Internet-based A-CRA for Young Adults With Problematic Alcohol Use (I-A-CRA)

March 29, 2022 updated by: Nitya Jayaram-Lindstrom

Internet-based Adolescent Community Reinforcement Approach (I-A-CRA) With Therapist Support for Young Adults With Problematic Alcohol Use: A Randomized Controlled Trial

The primary aim of the study is to evaluate the feasibility and acceptability of an internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA) with therapist support for young adults (aged 18-24 years) with problematic alcohol use and their caregiver/significant other. Secondary aims include investigating the role of comorbid emotional symptoms, emotion regulation and prosocial behavior in treatment outcomes for the young adults. In a randomized controlled pilot trial, participants (n = 60 young adults as well as an optional accompanying caregiver/significant other) will be recruited from the community through advertisements as well as through clinic referrals in Stockholm, Sweden. Eligible participants will be randomized either to the 10-week I-A-CRA treatment or to an active control group (receiving psychoeducation about alcohol use over the same time frame). In both conditions an optionally accompanying caregiver/significant other will receive a support program in conjunction with the young adult's treatment. Participating young adults will be evaluated with regards to their alcohol use, psychiatric symptoms, emotion regulation, and prosocial behavior at pre-treatment, weekly during treatment, post-treatment, and at a 3-month follow-up. The primary outcome will be feasibility (measured as number of treatment completers; i.e., having completed 5 out of 8 treatment modules), and acceptability (measured by patient satisfaction). Secondary outcomes will include pre- and post-treatment self-rated binge drinking episodes, levels of depression, anxiety and stress, emotion dysregulation, and prosocial behavior. Self-reports regarding stress, emotion dysregulation, and prosocial behavior will be complemented by behavioral measures (computerized tasks).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Maria E AAbonde Garke, M.Sc.
  • Phone Number: +46 70 285 96 14
  • Email: maria.garke@ki.se

Study Contact Backup

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Recruiting
        • eStod, Maria Ungdom, Stockholm Centre for Dependency Disorders
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Young adult between 18-24 years of age
  • Reporting ongoing substance use (alcohol), heavy drinking measured as risky use according to recommendations: 5/4 (male/female) standard drinks on a minimum of two occasions in the last month, or AUDIT-C ≥ 4 points indicating harmful consumption
  • Access to internet via computer or other similar device, as well as access to smartphone
  • If on psychiatric medication, it should have been a stable dosage during the past 3 months prior to pre-treatment assessment
  • Adequate knowledge in the Swedish language and a Swedish personal identification number

Exclusion Criteria:

