AffectNCT01727882
Automated Telephone Follow-up in the Swedish Prison and Probation Services
A study testing Brief feedback and Daily assessments in people with Affect and Alcohol Consumption, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate whether automated telephony may be used for daily assessments of paroled offenders, and whether a brief intervention based on these daily assessments may result in a more positive development compared to daily assessments only. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Affect, Alcohol Consumption, Substance Abuse
- What is being tested?
- Brief feedback and Daily assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2009to Sep 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Convicted criminals subject to parole
- Access to a mobile telephone
- Assigned parole officer at parole
Who cannot join
- No knowledge of spoken Swedish
- Additional intervention such as intensive supervision with electronic monitoring, or in-patient care at a health and rehabilitation clinic
Trial locations and contacts
1 site in 1 country.
Sweden1 site
The Swedish Prison and Probation Services, Region South and Region East
Norrköping
About this study
Official title: Automated Telephone Follow-up in the Swedish Prison and Probation Services. A Randomized Controlled Trail.
The purpose of this study is to investigate whether automated telephony may be used for daily assessments of paroled offenders, and whether a brief intervention based on these daily assessments may result in a more positive development compared to daily assessments only.
Read the detailed description
To study whether automated telephony could be used in paroled offenders to perform daily assessment of variables associated with recidivism in crime and to study the effects of a brief intervention based on these assessments during 30 days following probation.
- Conditions
- Affect, Alcohol Consumption, Substance Abuse
- Being tested
- Brief feedback, Daily assessments
- Keywords
- Paroled offenders, Interactive Voice Response, Stress, Mental symptoms, Alcohol consumption, Substance use
- Medical subject headings
- Alcohol Drinking, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief feedbackBehavioural
A brief feedback was given on the results of the daily assessments, including a recommendation to the paroled offender and a email report was sent to the probation officer.
Daily assessmentsBehavioural
Daily assessment of stress, mental symptoms, alcohol and substance use during 30 consecutive days after parole.
| Study group | Role | What they receive |
|---|---|---|
| Daily Assessments & Brief Feedback | Experimental | Daily assessments during 30 days after parole and a feedback intervention based on these daily assessments. Receives: Behavioral: Brief feedback; Behavioral: Daily assessments |
| Daily assessments | Active comparator | Daily assessments during 30 days after parole. Receives: Behavioral: Daily assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental symptoms, SCL-8D
Mental Symptoms, assessed with SCL-8D (Fink et al. A Nordic multicentre investigation. Part I: Method and prevalence of psychiatric morbidity. Acta Psychiatrica Scandinavica. 1995;92(6):409-418).
Measured: During 30 days after probation
Secondary outcomes (4)
Stress
Stress assessed with the Arnetz and hasson stress questionnaire(Andersson C et al. Measurement properties of the Arnetz and Hasson stress questionnaire in Swedish university freshmen. Scandinavian Journal of Public Health. 2009;37(3):273-279)
Measured: During 30 days after probation
Stress
Daily Assessment of Daily Experience (Stone AA, Neale JM. Development of a methodology for assessing daily experiences. In: Baum A, Singer J, eds. Advances in Environmental Psychology: Environment and Health. Vol 4. New York: Erlbaum; 1982:49-83).
Measured: During 30 days after probation
Desire to use alcohol and drugs
Desire to use alcohol and drugs (Bohn MJ, Krahn DD, Staehler BA. Development and initial validation of a measure of drinking urges in abstinent alcoholics. Alcoholism: Clinical and Experimental Research. 1995;19(3):600-606).
Measured: During 30 days after probation
Current use of alcohol and drugs
Current use was then assessed by simply asking whether the offender had drunk alcohol or used any drugs the previous day.
Measured: During 30 days after probation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startDec 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AffectStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Malmö University
- Responsible party
- Principal investigator, Claes Andersson, Region Skane
- Investigators
- Claes Andersson, PhD, Principal investigator, Lund university and Malmö university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727882
- Sponsor's protocol ID
- 535629
- Other IDs
- 535629
- Status last verified
- Nov 2012
- First submitted
- 4 Nov 2012
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Telephone Follow-up in the Swedish Prison and Probation Services. A Randomized Controlled Trail.
- ClinicalTrials.gov ID
- NCT01727882
- Acronym / sponsor ID
- 535629
- Conditions
- Affect, Alcohol Consumption, Substance Abuse
- Keywords
- Paroled offenders, Interactive Voice Response, Stress, Mental symptoms, Alcohol consumption, Substance use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, Malmö University
- Study start
- Dec 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 16 Nov 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 purpose of this study is to investigate whether automated telephony may be used for daily assessments of paroled offenders, and whether a brief intervention based on these daily assessments may result in a more positive development compared to daily assessments only.
Detailed description
To study whether automated telephony could be used in paroled offenders to perform daily assessment of variables associated with recidivism in crime and to study the effects of a brief intervention based on these assessments during 30 days following probation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily Assessments & Brief Feedback | Experimental | Behavioral: Brief feedback, Behavioral: Daily assessmentsDaily assessments during 30 days after parole and a feedback intervention based on these daily assessments. |
| Daily assessments | Active comparator | Behavioral: Daily assessmentsDaily assessments during 30 days after parole. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Convicted criminals subject to parole
- Access to a mobile telephone
- Assigned parole officer at parole
Key exclusion criteria (2 listed)
- No knowledge of spoken Swedish
- Additional intervention such as intensive supervision with electronic monitoring, or in-patient care at a health and rehabilitation clinic
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 |
|---|---|---|
| Brief feedbackA brief feedback was given on the results of the daily assessments, including a recommendation to the paroled offender and a email report was sent to the probation officer. | Behavioural | Daily Assessments & Brief Feedback |
| Daily assessmentsDaily assessment of stress, mental symptoms, alcohol and substance use during 30 consecutive days after parole. | Behavioural | Daily Assessments & Brief Feedback, Daily assessments |
Primary outcome
Mental symptoms, SCL-8D
Time frame: During 30 days after probation
Mental Symptoms, assessed with SCL-8D (Fink et al. A Nordic multicentre investigation. Part I: Method and prevalence of psychiatric morbidity. Acta Psychiatrica Scandinavica. 1995;92(6):409-418).
4 secondary outcomes
Stress
Time frame: During 30 days after probation
Stress
Time frame: During 30 days after probation
Desire to use alcohol and drugs
Time frame: During 30 days after probation
Current use of alcohol and drugs
Time frame: During 30 days after probation
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 Nov 2012.
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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.
Claes Andersson, PhD principal investigator
Lund university and Malmö university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief feedback and Daily assessments in people with Affect and Alcohol Consumption, 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 3 inclusion and 2 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 Nov 2012. 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?
Mental symptoms, SCL-8D (time frame: During 30 days after probation). 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 Nov 2012.