Substance-Related DisordersNCT00957775
Computer-delivered Psychosocial Intervention for Adolescent Substance Use Disorders
A study testing Computer-delivered ACRA in people with Substance-Related Disorders and Alcohol-Related Disorders, run by National Development and Research Institutes, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to develop and evaluate the acceptability and preliminary efficacy of a web-based, skills training program for adolescents with substance use disorders. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Substance-Related Disorders, Alcohol-Related Disorders, Marijuana Abuse
- What is being tested?
- Computer-delivered ACRA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jul 2011
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of non-nicotine alcohol or drug use disorder
- English speaking
- Parental consent to participate for adolescents under the age of 18.
Who cannot join
- Clinical diagnosis of psychiatric disorders that require intensive level of services, such as active psychosis, active mania or active suicidality
- Plan to move out of the area within the next 3 months
- Insufficient ability to understand and provide informed consent/assent to participate
- Lack sufficient ability to use English to participate in the consent/assent process, the interventions or assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
National Development and Research Institutes, Inc.; St. Luke's-Roosevelt Hospital Center
New York, New York, 10010; 10025
Ramon Solhkhah, MD
About this study
The purpose of this study is to develop and evaluate the acceptability and preliminary efficacy of a web-based, skills training program for adolescents with substance use disorders.
Read the detailed description
Substance use among youth remains a major public health problem. About half of all 12th graders have tried an illicit drug and over 72% of this same age group have used alcohol. Rates of abuse of prescription opioids among youth are estimated to have increased about 542% in the past decade. Although effective substance abuse treatment programs for youth exist, they are currently of limited reach. Only 1 in 10 adolescents who need substance abuse treatment receive any care. An interactive, computer-delivered psychosocial (skills-training) intervention has the potential to address these challenges, as it allows for complex interventions to be delivered at a low cost, without increasing demands on staff time or training needs. It may also be highly acceptable to youth and enable widespread dissemination of science-based treatment in a manner that ensures fidelity.
In this project, we plan to develop and evaluate the acceptability and preliminary efficacy of a web-based, skills training program for adolescents with substance use disorders. The content of this program will be based in a model of psychosocial substance abuse treatment for youth that has been shown to be effective in prior scientific research. It will be provided via an interactive, delivery system that employs informational technologies that are effective in promoting relevant knowledge and skills. Adolescents in substance abuse treatment will help shape the development of this program. To our knowledge, the planned program will be the first interactive program to provide comprehensive, psychosocial substance abuse treatment to adolescents via computer-based technology.
This research will contribute new information relevant to increasing the delivery of science-based psychosocial treatment to adolescents with substance use disorders in a manner that is cost-effective and which may promote the adoption of effective treatment.
- Being tested
- Usual care, Computer-delivered ACRA
- Keywords
- Substance Abuse Treatment, Adolescents, Substance-Related Disorders, Alcohol-Related Disorders, Marijuana Abuse
- Medical subject headings
- Substance-Related Disorders, Alcohol-Related Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careBehavioural
Also called treatment-as-usual (TAU)
Participants will receive the usual care (e.g., individual therapy, group therapy, family therapy, self-help groups) provided at the treatment site.
Computer-delivered ACRABehavioural
Participants and willing caregivers will receive a computer-delivered intervention for 12 weeks, based on the Adolescent Community Reinforcement Approach to substance abuse treatment.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Participants will receive the usual care (e.g., individual therapy, group therapy, self-help groups) provided at the treatment site. Receives: Behavioral: Usual care |
| Computer-delivered ACRA | Experimental | Participants and willing caregivers will receive a computer-delivered intervention for 12 weeks, based on the Adolescent Community Reinforcement Approach to substance abuse treatment. Receives: Behavioral: Computer-delivered ACRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
substance use
Measured: 16 weeks
acceptability of intervention
Measured: 12 weeks
Secondary outcomes (2)
HIV risk behavior
Measured: 16 weeks
psychosocial functioning
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Development and Research Institutes, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- St. Luke's-Roosevelt Hospital Center
- Investigators
- Lisa Marsch, Ph.D., Principal investigator, National Development and Research Institutes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957775
- Sponsor's protocol ID
- R01DA025072
- Other IDs
- R01DA025072
- Status last verified
- Aug 2009
- First submitted
- 11 Aug 2009
- Last updated
- 12 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-delivered Psychosocial Intervention for Adolescent Substance Use Disorders
- ClinicalTrials.gov ID
- NCT00957775
- Acronym / sponsor ID
- R01DA025072
- Keywords
- Substance Abuse Treatment, Adolescents, Substance-Related Disorders, Alcohol-Related Disorders, Marijuana Abuse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- National Development and Research Institutes, Inc.University, hospital or other
- Collaborators
- St. Luke's-Roosevelt Hospital Center
- Study start
- Aug 2009
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 12 Aug 2009 (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 study is to develop and evaluate the acceptability and preliminary efficacy of a web-based, skills training program for adolescents with substance use disorders.