  • Current DSM-5 diagnosis for any other substance use disorder except nicotine dependence
  • Current (including last 12 months) DSM-5 diagnosis for other major psychiatric disorder (bipolar disorder, psychosis)
  • Recent initiation of psychiatric medication or psychotherapy (within the last 3 months)
  • Suicidal ideation at screening
  • Serious somatic diagnosis requiring medical attention, such as uncontrolled diabetes mellitus, epilepsy or heart conditions
  • Traces of any psychoactive substance (e.g., central stimulant amines, THC, benzodiazepines, opiates, cocaine) in urine sample at baseline assessment
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: I-A-CRA
Internet-delivered Adolescent Community Reinforcement Approach: The treatment program consists of 8 extensive treatment modules delivered over 10 weeks with continuous therapist support and guidance. There are two separate treatments for the young adult and the caregiver/significant other.
Behavioral: Internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA)
The intervention is a behavioral internet-based intervention based on the Adolescent Community Reinforcement Approach. The program encompasses text, pictures, videos, and written as well as practical assignments (skills training). The main components of the treatment for the young adult with problematic alcohol use consist of psychoeducation and functional analysis, goal formulation, increasing prosocial behaviors, relapse prevention, problem solving, and communication training. The accompanying significant other receives modules containing information focusing on gaining an understanding of the treatment components aimed at the young adult, as well as communication training to improve communication between the young adult and the significant other.
Active Comparator: Psychoeducation alcohol use
Psychoeducation focusing on alcohol use: This support program provides 8 brief modules of psychoeducation (alcohol information) over 10 weeks. Participants receive no therapist guidance/support but have the possibility of asking questions to a therapist. There are two separate programs for the young adult and the caregiver/significant other.
Behavioral: Psychoeducation, information on use of alcohol and its effects
The intervention is a behavioural internet-based intervention including psychoeducation focusing on providing information on alcohol, alcohol use, and its effects. The psychoeducation is provided via texts and pictures, and there is a possibility of asking questions to a therapist if needed however no therapist contact is mandatory. There are separate programs directed towards the young adult and the accompanying significant other. The programmes give brief self-help tips at the end. The intervention approximately corresponds to the information given in a primary care setting for someone with problematic alcohol use.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of treatment completers defined as patients completing 5 or more of the 8 modules of treatment
Time Frame: Will be assessed post treatment (11 weeks after treatment initiation)
Outcome used to assess feasibility.
Will be assessed post treatment (11 weeks after treatment initiation)
Client Satisfaction Questionnaire 8 item
Time Frame: Will be assessed post treatment (11 weeks after treatment initiation)
Acceptance will be measured as percentage of participants rating their satisfaction as good. Higher score indicates better outcome. Scores range from 8-32.
Will be assessed post treatment (11 weeks after treatment initiation)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Timeline Follow-back - change in time spent doing activities unrelated to drinking
Time Frame: Will be assessed before treatment initiation, at week 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of treatment, and post treatment (11 weeks after treatment initiation)
Number of self-reported activities registered that are not related to alcohol consumption over the past week. More episodes is a better outcome.
Will be assessed before treatment initiation, at week 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of treatment, and post treatment (11 weeks after treatment initiation)
Alcohol Use Disorders Identification Test - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Self-reported screening of alcohol use disorder symptoms. Higher scores indicate worse outcome. Scores range from 0-40.
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Difficulties in Emotion Regulation Scale 16 item - change over timepoints
Time Frame: Will be assessed before treatment initiation, at week 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of treatment, and post treatment (11 weeks after treatment initiation)
Self-report scale measuring emotion dysregulation. Higher scores indicate worse outcome. Scores range from 16-80.
Will be assessed before treatment initiation, at week 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of treatment, and post treatment (11 weeks after treatment initiation)
Depression Anxiety Stress Scale-21 - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Self-report scale measuring symptoms of depression, anxiety and stress over the past week. Higher scores indicates worse outcome. Scores range from 0-42.
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Timeline Follow-back - change in self-rated alcohol consumption
Time Frame: Will be assessed before treatment initiation, at week 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of treatment, and post treatment (11 weeks after treatment initiation)
Number of heavy drinking episodes (heavy drinking defined as 4 or more drinks per drinking occasion in women and 5 or more for men) over the past week. Fewer episodes is a better outcome.
Will be assessed before treatment initiation, at week 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of treatment, and post treatment (11 weeks after treatment initiation)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Barratt Impulsiveness Scale - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Self-report scale measuring behavioral impulsivity. Higher scores indicates worse outcome. Scores range from 30-120.
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Adult ADHD Self-Report Screener - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Self-report scale measuring ADHD symptoms. Higher score indicates worse outcome.
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Obsessive Compulsive Drinking Scale - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Self-report scale measuring compulsive drinking.
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Pro-social behavior - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Computerized experimental behavior tasks measuring reward-based pro-social behavior and decision making regarding generous, trustful, reciprocal and compensatory behavior.
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Emotion regulation/distress tolerance (Paced Auditory Serial Addition Task) - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Computerized behavior task measuring emotion regulation/distress tolerance. A longer time spent doing the task indicates better outcome.
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Drinking Motive Questionnaire Revised Short Form - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Self-report scale measuring drinking motives.
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Drug Use Disorders Identification Test - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Self-report screening of any drug use disorder symptoms. Higher score indicates worse outcome. Scores range from 0-44.
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Social Interaction Anxiety Scale - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Self-report scale measuring symptoms of social anxiety.
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Prosocial Tendencies Measure - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Self-report scale measuring prosocial behavior.
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Oxford Utilitarianism Scale - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Self-report scale measuring prosocial behavior.
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Questionnaire of Cognitive and Affective Empathy - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Self-report scale measuring prosocial behavior (empathy).
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Positive Personality Traits - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Self-report scale measuring prosocial behavior (positive personality traits).
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Social Value Orientation - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Self-report scale measuring prosocial behavior.
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Autism Spectrum Quotient Short Form - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Self-report scale measuring symptoms of autism spectrum disorder. Higher scores indicate worse outcome.
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Positive and Negative Affect Schedule - Negative affect - change pre to post treatment
Time Frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Self-report scale measuring negative affect in the moment on a 5-point scale (higher score indicates more negative affect).
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
VAS Single Item Craving Question - change over timepoints
Time Frame: Will be assessed before treatment initiation, at week 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of treatment, and post treatment (11 weeks after treatment initiation)
Self-report scale measuring craving for alcohol in the moment on a visual analog scale ranging from 0-100 (a higher score indicates more craving).
Will be assessed before treatment initiation, at week 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of treatment, and post treatment (11 weeks after treatment initiation)
Significant other, change in rating of drinking in the young adult (with Timeline Follow-back)
Time Frame: Will be assessed at week 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of treatment
Self-report scale measuring alcohol use in the young adult as assessed by significant other in the past week. Higher number of episodes indicates worse outcome.
Will be assessed at week 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of treatment
Socioeconomic and Demographic Questionnaire
Time Frame: Will be assessed before treatment initiation
Self-report of demographic information.
Will be assessed before treatment initiation
EQ-5D
Time Frame: Will be assessed before treatment initiation
Self-report scale measuring disability (a higher score indicates worse outcome) and generic health status (rated on a visual analog scale ranging from 0-100 where higher score indicates better outcome).
Will be assessed before treatment initiation
Family Tree Questionnaire
Time Frame: Will be assessed before treatment initiation
Self-report scale assessing family history of alcohol problems, number of family history-positive and family history-negative relatives.
Will be assessed before treatment initiation
Negative Effects Questionnaire
Time Frame: Will be assessed post treatment (11 weeks after treatment initiation)
Self-report scale measuring negative effects associated with psychotherapy. Higher score indicates worse outcome.
Will be assessed post treatment (11 weeks after treatment initiation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nitya Jayaram-Lindstrom

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nitya Jayaram-Lindstrom, Ph.D., Department of Clinical Neuroscience, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018/1264-31/5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD will be shared in accordance with institutional guidelines at the Karolinska Institutet, Stockholm, Sweden.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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