1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
06 Nov 2022
Designing and evaluation of “in-home brief motivational intervention”
based on social work among non-treatment-seeking drug users to enter to the treatment cycle
Protocol summary
Summary
Aim: aim of this study is to design and evaluate a motivational intervention for treatment of men who will be substance abuser and non-treatment-seeking. The present intervention will be done at their home and this approach will be based on social work. Inclusion and exclusion criteria: The participants will be men, substance abuser and non-treatment-seeking.
Participants won’t be eligible if 1) They will be aggressive, 2) They will have a self-inflicted injury, 3) They will inflict a wound on somebody or 4) They will have a psychiatric disorder. Statistical population: The present intervention will include all of the men who will be substance abusers and won’t be treatment-seeking who their families will participate in training sessions for families in 2014 summer. These training sessions will be held in Tehran. Samples: Sampling will be done among all eligible people who will be volunteers by counting all.
Intervention: All of the samples will participate in one to three sessions of the present intervention which will be include motivational interview at substance abuser’s home and they will be encouraged to enter in cycle of treatment that will use motivational technics. In these sessions the effective members of family should be present. Control group will receive no intervention. Both group’s family will attend in training sessions once a week that will be held by research team. These training sessions will be as same as the other usual family training sessions. Intervention outcomes: The entrance of the samples in cycle of treatment, will be the positive outcomes of this intervention.
General information
Acronym
IRCT registration information
IRCT registration number: IRCT2015012020733N1
Registration date: 2015-03-31, 1394/01/11 Registration timing: retrospective
Last update:
Update count: 0 Registration date
2015-03-31, 1394/01/11 Registrant information
Name
Morteza Danaeifar
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of) Phone
+98 21 4400 3836 Email address
danaeefar.m@uswr.ac.ir Recruitment status
Recruitment complete Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date 2014-06-22, 1393/04/01
Expected recruitment end date 2014-08-23, 1393/06/01 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Designing and evaluation of “in-home brief motivational
2 intervention” based on social work among non-
treatment-seeking drug users to enter to the treatment cycle
Public title
“in-home brief motivational intervention” among non- treatment-seeking drug users
Purpose Treatment
Inclusion/Exclusion criteria
The participants will be men, substance abuser and non- treatment-seeking. Participants won’t be eligible if 1) They will be aggressive, 2) They will have a self-inflicted injury, 3) They will inflict a wound on somebody or 4) They will have a psychiatric disorder (according to social work, psychiatrist and psychology diagnosis)
Age
No age limit Gender
Male Phase
2
Groups that have been masked No information
Sample size
Target sample size: 56
Randomization (investigator's opinion) Randomized
Randomization description Blinding (investigator's opinion)
Not blinded Blinding description Placebo
Not used Assignment
Parallel
Other design features
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Ave., daneshjoo Blvd.,Evin City
Tehran Postal code
1985713834 Approval date
2014-04-06, 1393/01/17
Ethics committee reference number uswr.rec.1393.179
Health conditions studied
1
Description of health condition studied addiction
ICD-10 code (F10-F19)
ICD-10 code description
Mental and behavioural disorders due to psychoactive substance use
Primary outcomes
1
Description
Entrance to treatment cycle Timepoint
In the first week after performance of intervention Method of measurement
Visual scale and follow up
Secondary outcomes
1
Description
Staying in cycle of treatment Timepoint
Three month after performance of intervention Method of measurement
following up with telephone
Intervention groups
1
Description
Experimental group: All of the samples will participate in one to three sessions of the present intervention which will be include motivational interview at substance abuser’s home and they will be encouraged to enter in cycle of treatment that will use motivational technics. In these sessions the effective members of family should be present.Families will attend in training sessions once a week that will be held by research team. These training sessions will be as same as the other usual family training sessions.
Category
Treatment - Other
2
Description
Control group: Control group will receive no intervention but their families once a week will participate in training sessions which will be held by research team as same as the experimental group’s family.
Category
Treatment - Other
3
Recruitment centers
1
Recruitment center
Name of recruitment center Faraz Social Work Clinic
Full name of responsible person Morteza Danaeifar
Street address
Unite8، First Floor، No. 1034، Building 1134، Razi street corner، after Vali Asr street، Enghelab street،
Tehran City
Tehran
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person Morteza Danaeifar
Street address
kodakyar Ave., daneshjoo Blvd.,Evin City
Tehran Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation Sciences Proportion provided by this source
100
Public or private sector empty
Domestic or foreign origin empty
Category of foreign source of funding empty
Country of origin
Type of organization providing the funding empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person Morteza Danaeifar
Position
Graduate student
Other areas of specialty/work Street address
kodakyar Ave., daneshjoo Blvd.,Evin
City Tehran Postal code
1985713834 Phone
+98 21 2218 0064 Fax
danaeefar.morteza@yahoo.com Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person Morteza Danaeifar
Position
Graduate student
Other areas of specialty/work Street address
kodakyar Ave., daneshjoo Blvd.,Evin City
Tehran Postal code
1985713834 Phone
+98 21 4400 3836 Fax
danaeefar.morteza@yahoo.com Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person Morteza Danaeifar
Position
Graduate student
Other areas of specialty/work Street address
kodakyar Ave., daneshjoo Blvd.,Evin City
Tehran Postal code
1985713834 Phone
+98 21 4400 3836 Fax
danaeefar.morteza@yahoo.com Web page address
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Sharing plan
Deidentified Individual Participant Data Set (IPD) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty Data Dictionary
empty
