Substance UseTWCNCT03642106
Unidos Against ATOD Use Intervention Trial
A study testing Unidos Se Puede in people with Substance Use, run by Oklahoma State University at 1 site in United States.
Trial summary
Adolescent alcohol tobacco and drug (ATOD) use is a major public health concern, with rates for Latino middle school youth higher than other ethnic groups. One well-established precursor of adolescent ATOD use is psychosocial stress. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- Unidos Se Puede
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 31 Aug 2023
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Self-identified as Latino (Hispanic),
- Spanish as the primary language spoken in home,
- Enrolled in 6th or 7th grade in public school at one of the target sites.
Who cannot join
- Currently undergoing mental health treatment,
- Not eligible to take end of year examinations due to cognitive limitations.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Oklahoma State University-Tulsa
Tulsa, Oklahoma, 74106
Ronald B Cox, PhD, 405-744-9938, r.cox@okstate.edu
Isaac Washburn, PhD, 4057443683, isaac.washburn@okstate.edu
About this study
Official title: Reducing Alcohol, Tobacco, and Drug Use Among Latino Immigrant Youth: A Preliminary Test of the ¡Unidos Se Puede! Program
Adolescent alcohol tobacco and drug (ATOD) use is a major public health concern, with rates for Latino middle school youth higher than other ethnic groups. One well-established precursor of adolescent ATOD use is psychosocial stress. The proposed project examines the preliminary efficacy of Unidos to decrease ATOD use among Latino youth in new settlement areas. The goals of this efficacy trial will be achieved by accomplishing two specific aims: (1) Evaluate the potential of the intervention to delay the initiation into or reduce ATOD use among Latino youth who are 1st to 2nd generation immigrants; and (2) Evaluate the intervention's ability to strengthen known protective factors against ATOD use among adolescents-specifically child personal agency and parent-child, peer, and school relationships.
The study's primary hypothesis is: The Unidos Se Puede program will delay initiation of ATOD use of current non-users and reduce use among current users.
Read the detailed description
Adolescent alcohol tobacco and drug (ATOD) use is a major public health concern, with rates for Latino middle school youth higher than other ethnic groups. One well-established precursor of adolescent ATOD use is psychosocial stress. The overall aim of this project is to test the efficacy of a culturally appropriate psychosocial program to prevent or reduce ATOD use among Latino immigrant youth. The intervention consists of: (1) encouraging parental involvement in child schooling, general parenting skills, and coping strategies ; (2) fostering child social emotional learning (SEL) through assigning a near-peer success coach to help develop critical thinking, problem solving, and goal setting skills; and (3) promoting positive peer affiliations through participation in regular activities that facilitate bonding to prosocial institutions.
The specific aims are:
(1) Evaluate the potential of the intervention to delay the initiation into or reduce ATOD use among Latino youth who are 1st to 2nd generation immigrants; and (2) Evaluate the intervention's ability to strengthen known protective factors against ATOD use among adolescents-specifically child personal agency and parent-child, peer, and school relationships.
The study's primary hypothesis is: The Unidos Se Puede program will delay initiation of ATOD use of current non-users and reduce use among current users.
To accomplish these aims, we propose an attention placebo randomized control trial. For this trial, we will recruit a sample of youth and their parents (N=120 dyads) from a random sample of Latino 6th and 7th grade students in Tulsa Public Schools. Those meeting the inclusion/exclusion criteria and agreeing to participate will provide baseline data before being randomly assigned to either the treatment or control condition (n=60 dyads each). Participants will be followed for 12 months post-baseline, during which time we will collect psychosocial measures annually near the end of each school year (May to June). The study will collect psychosocial measures from parents and youth.
- Conditions
- Substance Use
- Being tested
- Unidos Se Puede
- Keywords
- Adolescent, Latino, Immigrant
- 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.
