An interventional study of Internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA) and Psychoeducation, information on use of alcohol and its effects in Alcohol Abuse, Binge Drinking and Alcohol Use Disorder, sponsored by Nitya Jayaram-Lindstrom. Status unknown at 1 site in Sweden. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Nitya Jayaram-Lindstrom · Not applicable, Interventional, and Treatment
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).
1,634 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's planned enrollment of 60 is below the median of 88 across 1,395 interventional studies indexed under Alcoholism.
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Exclusion Criteria:
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)
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 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.
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.
Percentage of treatment completers defined as patients completing 5 or more of the 8 modules of treatment
Outcome used to assess feasibility.
Time frame: Will be assessed post treatment (11 weeks after treatment initiation)
Client Satisfaction Questionnaire 8 item
Acceptance will be measured as percentage of participants rating their satisfaction as good. Higher score indicates better outcome. Scores range from 8-32.
Time frame: Will be assessed post treatment (11 weeks after treatment initiation)
Timeline Follow-back - change in time spent doing activities unrelated to drinking
Number of self-reported activities registered that are not related to alcohol consumption over the past week. More episodes is a better outcome.
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)
Alcohol Use Disorders Identification Test - change pre to post treatment
Self-reported screening of alcohol use disorder symptoms. Higher scores indicate worse outcome. Scores range from 0-40.
Time frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Difficulties in Emotion Regulation Scale 16 item - change over timepoints
Self-report scale measuring emotion dysregulation. Higher scores indicate worse outcome. Scores range from 16-80.
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)
Depression Anxiety Stress Scale-21 - change pre to post treatment
Self-report scale measuring symptoms of depression, anxiety and stress over the past week. Higher scores indicates worse outcome. Scores range from 0-42.
Time frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Timeline Follow-back - change in self-rated alcohol consumption
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.
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)
Barratt Impulsiveness Scale - change pre to post treatment
Self-report scale measuring behavioral impulsivity. Higher scores indicates worse outcome. Scores range from 30-120.
Time frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Adult ADHD Self-Report Screener - change pre to post treatment
Self-report scale measuring ADHD symptoms. Higher score indicates worse outcome.
Time frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Obsessive Compulsive Drinking Scale - change pre to post treatment
Self-report scale measuring compulsive drinking.
Time frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Pro-social behavior - change pre to post treatment
Computerized experimental behavior tasks measuring reward-based pro-social behavior and decision making regarding generous, trustful, reciprocal and compensatory behavior.
Time frame: 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
Computerized behavior task measuring emotion regulation/distress tolerance. A longer time spent doing the task indicates better outcome.
Time frame: 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
Self-report scale measuring drinking motives.
Time frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Drug Use Disorders Identification Test - change pre to post treatment
Self-report screening of any drug use disorder symptoms. Higher score indicates worse outcome. Scores range from 0-44.
Time frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Social Interaction Anxiety Scale - change pre to post treatment
Self-report scale measuring symptoms of social anxiety.
Time frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Prosocial Tendencies Measure - change pre to post treatment
Self-report scale measuring prosocial behavior.
Time frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Oxford Utilitarianism Scale - change pre to post treatment
Self-report scale measuring prosocial behavior.
Time frame: 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
Self-report scale measuring prosocial behavior (empathy).
Time frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Positive Personality Traits - change pre to post treatment
Self-report scale measuring prosocial behavior (positive personality traits).
Time frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Social Value Orientation - change pre to post treatment
Self-report scale measuring prosocial behavior.
Time frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Autism Spectrum Quotient Short Form - change pre to post treatment
Self-report scale measuring symptoms of autism spectrum disorder. Higher scores indicate worse outcome.
Time frame: 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
Self-report scale measuring negative affect in the moment on a 5-point scale (higher score indicates more negative affect).
Time frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
VAS Single Item Craving Question - change over timepoints
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).
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)
Significant other, change in rating of drinking in the young adult (with Timeline Follow-back)
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.
Time frame: Will be assessed at week 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of treatment
Socioeconomic and Demographic Questionnaire
Self-report of demographic information.
Time frame: Will be assessed before treatment initiation
EQ-5D
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).
Time frame: Will be assessed before treatment initiation
Family Tree Questionnaire
Self-report scale assessing family history of alcohol problems, number of family history-positive and family history-negative relatives.
Time frame: Will be assessed before treatment initiation
Negative Effects Questionnaire
Self-report scale measuring negative effects associated with psychotherapy. Higher score indicates worse outcome.
Time frame: Will be assessed post treatment (11 weeks after treatment initiation)
Plan to share: Yes — IPD will be shared in accordance with institutional guidelines at the Karolinska Institutet, Stockholm, Sweden.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
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