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Effectiveness of Adolescent-Community Reinforcement Approach on Treatment Outcome Among Adolescents with Cannabis Use Disorder

Protocol summary

Study aim
The purpose of this study is to investigate the effectiveness of Adolescent Community Reinforcement Approach (ACRA) on treatment outcome in adolescents with Cannabis use disorder.
Design
Clinical trial with a control treatment as usual group, parallel groups, without blinding on 30 adolescent patients.
Settings and conduct
The location of the research is the treatment centers for addiction and centers providing services to teenagers. Adolescents who have met the criteria, will be placed in two intervention (Adolescent Community Reinforcement Approach) and control groups ( treatment as usual) in a quasi-random manner.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having a cannabis use disorder and being in the age range of 15 to 19 years old. Exclusion criteria are having psychotic symptoms, having Autism Spectrum Disorder, having Bipolar and Related Disorders and Intellectual Disability and abusing opioid and stimulant substances
Intervention groups
The intervention group will receive adolescent community reinforcement approach which includes 12 one-hour individual sessions with the adolescent, 2 sessions with the caregiver, and 2 joint caregivers and the adolescent sessions. Intervention procedures include functional analysis of substance use and prosocial behaviors, self-assessment of happiness, planning for social recreation, relapse prevention, communication skills, problem solving, finding a job, anger management, crisis intervention, communication skills in caregivers and urine testing. The control group will receive the usual treatments including psychoeducation about substance use, managing cravings and coping strategies training.
Main outcome variables
abstinence rate; substance use problems; psychological symptoms; relation with parents; health promoting life style; retention rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230423057978N1
Registration date: 2023-05-19, 1402/02/29
Registration timing: registered_while_recruiting

Last update: 2023-05-19, 1402/02/29
Update count: 0
Registration date
2023-05-19, 1402/02/29
Registrant information
Name
Najmeh Khosrovanmehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8843 0847
Email address
khosrovanmehr.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Adolescent-Community Reinforcement Approach on Treatment Outcome Among Adolescents with Cannabis Use Disorder
Public title
Effect of Adolescent-Community Reinforcement Approach on Cannabis Use
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a cannabis use disorder Being in the age range of 15 to 19 years old
Exclusion criteria:
having psychotic symptoms having Autism Spectrum Disorder Having Bipolar and Related Disorders Intellectual Disability Abusing Opioid and Stimulant substances
Age
From 15 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not 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
Research Ethics Committees of Iran University of of Medical Sciences
Street address
Research and Technology Vice-Chancellor, Central Headquarters Building, Hemat Highway, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-11-02, 1401/08/11
Ethics committee reference number
IR.IUMS.REC.1401.621

Health conditions studied

1

Description of health condition studied
Cannabis Use Disorder
ICD-10 code
F12.2
ICD-10 code description
Cannabis dependence

Primary outcomes

1

Description
Substance use problem
Timepoint
Before intervention, Immediately After Intervention, 3 Months after intervention
Method of measurement
Substance Problem Scale

2

Description
Abstinence Rate
Timepoint
Before intervention, Immediately After Intervention, 3 Months after intervention
Method of measurement
Urine Test Kit for Cnnabis

Secondary outcomes

1

Description
Psychological symptoms ( Depression, Anxiety, Stress)
Timepoint
Before intervention, Immediately after intervention, 3 Months after intervention
Method of measurement
Depression Anxiety Stress Scale

2

Description
Parent- child interaction
Timepoint
Before intervention, Immediately after intervention, 3 Months after intervention
Method of measurement
Parent - Child Interaction Scale

3

Description
Health promoted life style
Timepoint
Before intervention, Immediately after intervention, 3 Months after intervention
Method of measurement
Health promoted life style Questionnaire

4

Description
Retention
Timepoint
Immediately after intervention
Method of measurement
The total number of days from the start of treatment to the last treatment session