Unidos Se PuedeBehavioural
Also called UWC
The intervention consists of: (1) encouraging parental involvement in child schooling, general parenting skills, and coping strategies ; (2) fostering child social emotional learning (SEL) through assigning a near-peer success coach to help develop critical thinking, problem solving, and goal setting skills; and (3) promoting positive peer affiliations through participation in regular activities that facilitate bonding to prosocial institutions.
| Study group | Role | What they receive |
|---|---|---|
| Unidos Se Puede | Active comparator | Unidos Se Puede: consists of 5-weekly Family Workshops, 6 monthly booster sessions, 10-months success coaching, adolescent group activities and will be compared to an attention placebo control. Receives: Behavioral: Unidos Se Puede |
| Attention placebo control | Placebo comparator | Placebo consists of after school club for youth. Receives: Behavioral: Unidos Se Puede |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in past 30-day ATOD use (alcohol, tobacco, marijuana)
The ATOD outcome measure creates a single index of use by summing youth report of the frequency of their use during the past 30 days for each of the following substance: alcohol, tobacco and marijuana.
Measured: Baseline and 12 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Jan 2020
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To accomplish the mentioned aims, we propose an attention placebo randomized control trial. For this trial, we will recruit a sample of youth and their parents (N=120 dyads) from a random sample of Latino 6th and 7th grade students in Tulsa Public Schools. Those meeting the inclusion/exclusion criteria and agreeing to participate will provide baseline data before being randomly assigned to either the treatment or control condition (n=60 dyads each). Participants will be followed for 12 months post-baseline, during which time we will collect psychosocial measures annually near the end of each school year (May to June). The study will collect psychosocial measures from parents and youth.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Ronald Cox, Oklahoma State University
- Investigators
- Ronald B Cox, PhD, Principal investigator, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642106
- Sponsor's protocol ID
- IRB-21-290
- Other IDs
- 5P20GM109097-02, 1R15DA049232-01
- Acronym
- TWC
- Status last verified
- Jul 2022
- First submitted
- 13 Apr 2018
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The intent to share data with other researchers exists, however, a plan to do so has not yet been developed.
Publications
Cox RB, Washburn I, Greder K, Sahbaz S, Lin H. Preventing substance use among Latino youth: Initial results from a multistate family-based program focused on youth academic success. Am J Drug Alcohol Abuse. 2022 Jan 2;48(1):69-77. doi: 10.1080/00952990.2021.1981357. Epub 2021 Oct 28.
PubMed 34710334
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Alcohol, Tobacco, and Drug Use Among Latino Immigrant Youth: A Preliminary Test of the ¡Unidos Se Puede! Program
- ClinicalTrials.gov ID
- NCT03642106
- Acronym / sponsor ID
- TWC / IRB-21-290
- Conditions
- Substance Use
- Keywords
- Adolescent, Latino, Immigrant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 22 Aug 2018 (actual)
- 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.
Adolescent alcohol tobacco and drug (ATOD) use is a major public health concern, with rates for Latino middle school youth higher than other ethnic groups. One well-established precursor of adolescent ATOD use is psychosocial stress. The proposed project examines the preliminary efficacy of Unidos to decrease ATOD use among Latino youth in new settlement areas. The goals of this efficacy trial will be achieved by accomplishing two specific aims: (1) Evaluate the potential of the intervention to delay the initiation into or reduce ATOD use among Latino youth who are 1st to 2nd generation immigrants; and (2) Evaluate the intervention's ability to strengthen known protective factors against ATOD use among adolescents-specifically child personal agency and parent-child, peer, and school relationships.
The study's primary hypothesis is: The Unidos Se Puede program will delay initiation of ATOD use of current non-users and reduce use among current users.
Detailed description
Adolescent alcohol tobacco and drug (ATOD) use is a major public health concern, with rates for Latino middle school youth higher than other ethnic groups. One well-established precursor of adolescent ATOD use is psychosocial stress. The overall aim of this project is to test the efficacy of a culturally appropriate psychosocial program to prevent or reduce ATOD use among Latino immigrant youth. The intervention consists of: (1) encouraging parental involvement in child schooling, general parenting skills, and coping strategies ; (2) fostering child social emotional learning (SEL) through assigning a near-peer success coach to help develop critical thinking, problem solving, and goal setting skills; and (3) promoting positive peer affiliations through participation in regular activities that facilitate bonding to prosocial institutions.
