Drug UseNCT01969305
Youth Drug Abuse Prevention in Kazakhstan
A study testing Kazakhstani Family Together in people with Drug Use, run by University of Chicago at 1 site in Kazakhstan.
Trial summary
This pilot study will adapt and test the feasibility and estimate the effect size parameters of Kazakhstani Family Together (KFT), a family-based multi-media intervention designed to reduce sexual and drug-related risks for HIV infection among at-risk 14-17 year old females and males living in communities highly… Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Use
- What is being tested?
- Kazakhstani Family Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteKazakhstan
- Study dates
- Jan 2014to May 2016
- 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 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Youth are between the ages of 14-17.
- Youth exhibits one of the following risk factors: substance-using peers or friends, parental history of drug use, parental history of alcohol problems, parental criminal history, adolescent's history of drug use, running away from home, school drop-out or history of sexual activity.
- You and caregiver are able to speak and read Russian.
- Both youth and caregiver (parent or other caregiving adult family member) can commit to study participation.
- Youth and caregiver do not plan to move in the next 6 months.
Who cannot join
- Youth are under the age of 14 or over the age of 17.
- Youth does not exhibit one of the aforementioned risk factors.
- Youth and caregiver do not speak and read Russian.
- Youth and caregiver are unable to commit to study participation.
- Youth or caregiver has plans to move within the next 6 months.
- Youth or caregiver has a cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
Columbia University Global Heath Research Center of Central Asia
Almaty
About this study
Official title: A Computerized Family-Based Youth HIV and Drug Abuse Prevention in Kazakhstan
This pilot study will adapt and test the feasibility and estimate the effect size parameters of Kazakhstani Family Together (KFT), a family-based multi-media intervention designed to reduce sexual and drug-related risks for HIV infection among at-risk 14-17 year old females and males living in communities highly affected by heroin trade and use in Almaty, Kazakhstan.
Read the detailed description
The purpose of this study is to adapt an evidence-based HIV and substance use prevention intervention for most at-risk adolescents and their caregivers (parents or other adult family members) from drug-risk communities in Kazakhstan. Located on major drug trafficking routes (between Afghanistan, the world's largest opium producer, and Russia), Central Asia and Kazakhstan, in particular, face one of the fastest growing rates of HIV infection in the world disproportionately affecting young people ages 15-29. Youth exposed to drugs at home and in the community are particularly at risk.
The country's HIV prevention efforts for youth are limited to a knowledge-based approach, which does not equip at-risk youth with skills required to deal with situations of risk exposure. Parents or other caregivers, who represent a significant protective force in a family-oriented culture of Central Asia, are largely excluded from youth prevention efforts in Kazakhstan.
KFT is a family-based multi-media intervention designed to reduce sexual and drug-related risks for HIV infection among at-risk adolescents. To address the dual risk of HIV and substance use, the proposed intervention combines empirically tested skills-based and family involvement approaches and utilizes multi-media computer technology to develop an engaging and potentially cost-effective tool with high fidelity and easy scalability. During each of the sessions, youth and caregivers will participate in interactive computer activities to learn skills and have conversations focused on risky behaviors.
During the development stage, the US and Kazakhstani investigative team will conduct formative research and will work closely with the local Community Collaborative Board to adapt the intervention to the cultural context of at-risk families in Kazakhstan.
Further, the KFT intervention will be tested in a pilot Randomized Controlled Trial with 248 adolescents and 248 of their caregivers. Intervention arm adolescent-caregiver pairs will receive three 45-minute interactive multi-media sessions with avatars customized to participants' gender that will focus on risk reduction self-efficacy, resistance to peer pressure, and caregiver-adolescent communication, support and monitoring. Adolescents from both intervention and control arms will receive the usual care services available for at-risk youth, which includes health education sessions on HIV and drug use delivered by peer educators and outreach workers.
- Conditions
- Drug Use
- Being tested
- Kazakhstani Family Together, Usual Care Alone
- Keywords
- Kazakhstan, Central Asia, HIV prevention, Adolescents, Sexual risk behaviors, Drug abuse prevention, Multi-media intervention, Drug use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kazakhstani Family TogetherBehavioural
Adolescent-caregiver pairs will receive three 45-minute interactive multi-media sessions with avatars customized to participants' gender that will focus on risk reduction self-efficacy, resistance to peer pressure, decision-making skills and caregiver-adolescent communication, support and monitoring to strengthen youth's relationships with caregivers and reduce youth's risks of drug use and sexual risk behaviors. Through the multimedia tool, participants will confront a series of sexual risks and substance use related situations and will practice their listening, empathy, assertiveness, refusal, and other interpersonal skills. Each caregiver-youth pair will work jointly and engage in discussions, exercises, and behavioral rehearsal as directed by the program.
