Substance UseNCT02951858
Substance Use Screening Among Drug User
A study testing Intervention Group in people with Substance Use, run by Shanghai Mental Health Center.
Trial summary
The purpose of this research is to improve the ability of primary medical staffs in screening and intervention for alcohol, benzodiazepines, and other illicit drug use. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Substance Use
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2018
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 18-60 years;
- the patient to the community medical institutions;
- ASSIST score is in 12-27, in a moderate risk;
- voluntary to participate;
- to agree to complete baseline interviews and follow-up studies.
Who cannot join
- unable to complete the questionnaire;
- serious physical illness, action inconvenience.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Screening and Brief Interventions for Substance Use in Primary Medical Institution
The purpose of this research is to improve the ability of primary medical staffs in screening and intervention for alcohol, benzodiazepines, and other illicit drug use.
Read the detailed description
In order to reduce the social and personal harm caused by drugs, it is urgent to strengthen the ability of the primary health institutions in screening and intervention the addictive substances use. Firstly, the investigators will invite 10 primary medical staffs and 10 experts in addition to revise the manual of Alcohol, Smoking, and Substance Use Involvement Screening Test (ASSIST) and Brief Intervention (BI). Then, the investigators will recruit 100 medical staffs to participate the training of ASSIST and BI. Secondly, the researcher will investigate the effects of BI technology in reducing the use of addictive substances, improve the addiction related knowledge of patients through randomized controlled study. Finally, the investigators will collect the research information, revise the manual, and promote the training.
- Conditions
- Substance Use
- Being tested
- Intervention Group, Control Group
- Keywords
- Alcohol,Smoking,and Substance Use Involvement Screening Test, Brief Intervention, Substance Use, Primary Medical and Health Care Institution
- 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.
Intervention GroupBehavioural
The medical staffs who received the training will use the manual of brief intervention to deliver BI and other materials about the harm of substance use.
Control GroupBehavioural
The participants only receive the materials about the harm of substance use.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The medical staffs who received the training will use the manual of brief intervention to deliver it and other materials about the harm of substance use. Receives: Behavioral: Intervention Group |
| Control Group | Active comparator | The participants only receive the materials about the harm of substance use. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Behaviors measured by ASSIST questionnaire
Risk Behaviors will be measured by ASSIST questionnaire.
Measured: 1 month
Knowledge related to Substance Use measured by Knowledge related to Addiction questionnaire
Knowledge related to substance use will be measured by Knowledge related to Addiction questionnaire.
Measured: 1 month
Motivation measured by Pre-treatment Readiness Scale
Motivation will be measured by Pre-treatment Readiness Scale (PRS).
Measured: 1 month
Secondary outcomes (3)
Depression measured by Self-Rating Depression Scale
the change of depression will be measured by Self-Rating Depression Scale (SDS).
Measured: 1 month
Anxiety measured by Self-Rating Anxiety Scale
the change of anxiety will be measured by Self-Rating Anxiety Scale (SAS).
Measured: 1 month
Self-esteem measured by Self-esteem questionnaire
the change of self-esteem will be measured by Self-esteem questionnaire.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies 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
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DU, Jiang, Shanghai Mental Health Center
- Investigators
- Jiang Du, M.D, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951858
- Sponsor's protocol ID
- JDu-003
- Status last verified
- Oct 2016
- First submitted
- 23 Oct 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Brief Interventions for Substance Use in Primary Medical Institution
- ClinicalTrials.gov ID
- NCT02951858
- Acronym / sponsor ID
- JDu-003
- Conditions
- Substance Use
- Keywords
- Alcohol,Smoking,and Substance Use Involvement Screening Test, Brief Intervention, Substance Use, Primary Medical and Health Care Institution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (estimated)
- First posted
- 1 Nov 2016 (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 research is to improve the ability of primary medical staffs in screening and intervention for alcohol, benzodiazepines, and other illicit drug use.
Detailed description
In order to reduce the social and personal harm caused by drugs, it is urgent to strengthen the ability of the primary health institutions in screening and intervention the addictive substances use. Firstly, the investigators will invite 10 primary medical staffs and 10 experts in addition to revise the manual of Alcohol, Smoking, and Substance Use Involvement Screening Test (ASSIST) and Brief Intervention (BI). Then, the investigators will recruit 100 medical staffs to participate the training of ASSIST and BI. Secondly, the researcher will investigate the effects of BI technology in reducing the use of addictive substances, improve the addiction related knowledge of patients through randomized controlled study. Finally, the investigators will collect the research information, revise the manual, and promote the training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Intervention GroupThe medical staffs who received the training will use the manual of brief intervention to deliver it and other materials about the harm of substance use. |
| Control Group | Active comparator | Behavioral: Control GroupThe participants only receive the materials about the harm of substance use. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged 18-60 years;
- the patient to the community medical institutions;
- ASSIST score is in 12-27, in a moderate risk;
- voluntary to participate;
- to agree to complete baseline interviews and follow-up studies.
Key exclusion criteria (2 listed)
- unable to complete the questionnaire;
- serious physical illness, action inconvenience.
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 |
|---|---|---|
| Intervention GroupThe medical staffs who received the training will use the manual of brief intervention to deliver BI and other materials about the harm of substance use. | Behavioural | Intervention Group |
| Control GroupThe participants only receive the materials about the harm of substance use. | Behavioural | Control Group |
Primary outcome
Risk Behaviors measured by ASSIST questionnaire
Time frame: 1 month
Risk Behaviors will be measured by ASSIST questionnaire.
Knowledge related to Substance Use measured by Knowledge related to Addiction questionnaire
Time frame: 1 month
Knowledge related to substance use will be measured by Knowledge related to Addiction questionnaire.
Motivation measured by Pre-treatment Readiness Scale
Time frame: 1 month
Motivation will be measured by Pre-treatment Readiness Scale (PRS).
3 secondary outcomes
Depression measured by Self-Rating Depression Scale
Time frame: 1 month
Anxiety measured by Self-Rating Anxiety Scale
Time frame: 1 month
Self-esteem measured by Self-esteem questionnaire
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Jiang Du, M.D principal investigator
Shanghai Mental Health Center
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Substance Use, run by Shanghai Mental Health Center.
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 5 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: status not confirmed, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Du, M.D (18017311220, dujiangdou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk Behaviors measured by ASSIST questionnaire (time frame: 1 month). The study lists 3 primary outcomes in all. 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 1 Nov 2016.