Substance-Related DisordersNCT01591239
Home-Based Program to Help Parents of Drug Abusing Adolescents
A study testing Home-Based Intervention and Educational Group in people with Substance-Related Disorders and Drug Addiction, run by Treatment Research Institute at 1 site in United States.
Trial summary
This project is aimed at parents with a teenager who is already starting to use drugs. The study will test a new, innovative version of a brief intervention. This program will be home based rather than implemented by a counselor in a clinical setting. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders, Drug Addiction, Substance Abuse
- What is being tested?
- Home-Based Intervention and Educational Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Apr 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 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Referral of the adolescent to the Minneapolis metro area participating sites.
- Both the parent and teen consent to participate.
Who cannot join
- Current developmental disorder or learning disorder.
- current or past history of psychosis, or any psychiatric or other condition that may interfere with ongoing participation in the intervention.
- Suicidal ideation or otherwise judged to be at risk to self or others
- Unstable or uncontrolled medical illnesses which may interfere with participation in the study.
- Inability to understand the study procedures or otherwise give informed assent for participation.
- Failure by the parent to give informed consent for the adolescent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical School, Department of Psychiatry
Minneapolis, Minnesota, 55454
About this study
Official title: Parents as Interventionists for Moderate Drug Abusing Adolescents
This project is aimed at parents with a teenager who is already starting to use drugs. The study will test a new, innovative version of a brief intervention. This program will be home based rather than implemented by a counselor in a clinical setting. The stage I activities will involve manual development, parent training development, and a small feasibility study; Stage II involves an efficacy study. Two samples, 110 families each, will participate in the trial. Families will be assigned to either an intervention or control condition. The investigators hypothesize that the home-based intervention will be superior to the control condition. In addition, the investigators expect response to the intervention by the adolescent to be mediated by motivation, cognitions, problem solving, peer drug use, parenting skills and parent self-efficacy.
Read the detailed description
Little attention has been paid to the large group of adolescents who use substances but are not, or not yet, dependent and who could successfully reduce substance use through early intervention. Brief interventions (BI) that are based in cognitive-behavioral and motivational interviewing (CB-MI) strategies provide an option for such mid-level drug abusers (e.g., DSM-IV substance abuse disorder), and extant research on them suggests this approach can be effective with youth.
Winters and colleagues have studied with controlled designs the efficacy of brief interventions for application to mild-to-moderate substance abusing adolescents. These studies have used the more traditional approach of counselor-led interventions. This program will be parent-led rather than directed by a counselor in a clinical setting.
The stage I activities will involve manual development, parent training development, and a small feasibility study; Stage II involves an efficacy trial. Two samples, 110 families each, will participate in the trial. Families will be assigned to either an intervention or control condition. Data to quantify intervention effects will be obtained by interviewing adolescents and the target parent at multiple time points (baseline and, 3-, 6- and 12-months post baseline). The investigators hypothesize that the home-based intervention will be superior to the control condition. In addition, the investigators expect response to the intervention by the adolescent to be mediated by motivation, cognitions, problem solving, peer drug use, parenting skills and parent self-efficacy. Secondary analyses will focus on additional predictors of intervention effects, and analyses of parent adherence, parent acceptance, and of training adherence.
The final product of the work will be a tested comparative intervention protocol that is shaped in an engaging and useful presentation format for use by parents.
- Conditions
- Substance-Related Disorders, Drug Addiction, Substance Abuse
- Being tested
- Home-Based Intervention, Educational Group
- Keywords
- Adolescent, Parent, Substance Abuse, Parent Training, Addiction, Family Intervention, Brief Intervention, Home Intervention
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based InterventionBehavioural
Parents will be trained through a 3 1/2-hour series on providing a 3-session drug and alcohol intervention program to their adolescent. The parent-led intervention will require parents to meet with their adolescent and work together to help strengthen family cohesiveness, enhance communication, and promote healthy life choices.
Educational GroupBehavioural
Printed fact sheets will be delivered to parents in a single two-hour session. These fact sheets will provide general drug-related information from the public domain (e.g., substance use trends and well-known dangers of substance involvement), and focus on communication approaches and talking points when discussing substance use with their adolescent (e.g., why adolescents use; how the media may influence attitudes about substances).
| Study group | Role | What they receive |
|---|---|---|
| Home-Based Intervention | Experimental | Parents will receive a 1-session training on how to deliver a 3-session intervention across a 3-week period. The intervention program begins with a 3 and a half hour training session delivered by the staff Trainer to the participating parent. At the conclusion of training, the parent will be given the intervention manual and supplemental materials. The trainer will phone the parent shortly before session 1, in between each intervention session, and after the third intervention (four phone calls total) to review the objectives and tasks associated with that week's intervention session and to help prepare for the coming session. At the final phone call between the parent and trainer (after the third week), the trainer will deliver to the parent the follow-up resources. Receives: Behavioral: Home-Based Intervention |
| Educational Group | Active comparator | Parents will receive a 2-hour, education-only psychoeducational curriculum (no parent-led intervention with their teen will occur. Receives: Behavioral: Educational Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent Substance Use
Adolescent participants will complete the Timeline Follow Back in order to assess days of drug use.
