change. To evaluate when change occurs and the mechanisms that may give rise to change, a randomized controlled trial involving 3 groups will be conducted. The groups will differ in whether they receive a message informing them that self-change is a common phenomenon (two groups will receive the message, one will not) and the occasion when the message is delivered (consenting to the study and before the assessment vs. with the intervention material). Comparisons made possible by the experimental design will allow an evaluation of the message as a precipitant of change. The use of Timeline Followback retrospective reports of daily drinking and recording of critical dates will allow statistical analysis of patterns of inflection (i.e., change in drinking) related to seeing the ad, receiving the message, receiving and completing the assessment materials, and receiving the intervention materials. Possible explanations for how the message could function as a mechanism of behavior change are offered (e.g., catastrophe theory, cognitive social learning theory). The ultimate objective of this research is to develop cost-effective, large scale interventions that can be viewed as an early stage in a public health, stepped care model by encouraging self-change for individuals with alcohol problems.


Condition Intervention Phase
Alcohol Drinking
Alcohol Abuse
Behavioral: Promoting Self-Change with Ads
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Promoting Self-Change From Alcohol Problems: Mechanisms of Change in a Community-Based Intervention

Resource links provided by NLM:


Further study details as provided by Nova Southeastern University:

Primary Outcome Measures:
  • reduced alcohol use [ Time Frame: 3 months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reduced alcohol related consequences [ Time Frame: 3 months post intervention ] [ Designated as safety issue: No ]

Enrollment: 283
Study Start Date: March 2008
Study Completion Date: August 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Immediate Ad
Behavioral: Promoting Self-Change with Ads
Use of Ads immediate or delayed or no ad

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 21 years of age or older (legal drinking age in US)
  • report drinking an average of >12 drinks per week or having consumed ≥ 5 drinks on ≥ 5 days in the past year
  • sign an informed consent
  • willing to participate in a 90-day follow-up interview by mail after the intervention
  • willing to provide the name, address and phone number of a relative or friend who has known the participant and is willing to be provide information in the form of a short questionnaire about the participant's alcohol use and functioning 90 days after the intervention starts

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732095

Locations
United States, Florida
Nova Southeastern University, Center for Psychological Studies
Ft. Lauderdale, Florida, United States, 33314
Sponsors and Collaborators
Nova Southeastern University
Investigators
Principal Investigator: Linda C Sobell, Ph.D. Nova Southeastern University
  More Information

Publications:
Responsible Party: Nova SEU University, Dr. Linda C.S
ClinicalTrials.gov Identifier: NCT00732095     History of Changes
Other Study ID Numbers: 1R21AA017136, 1R21AA017136
Study First Received: August 7, 2008
Last Updated: December 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Nova Southeastern University:
Self-change
Natural recovery
Alcohol Drinking
Mechanisms of Change
Advertisements

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior

ClinicalTrials.gov processed this record on November 27, 2014