Substance Use DisordersNCT01706380
3M Study - Maria Malmö Mobile Telephone Study
A study testing Interactive voice response with personal feedback and Interactive voice response without personal feedback in people with Substance Use Disorders, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Interactive voice response with personal feedback and Interactive voice response without personal feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Maria Malmö, Dept of Psychiatry Skane and City of Malmö, Sweden
Malmö, Skåne County, 205 02
About this 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
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.
- Conditions
- Substance Use Disorders
- Being tested
- Interactive voice response with personal feedback, Interactive voice response without personal feedback
- Keywords
- Substance use disorders, Adolescents, Retention, Mobile telephone, Follow-up, Interactive voice response
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive voice response with personal feedbackBehavioural
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.
Interactive voice response without personal feedbackBehavioural
Control condition. Identical follow-up but without personal feedback.
| Study group | Role | What they receive |
|---|---|---|
| Interactive voice response with personal feedback | Experimental | 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. Receives: Behavioral: Interactive voice response with personal feedback |
| Interactive voice response without personal feedback | Active comparator | This control group is also followed with identical interactive voice response follow-up, addressing symptoms and substance use, but without the personal feedback. Receives: Behavioral: Interactive voice response without personal feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in substance use disorder treatment
Duration of retention in treatment and whether the client remains in treatment at 3 months or not.
Measured: 3 months
Secondary outcomes (2)
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?
Measured: 3 months
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?
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders C Håkansson, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706380
- Sponsor's protocol ID
- 3M Study
- Status last verified
- Mar 2021
- First submitted
- 8 Oct 2012
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Interactive Voice Response With and Without Personal Feedback in the Treatment of Adolescents With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT01706380
- Acronym / sponsor ID
- 3M Study
- Conditions
- Substance Use Disorders
- Keywords
- Substance use disorders, Adolescents, Retention, Mobile telephone, Follow-up, Interactive voice response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive voice response with personal feedback | Experimental | Behavioral: Interactive voice response with personal feedbackInteractive 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. |
| Interactive voice response without personal feedback | Active comparator | Behavioral: Interactive voice response without personal feedbackThis control group is also followed with identical interactive voice response follow-up, addressing symptoms and substance use, but without the personal feedback. |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive voice response with personal feedbackPersonal 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. | Behavioural | Interactive voice response with personal feedback |
| Interactive voice response without personal feedbackControl condition. Identical follow-up but without personal feedback. | Behavioural | Interactive voice response without personal feedback |
Primary outcome
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.
2 secondary outcomes
Improvement in substance use
Time frame: 3 months
Improvements in psychiatric symptoms
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive voice response with personal feedback and Interactive voice response without personal feedback in people with Substance Use Disorders, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in substance use disorder treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.