3M Study - Maria Malmö Mobile Telephone Study

March 12, 2021 updated by: Anders C Håkansson, Region Skane

A Randomized Controlled Trial of Interactive Voice Response With and Without Personal Feedback in the Treatment of Adolescents With Substance Use Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • 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 Locations

  • Sweden
    • Skane
      • Malmö, Skane, Sweden, 205 02
        • Maria Malmö, Dept of Psychiatry Skane and City of Malmö, Sweden

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

Ages Eligible for Study

No older than 25 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Interactive voice response with personal feedback
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.
Behavioral: Interactive voice response with personal feedback
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.
ACTIVE_COMPARATOR: Interactive voice response without personal feedback
This control group is also followed with identical interactive voice response follow-up, addressing symptoms and substance use, but without the personal feedback.
Behavioral: Interactive voice response without personal feedback
Control condition. Identical follow-up but without personal feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention in substance use disorder treatment
Time Frame: 3 months
Duration of retention in treatment and whether the client remains in treatment at 3 months or not.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in substance use
Time Frame: 3 months
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?
3 months
Improvements in psychiatric symptoms
Time Frame: 3 months
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?
3 months

Other Outcome Measures

Outcome Measure
Time Frame
Clinical course with respect to emergency visits
Time Frame: 12 months
12 months
Clinical course with respect to hospitalizations
Time Frame: 12 months
12 months
Clinical course with respect to repeated treatment episodes
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Region Skane

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)

October 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

October 8, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (ESTIMATE)

October 15, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3M Study

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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