Usual Care AloneBehavioural
Adolescents from both study arms will receive the usual care, a health education program about how to prevent drug use and HIV/STIs (sexually transmitted infections). The health education curriculum is delivered in a group format by trained peer educators and outreach workers. The curriculum consists of three 45-minute sessions that include lectures and interactive quizzes about drugs and HIV. These three sessions include information on the following topics:
- Facts and Myth about HIV. HIV/STIs modes of transmission;
- Prevention of HIV. Abstinence and Safe Sex. Attitudes and values about sexuality, sexual risk behaviors, and condom use;
- Knowledge, attitudes and beliefs about drinking and drug use. Risks and consequences of drug use.
| Study group | Role | What they receive |
|---|---|---|
| Kazakhstani Family Together (KFT) | Experimental | Usual Care Plus KFT: Family-based multi-media HIV and drug abuse prevention intervention Receives: Behavioral: Kazakhstani Family Together |
| Health education curriculum | Experimental | Usual Care Alone: Health education curriculum on HIV and drug use prevention Receives: Behavioral: Usual Care Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in onset and 30-day alcohol and drug use from baseline to 6 months
Measures will ask youth to report the frequency and quantity of alcohol and drug use in the past 30 days (number of alcoholic drinks, puffs of marijuana, or initiation of injection drug use). Substance use includes specific probes, including street names for alcohol, marijuana, ecstasy, cocaine, injecting drug use, heroin, inhalants, hallucinogens, and other drugs as appropriate to the context.
Measured: Up to 6-months
Secondary outcomes (1)
Change in onset and sexual risk behaviors from baseline to 6 months
Measures will ask youth to report a history of sexual intercourse and the age of onset, proportion of unprotected acts in past 30 days, frequency of condom use in past 30 days, condom use during the last episode, and number of sexual partners in past 30 days.
Measured: Up to 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drug UseStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Columbia University
- Responsible party
- Sponsor
- Investigators
- Leyla Ismayilova, PhD, Principal investigator, University of Chicago School of Social Service Administration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969305
- Sponsor's protocol ID
- IRB13-0841
- Other IDs
- R34DA033201
- Status last verified
- Sep 2018
- First submitted
- 6 Jul 2013
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ismayilova L, Terlikbayeva A. Building Competencies to Prevent Youth Substance Use in Kazakhstan: Mixed Methods Findings From a Pilot Family-Focused Multimedia Trial. J Adolesc Health. 2018 Sep;63(3):301-312. doi: 10.1016/j.jadohealth.2018.04.005. Epub 2018 Jul 10.
PubMed 30006027Ismayilova L, Terlikbayeva A, Rozental Y. Computerized intervention to prevent drug use among at-risk adolescents in Central Asia: Preliminary family-level findings from a pilot mixed methods trial. Int J Drug Policy. 2019 Jun;68:75-85. doi: 10.1016/j.drugpo.2019.03.022. Epub 2019 Apr 16.
PubMed 31003194
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Computerized Family-Based Youth HIV and Drug Abuse Prevention in Kazakhstan
- ClinicalTrials.gov ID
- NCT01969305
- Acronym / sponsor ID
- IRB13-0841
- Conditions
- Drug Use
- Keywords
- Kazakhstan, Central Asia, HIV prevention, Adolescents, Sexual risk behaviors, Drug abuse prevention, Multi-media intervention, Drug use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Columbia University
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Oct 2013 (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.
This pilot study will adapt and test the feasibility and estimate the effect size parameters of Kazakhstani Family Together (KFT), a family-based multi-media intervention designed to reduce sexual and drug-related risks for HIV infection among at-risk 14-17 year old females and males living in communities highly affected by heroin trade and use in Almaty, Kazakhstan.
Detailed description
The purpose of this study is to adapt an evidence-based HIV and substance use prevention intervention for most at-risk adolescents and their caregivers (parents or other adult family members) from drug-risk communities in Kazakhstan. Located on major drug trafficking routes (between Afghanistan, the world's largest opium producer, and Russia), Central Asia and Kazakhstan, in particular, face one of the fastest growing rates of HIV infection in the world disproportionately affecting young people ages 15-29. Youth exposed to drugs at home and in the community are particularly at risk.
The country's HIV prevention efforts for youth are limited to a knowledge-based approach, which does not equip at-risk youth with skills required to deal with situations of risk exposure. Parents or other caregivers, who represent a significant protective force in a family-oriented culture of Central Asia, are largely excluded from youth prevention efforts in Kazakhstan.
KFT is a family-based multi-media intervention designed to reduce sexual and drug-related risks for HIV infection among at-risk adolescents. To address the dual risk of HIV and substance use, the proposed intervention combines empirically tested skills-based and family involvement approaches and utilizes multi-media computer technology to develop an engaging and potentially cost-effective tool with high fidelity and easy scalability. During each of the sessions, youth and caregivers will participate in interactive computer activities to learn skills and have conversations focused on risky behaviors.
During the development stage, the US and Kazakhstani investigative team will conduct formative research and will work closely with the local Community Collaborative Board to adapt the intervention to the cultural context of at-risk families in Kazakhstan.