Intervention groups

1

Description
Intervention group: Treatment by Adolescent- Community Reinforcement Approach that includes 12 one-hour individual sessions with adolescents and 2 sessions with caregivers (parents) and 2 joint sessions between caregivers (parents) and adolescents. These meetings are held weekly over a period of 12 to 14 weeks. The duration of the sessions can be changed based on the needs of the adolescent or caregiver or the discretion of the therapist. This program has 19 procedures that the therapist chooses the appropriate procedure according to the client's needs during the implementation of the intervention. Intervention procedures and case management activities include functional analysis of substance use or prosocial behaviors, self-assessment of happiness, counseling goals, planning for socially acceptable recreation, relapse prevention skills, communication skills, problem solving skills, family relationship skills (such as problem solving, communication and happy relationships), setting homework, homework review, finding a job skills, anger management, crisis intervention, communication skills in caregivers, parent-adolescent communication skills, systematic encouragement and urine testing. Adolescents who receive 10 or more of these procedures during their treatment and attend at least 7 treatment sessions are more likely to stay in recovery for a long time.
Category
Behavior

2

Description
Control group: Treatment as usual that include psychoeducation about substance use and behavioral techniques for managing cravings and teaching coping strategies. Adolescents participate in at least 5 , 45-minute therapy sessions weekly. Based on the client's needs and the therapist's discretion, the number of sessions can be increased up to 8 sessions. The treatment period will last between 5 and 8 weeks.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Association for protection of child laborers
Full name of responsible person
Najmeh Khosrovanmehr
Street address
No. 17, 3rd Alley, Asad Abadi Ave.
City
تهران
Province
Tehran
Postal code
1433643177
Phone
+98 21 8810 5127
Email
nkhosrovan@yahoo.com

2

Recruitment center
Name of recruitment center
Toloo Bi-neshanha society
Full name of responsible person
Najmeh Khosrovanmehr
Street address
No.6, in front of the clinic of Qasem-Ebn-Hasan Mosque , Shahid Salehi Alley, Local access, before the exit of Imam Ali (AS) North, Shahid Mahallati Highway East to West
City
Tehran
Province
Tehran
Postal code
1767914363
Phone
+98 21 3317 2171
Email
nkhosrovan@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza Falak
Street address
5th floor of the central headquarters, Iran University of Medical Sciences, next to Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Email
falak.r@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Najmeh Khosrovanmehr
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 89, 3rd Andishe Alley, North Sohrevardi
City
Tehran
Province
Tehran
Postal code
1569637811
Phone
+98 21 8843 0847
Email
nkhosrovan@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Najmeh Khosrovanmehr
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 89, 3rd Andishe Alley, North Sohrevardi Street
City
Tehran
Province
Tehran
Postal code
1569637811
Phone
+98 21 8843 0847
Fax
Email
khosrovanmehr.n@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Najmeh Khosrovanmehr
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 89, 3rd Andishe Alley, North Sohrevardi Street
City
Tehran
Province
Tehran
Postal code
1569637811
Phone
+98 21 8843 0847
Fax
Email
khosrovanmehr.n@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It is possible to misuse individual raw data.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Results from statistical analysis and reports of clinical outcomes will be available. Also, the informed consent form will be available for the Research Ethics Committee of Iran University of Medical Sciences
When the data will become available and for how long
The beginning of the period of access to the findings is one month after the publication of the data in the form of theses and articles.
To whom data/document is available
All researchers and health policy makers can access clinical findings and statistical analysis results. The informed consent form will only be available to the Research Ethics Committee of Iran University of Medical Sciences.
Under which criteria data/document could be used
The data will be available for stablishing meta-analyses, as well as for developing new protocols and presenting of reports at health-related conferences.
From where data/document is obtainable
Applicants can contact the following email addresses. Name of the respondent: Najmeh Khosrovanmehr khosrovanmehr.n@iums.ac.ir nkhosrovan@yahoo.com
What processes are involved for a request to access data/document
Answering the requests and sending the desired data will be done by email and will take about a month.
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