Measured: Changes from Baseline at 3-, 6-, and 12- months post-baseline
Adolescent Drug Use Consequences
The adolescent participant will complete the Personal Consequences Scale in order to measure their drug use consequences.
Measured: Changes from Baseline at 3-, 6-, and 12- months post-baseline
DSM-IV Substance Use Diagnosis
The Adolescent Diagnostic Interview (ADI) will be used to determine a diagnosis.
Measured: Changes from Baseline at 3-, 6-, and 12- months post-baseline
Secondary outcomes (5)
Adolescent Mental Health
Adolescent mental health will be measured in two ways. The parent participant will complete the ADI-Parent version and the adolescent participant will complete the Comprehensive Adolescent Severity Inventory (CASI).
Measured: Baseline and 3-, 6-, and 12- months post-baseline
Adolescent Treatment History
Parent participants will provide this data when completing the ADI-Parent version.
Measured: Baseline and 3-, 6-, and 12- months post-baseline
Program Acceptability
The Credibility/Expectancy Questionnaire (CEQ) will be completed by parents during the training session and the Working Alliance Inventory (WAI) will be completed my the parent after he or she completes the third training session with the adolescent.
Measured: Parent Training (average of 2 weeks post-baseline) and Post-Session 3 (average of 6 weeks after the parent training)
Program Satisfaction
Parents will complete a satisfaction questionnaire after completing the third session with the adolescent participant.
Measured: Post-Session 3 (average of 6 weeks after the parent training)
Training Fidelity
A training fidelity checklist will be completed by an assessor following the training.
Measured: Parent Training (average of 2 weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startSep 2011
- Primary completionApr 2016
- Study completionApr 2016
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-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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Treatment Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Ken Winters, Ph.D., Principal investigator, Treatment Research Institute and University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591239
- Sponsor's protocol ID
- P50DA027841
- Other IDs
- P50DA027841
- Status last verified
- Mar 2023
- First submitted
- 7 Apr 2012
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Botzet AM, Dittel C, Birkeland R, Lee S, Grabowski J, Winters KC. Parents as interventionists: Addressing adolescent substance use. J Subst Abuse Treat. 2019 Apr;99:124-133. doi: 10.1016/j.jsat.2019.01.015. Epub 2019 Jan 23.
PubMed 30797384
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents as Interventionists for Moderate Drug Abusing Adolescents
- ClinicalTrials.gov ID
- NCT01591239
- Acronym / sponsor ID
- P50DA027841
- Conditions
- Substance-Related Disorders, Drug Addiction, Substance Abuse
- Keywords
- Adolescent, Parent, Substance Abuse, Parent Training, Addiction, Family Intervention, Brief Intervention, Home Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Treatment Research InstituteUniversity, hospital or other
- Collaborators
- University of Minnesota, National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 May 2012 (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 project is aimed at parents with a teenager who is already starting to use drugs. The study will test a new, innovative version of a brief intervention. This program will be home based rather than implemented by a counselor in a clinical setting. The stage I activities will involve manual development, parent training development, and a small feasibility study; Stage II involves an efficacy study. Two samples, 110 families each, will participate in the trial. Families will be assigned to either an intervention or control condition. The investigators hypothesize that the home-based intervention will be superior to the control condition. In addition, the investigators expect response to the intervention by the adolescent to be mediated by motivation, cognitions, problem solving, peer drug use, parenting skills and parent self-efficacy.
Detailed description
Little attention has been paid to the large group of adolescents who use substances but are not, or not yet, dependent and who could successfully reduce substance use through early intervention. Brief interventions (BI) that are based in cognitive-behavioral and motivational interviewing (CB-MI) strategies provide an option for such mid-level drug abusers (e.g., DSM-IV substance abuse disorder), and extant research on them suggests this approach can be effective with youth.
Winters and colleagues have studied with controlled designs the efficacy of brief interventions for application to mild-to-moderate substance abusing adolescents. These studies have used the more traditional approach of counselor-led interventions. This program will be parent-led rather than directed by a counselor in a clinical setting.