The specific aims are:
(1) Evaluate the potential of the intervention to delay the initiation into or reduce ATOD use among Latino youth who are 1st to 2nd generation immigrants; and (2) Evaluate the intervention's ability to strengthen known protective factors against ATOD use among adolescents-specifically child personal agency and parent-child, peer, and school relationships.
The study's primary hypothesis is: The Unidos Se Puede program will delay initiation of ATOD use of current non-users and reduce use among current users.
To accomplish these aims, we propose an attention placebo randomized control trial. For this trial, we will recruit a sample of youth and their parents (N=120 dyads) from a random sample of Latino 6th and 7th grade students in Tulsa Public Schools. Those meeting the inclusion/exclusion criteria and agreeing to participate will provide baseline data before being randomly assigned to either the treatment or control condition (n=60 dyads each). Participants will be followed for 12 months post-baseline, during which time we will collect psychosocial measures annually near the end of each school year (May to June). The study will collect psychosocial measures from parents and youth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To accomplish the mentioned aims, we propose an attention placebo randomized control trial. For this trial, we will recruit a sample of youth and their parents (N=120 dyads) from a random sample of Latino 6th and 7th grade students in Tulsa Public Schools. Those meeting the inclusion/exclusion criteria and agreeing to participate will provide baseline data before being randomly assigned to either the treatment or control condition (n=60 dyads each). Participants will be followed for 12 months post-baseline, during which time we will collect psychosocial measures annually near the end of each school year (May to June). The study will collect psychosocial measures from parents and youth.
| Arm | Type | Receives |
|---|---|---|
| Unidos Se Puede | Active comparator | Behavioral: Unidos Se PuedeUnidos Se Puede: consists of 5-weekly Family Workshops, 6 monthly booster sessions, 10-months success coaching, adolescent group activities and will be compared to an attention placebo control. |
| Attention placebo control | Placebo comparator | Behavioral: Unidos Se PuedePlacebo consists of after school club for youth. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Self-identified as Latino (Hispanic),
- Spanish as the primary language spoken in home,
- Enrolled in 6th or 7th grade in public school at one of the target sites.
Key exclusion criteria (2 listed)
- Currently undergoing mental health treatment,
- Not eligible to take end of year examinations due to cognitive limitations.
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 |
|---|---|---|
| Unidos Se PuedeAlso: UWCThe intervention consists of: (1) encouraging parental involvement in child schooling, general parenting skills, and coping strategies ; (2) fostering child social emotional learning (SEL) through assigning a near-peer success coach to help develop critical thinking, problem solving, and goal setting skills; and (3) promoting positive peer affiliations through participation in regular activities that facilitate bonding to prosocial institutions. | Behavioural | Attention placebo control, Unidos Se Puede |
Primary outcome
Change in past 30-day ATOD use (alcohol, tobacco, marijuana)
Time frame: Baseline and 12 months post-baseline
The ATOD outcome measure creates a single index of use by summing youth report of the frequency of their use during the past 30 days for each of the following substance: alcohol, tobacco and marijuana.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Derived from this study: PubMed 34710334Cox RB, Washburn I, Greder K, Sahbaz S, Lin H. Preventing substance use among Latino youth: Initial results from a multistate family-based program focused on youth academic success. Am J Drug Alcohol Abuse. 2022 Jan 2;48(1):69-77. doi: 10.1080/00952990.2021.1981357. Epub 2021 Oct 28.
- Individual participant dataSharing planned: Undecided. The intent to share data with other researchers exists, however, a plan to do so has not yet been developed.
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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.
Ronald B Cox, PhD principal investigator
Oklahoma State 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 Unidos Se Puede in people with Substance Use, run by Oklahoma State University at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 27 Jul 2022. 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 United States. 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. Some participants in this study may receive a placebo. 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 Ronald B Cox, PhD (4057449938, r.cox@okstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in past 30-day ATOD use (alcohol, tobacco, marijuana) (time frame: Baseline and 12 months post-baseline). 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 NCT03642106, which also lists 1 linked publication.
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 27 Jul 2022.