Detailed description
Substance use among youth remains a major public health problem. About half of all 12th graders have tried an illicit drug and over 72% of this same age group have used alcohol. Rates of abuse of prescription opioids among youth are estimated to have increased about 542% in the past decade. Although effective substance abuse treatment programs for youth exist, they are currently of limited reach. Only 1 in 10 adolescents who need substance abuse treatment receive any care. An interactive, computer-delivered psychosocial (skills-training) intervention has the potential to address these challenges, as it allows for complex interventions to be delivered at a low cost, without increasing demands on staff time or training needs. It may also be highly acceptable to youth and enable widespread dissemination of science-based treatment in a manner that ensures fidelity.
In this project, we plan to develop and evaluate the acceptability and preliminary efficacy of a web-based, skills training program for adolescents with substance use disorders. The content of this program will be based in a model of psychosocial substance abuse treatment for youth that has been shown to be effective in prior scientific research. It will be provided via an interactive, delivery system that employs informational technologies that are effective in promoting relevant knowledge and skills. Adolescents in substance abuse treatment will help shape the development of this program. To our knowledge, the planned program will be the first interactive program to provide comprehensive, psychosocial substance abuse treatment to adolescents via computer-based technology.
This research will contribute new information relevant to increasing the delivery of science-based psychosocial treatment to adolescents with substance use disorders in a manner that is cost-effective and which may promote the adoption of effective treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Behavioral: Usual careParticipants will receive the usual care (e.g., individual therapy, group therapy, self-help groups) provided at the treatment site. |
| Computer-delivered ACRA | Experimental | Behavioral: Computer-delivered ACRAParticipants and willing caregivers will receive a computer-delivered intervention for 12 weeks, based on the Adolescent Community Reinforcement Approach to substance abuse treatment. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of non-nicotine alcohol or drug use disorder
- English speaking
- Parental consent to participate for adolescents under the age of 18.
Key exclusion criteria (4 listed)
- Clinical diagnosis of psychiatric disorders that require intensive level of services, such as active psychosis, active mania or active suicidality
- Plan to move out of the area within the next 3 months
- Insufficient ability to understand and provide informed consent/assent to participate
- Lack sufficient ability to use English to participate in the consent/assent process, the interventions or assessments
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 |
|---|---|---|
| Usual careAlso: treatment-as-usual (TAU)Participants will receive the usual care (e.g., individual therapy, group therapy, family therapy, self-help groups) provided at the treatment site. | Behavioural | Usual care |
| Computer-delivered ACRAParticipants and willing caregivers will receive a computer-delivered intervention for 12 weeks, based on the Adolescent Community Reinforcement Approach to substance abuse treatment. | Behavioural | Computer-delivered ACRA |
Primary outcome
substance use
Time frame: 16 weeks
acceptability of intervention
Time frame: 12 weeks
2 secondary outcomes
HIV risk behavior
Time frame: 16 weeks
psychosocial functioning
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2009.
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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.
Lisa Marsch, Ph.D. principal investigator
National Development and Research Institutes, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-delivered ACRA in people with Substance-Related Disorders and Alcohol-Related Disorders, run by National Development and Research Institutes, Inc. 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 4 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 12 Aug 2009. 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. 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 Michelle Acosta, Ph.D. (212-845-4535, acosta@ndri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
substance use (time frame: 16 weeks). The study lists 2 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 12 Aug 2009.