Back to results3M Study - Maria Malmö Mobile Telephone Study
Primary Purpose
Substance Use Disorders
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Interactive voice response with personal feedback
Interactive voice response without personal feedback
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorders focused on measuring Substance use disorders, Adolescents, Retention, Mobile telephone, Follow-up, Interactive voice response
Eligibility Criteria
Inclusion Criteria:
- Patient applying for substance use disorder treatment at out-patient facility Maria Malmö, Malmö, Sweden, who are less than 25 years old and who provide written informed consent to participate in the study.
Exclusion Criteria:
- Patients who do not provide written informed consent to the study, or whose psychiatric condition or language difficulties make it impossible for them to understand patient information and give informed consent to the study.
Sites / Locations
- Maria Malmö, Dept of Psychiatry Skane and City of Malmö, Sweden
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interactive voice response with personal feedback
Interactive voice response without personal feedback
Arm Description
Interactive voice response follows the client twice weekly for 3 months with respect to symptoms and substance use, in both arms. This intervention group also receives a personalized and automated feedback describing whether the symptom status of the patient is better, worse or equal, compared to the preceding follow-up.
This control group is also followed with identical interactive voice response follow-up, addressing symptoms and substance use, but without the personal feedback.
Outcomes
Primary Outcome Measures
Retention in substance use disorder treatment
Duration of retention in treatment and whether the client remains in treatment at 3 months or not.
Secondary Outcome Measures
Improvement in substance use
Do patients in the intervention group improve more than in the control group, with respect to substance use (alcohol/drug use), during the duration of the interactive voice response intervention?
Improvements in psychiatric symptoms
Do patients in the intervention group improve more than in the control group, with respect to psychiatric symptoms, during the duration of the interactive voice response intervention?
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01706380
Brief Title
3M Study - Maria Malmö Mobile Telephone Study
Official Title
A Randomized Controlled Trial of Interactive Voice Response With and Without Personal Feedback in the Treatment of Adolescents With Substance Use Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present study, in an out-patient setting for substance use treatment in adolescents, examines the effect on treatment retention of a mobile telephone follow-up technique (interactive voice response), with or without personal feedback. Subjects in treatment for substance use disorders will be followed by automated mobile telephone contact with questions about psychiatric symptoms and substance use, and the investigators hypothesize that this technique, including a personal feedback reporting back to the client whether his or her status is changing in one way or another, may increase the treatment retention, possibly by means of an intensified treatment contact.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Substance use disorders, Adolescents, Retention, Mobile telephone, Follow-up, Interactive voice response
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interactive voice response with personal feedback
Arm Type
Experimental
Arm Description
Interactive voice response follows the client twice weekly for 3 months with respect to symptoms and substance use, in both arms. This intervention group also receives a personalized and automated feedback describing whether the symptom status of the patient is better, worse or equal, compared to the preceding follow-up.
Arm Title
Interactive voice response without personal feedback
Arm Type
Active Comparator
Arm Description
This control group is also followed with identical interactive voice response follow-up, addressing symptoms and substance use, but without the personal feedback.
Intervention Type
Behavioral
Intervention Name(s)
Interactive voice response with personal feedback
Intervention Description
Personal feedback is given at the end of each automated telephone follow-up call, and reports back to the patient whether his och her symptom status is better, worse or equal, compared to the previous telephone call.
Intervention Type
Behavioral
Intervention Name(s)
Interactive voice response without personal feedback
Intervention Description
Control condition. Identical follow-up but without personal feedback.
Primary Outcome Measure Information:
Title
Retention in substance use disorder treatment
Description
Duration of retention in treatment and whether the client remains in treatment at 3 months or not.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Improvement in substance use
Description
Do patients in the intervention group improve more than in the control group, with respect to substance use (alcohol/drug use), during the duration of the interactive voice response intervention?
Time Frame
3 months
Title
Improvements in psychiatric symptoms
Description
Do patients in the intervention group improve more than in the control group, with respect to psychiatric symptoms, during the duration of the interactive voice response intervention?
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Clinical course with respect to emergency visits
Time Frame
12 months
Title
Clinical course with respect to hospitalizations
Time Frame
12 months
Title
Clinical course with respect to repeated treatment episodes
Time Frame
12 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient applying for substance use disorder treatment at out-patient facility Maria Malmö, Malmö, Sweden, who are less than 25 years old and who provide written informed consent to participate in the study.
Exclusion Criteria:
Patients who do not provide written informed consent to the study, or whose psychiatric condition or language difficulties make it impossible for them to understand patient information and give informed consent to the study.
Facility Information:
Facility Name
Maria Malmö, Dept of Psychiatry Skane and City of Malmö, Sweden
City
Malmö
State/Province
Skane
ZIP/Postal Code
205 02
Country
Sweden
12. IPD Sharing Statement
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3M Study - Maria Malmö Mobile Telephone Study
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