Further, the KFT intervention will be tested in a pilot Randomized Controlled Trial with 248 adolescents and 248 of their caregivers. Intervention arm adolescent-caregiver pairs will receive three 45-minute interactive multi-media sessions with avatars customized to participants' gender that will focus on risk reduction self-efficacy, resistance to peer pressure, and caregiver-adolescent communication, support and monitoring. Adolescents from both intervention and control arms will receive the usual care services available for at-risk youth, which includes health education sessions on HIV and drug use delivered by peer educators and outreach workers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kazakhstani Family Together (KFT) | Experimental | Behavioral: Kazakhstani Family TogetherUsual Care Plus KFT: Family-based multi-media HIV and drug abuse prevention intervention |
| Health education curriculum | Experimental | Behavioral: Usual Care AloneUsual Care Alone: Health education curriculum on HIV and drug use prevention |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Youth are between the ages of 14-17.
- Youth exhibits one of the following risk factors: substance-using peers or friends, parental history of drug use, parental history of alcohol problems, parental criminal history, adolescent's history of drug use, running away from home, school drop-out or history of sexual activity.
- You and caregiver are able to speak and read Russian.
- Both youth and caregiver (parent or other caregiving adult family member) can commit to study participation.
- Youth and caregiver do not plan to move in the next 6 months.
Key exclusion criteria (6 listed)
- Youth are under the age of 14 or over the age of 17.
- Youth does not exhibit one of the aforementioned risk factors.
- Youth and caregiver do not speak and read Russian.
- Youth and caregiver are unable to commit to study participation.
- Youth or caregiver has plans to move within the next 6 months.
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 |
|---|---|---|
| Kazakhstani Family TogetherAdolescent-caregiver pairs will receive three 45-minute interactive multi-media sessions with avatars customized to participants' gender that will focus on risk reduction self-efficacy, resistance to peer pressure, decision-making skills and caregiver-adolescent communication, support and monitoring to strengthen youth's relationships with caregivers and reduce youth's risks of drug use and sexual risk behaviors. Through the multimedia tool, participants will confront a series of sexual risks and substance use related situations and will practice their listening, empathy, assertiveness, refusal, and other interpersonal skills. Each caregiver-youth pair will work jointly and engage in discussions, exercises, and behavioral rehearsal as directed by the program. | Behavioural | Kazakhstani Family Together (KFT) |
| Usual Care AloneAdolescents from both study arms will receive the usual care, a health education program about how to prevent drug use and HIV/STIs (sexually transmitted infections). The health education curriculum is delivered in a group format by trained peer educators and outreach workers. The curriculum consists of three 45-minute sessions that include lectures and interactive quizzes about drugs and HIV. These three sessions include information on the following topics: 1. Facts and Myth about HIV. HIV/STIs modes of transmission; 2. Prevention of HIV. Abstinence and Safe Sex. Attitudes and values about sexuality, sexual risk behaviors, and condom use; 3. Knowledge, attitudes and beliefs about drinking and drug use. Risks and consequences of drug use. | Behavioural | Health education curriculum |
Primary outcome
Change in onset and 30-day alcohol and drug use from baseline to 6 months
Time frame: Up to 6-months
Measures will ask youth to report the frequency and quantity of alcohol and drug use in the past 30 days (number of alcoholic drinks, puffs of marijuana, or initiation of injection drug use). Substance use includes specific probes, including street names for alcohol, marijuana, ecstasy, cocaine, injecting drug use, heroin, inhalants, hallucinogens, and other drugs as appropriate to the context.
1 secondary outcome
Change in onset and sexual risk behaviors from baseline to 6 months
Time frame: Up to 6-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 22 May 2019.
- Results publication: PubMed 30006027Ismayilova L, Terlikbayeva A. Building Competencies to Prevent Youth Substance Use in Kazakhstan: Mixed Methods Findings From a Pilot Family-Focused Multimedia Trial. J Adolesc Health. 2018 Sep;63(3):301-312. doi: 10.1016/j.jadohealth.2018.04.005. Epub 2018 Jul 10.
- Results publication: PubMed 31003194Ismayilova L, Terlikbayeva A, Rozental Y. Computerized intervention to prevent drug use among at-risk adolescents in Central Asia: Preliminary family-level findings from a pilot mixed methods trial. Int J Drug Policy. 2019 Jun;68:75-85. doi: 10.1016/j.drugpo.2019.03.022. Epub 2019 Apr 16.
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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.
Leyla Ismayilova, PhD principal investigator
University of Chicago School of Social Service Administration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kazakhstani Family Together in people with Drug Use, run by University of Chicago at 1 site in Kazakhstan.
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 6 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 22 May 2019. 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 Kazakhstan. 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?
Change in onset and 30-day alcohol and drug use from baseline to 6 months (time frame: Up to 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01969305, which also lists 2 linked publications.
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 22 May 2019.