The stage I activities will involve manual development, parent training development, and a small feasibility study; Stage II involves an efficacy trial. Two samples, 110 families each, will participate in the trial. Families will be assigned to either an intervention or control condition. Data to quantify intervention effects will be obtained by interviewing adolescents and the target parent at multiple time points (baseline and, 3-, 6- and 12-months post baseline). The investigators hypothesize that the home-based intervention will be superior to the control condition. In addition, the investigators expect response to the intervention by the adolescent to be mediated by motivation, cognitions, problem solving, peer drug use, parenting skills and parent self-efficacy. Secondary analyses will focus on additional predictors of intervention effects, and analyses of parent adherence, parent acceptance, and of training adherence.
The final product of the work will be a tested comparative intervention protocol that is shaped in an engaging and useful presentation format for use by parents.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-Based Intervention | Experimental | Behavioral: Home-Based InterventionParents will receive a 1-session training on how to deliver a 3-session intervention across a 3-week period. The intervention program begins with a 3 and a half hour training session delivered by the staff Trainer to the participating parent. At the conclusion of training, the parent will be given the intervention manual and supplemental materials. The trainer will phone the parent shortly before session 1, in between each intervention session, and after the third intervention (four phone calls total) to review the objectives and tasks associated with that week's intervention session and to help prepare for the coming session. At the final phone call between the parent and trainer (after the third week), the trainer will deliver to the parent the follow-up resources. |
| Educational Group | Active comparator | Behavioral: Educational GroupParents will receive a 2-hour, education-only psychoeducational curriculum (no parent-led intervention with their teen will occur. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Referral of the adolescent to the Minneapolis metro area participating sites.
- Both the parent and teen consent to participate.
Key exclusion criteria (6 listed)
- Current developmental disorder or learning disorder.
- current or past history of psychosis, or any psychiatric or other condition that may interfere with ongoing participation in the intervention.
- Suicidal ideation or otherwise judged to be at risk to self or others
- Unstable or uncontrolled medical illnesses which may interfere with participation in the study.
- Inability to understand the study procedures or otherwise give informed assent for participation.
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 |
|---|---|---|
| Home-Based InterventionParents will be trained through a 3 1/2-hour series on providing a 3-session drug and alcohol intervention program to their adolescent. The parent-led intervention will require parents to meet with their adolescent and work together to help strengthen family cohesiveness, enhance communication, and promote healthy life choices. | Behavioural | Home-Based Intervention |
| Educational GroupPrinted fact sheets will be delivered to parents in a single two-hour session. These fact sheets will provide general drug-related information from the public domain (e.g., substance use trends and well-known dangers of substance involvement), and focus on communication approaches and talking points when discussing substance use with their adolescent (e.g., why adolescents use; how the media may influence attitudes about substances). | Behavioural | Educational Group |
Primary outcome
Adolescent Substance Use
Time frame: Changes from Baseline at 3-, 6-, and 12- months post-baseline
Adolescent participants will complete the Timeline Follow Back in order to assess days of drug use.
Adolescent Drug Use Consequences
Time frame: Changes from Baseline at 3-, 6-, and 12- months post-baseline
The adolescent participant will complete the Personal Consequences Scale in order to measure their drug use consequences.
DSM-IV Substance Use Diagnosis
Time frame: Changes from Baseline at 3-, 6-, and 12- months post-baseline
The Adolescent Diagnostic Interview (ADI) will be used to determine a diagnosis.
5 secondary outcomes
Adolescent Mental Health
Time frame: Baseline and 3-, 6-, and 12- months post-baseline
Adolescent Treatment History
Time frame: Baseline and 3-, 6-, and 12- months post-baseline
Program Acceptability
Time frame: Parent Training (average of 2 weeks post-baseline) and Post-Session 3 (average of 6 weeks after the parent training)
Program Satisfaction
Time frame: Post-Session 3 (average of 6 weeks after the parent training)
Training Fidelity
Time frame: Parent Training (average of 2 weeks post-baseline)
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 28 Mar 2023.
- Derived from this study: PubMed 30797384Botzet AM, Dittel C, Birkeland R, Lee S, Grabowski J, Winters KC. Parents as interventionists: Addressing adolescent substance use. J Subst Abuse Treat. 2019 Apr;99:124-133. doi: 10.1016/j.jsat.2019.01.015. Epub 2019 Jan 23.
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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.
Ken Winters, Ph.D. principal investigator
Treatment Research Institute and University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-Based Intervention and Educational Group in people with Substance-Related Disorders and Drug Addiction, run by Treatment Research Institute 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 2 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 28 Mar 2023. 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?
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?
Adolescent Substance Use (time frame: Changes from Baseline at 3-, 6-, and 12- months post-baseline). The study lists 3 primary outcomes in all. 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 NCT01591239, 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 28 Mar 2023.