Alcohol AbusePhase 1NCT00925340
Family Check-Up for Adolescents and Siblings
A Phase 1 study testing Family Check Up and Psychoeducation in people with Alcohol Abuse, run by Brown University at 1 site in United States.
Trial summary
A two group randomized design will be used to test the primary hypothesis that the experimental intervention will reduce alcohol consumption and alcohol-related negative consequences significantly more than a comparison family-based psychoeducation condition in both an identified alcohol-using adolescent (12- 18 years… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Family Check Up and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jul 2014
- Phase
- Phase 1
- 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
- Participants will be 12 to 18 years old, inclusive, living at home with at least one parent or guardian.
- Participants will have a teenage sibling within 3 years of age of the identified adolescent patient. Siblings can be either biological or unrelated siblings in blended families, as long as they live in the same home as the parents targeted in the intervention conditions. The adolescent must have experienced a recent (within 1 month) alcohol-related event (ED admission, school disciplinary action, grounding by parents, legal action). The adolescent must also screen in by reaching the clinical cutoff score on the Adolescent Drinking Index.
Who cannot join
- Alcohol positive adolescents with substance dependence diagnosis requiring a higher level of care; 18 year olds living on their own.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Family Check-Up on Adolescents With Alcohol-Related Events and Their Siblings
A two group randomized design will be used to test the primary hypothesis that the experimental intervention will reduce alcohol consumption and alcohol-related negative consequences significantly more than a comparison family-based psychoeducation condition in both an identified alcohol-using adolescent (12- 18 years old) and his/her teenage sibling (the sibling can be 3 years older or younger than teen with the sibling's age between 12-21 years old). The experimental condition consists of the Family Check-up, while the comparison condition is a less intense parenting psychoeducation program. Time points will include follow-ups at 3, 6, and 12 months.
Read the detailed description
A total of 175 adolescents, 12 to 18 years old, will be drawn from multiple sites to compare the experimental condition, The Family Check Up(FCU; Dishion \& Kavanagh, 2003) to a family-based psychoeducational program.
The Family Check-Up is a selective intervention program that focuses on parents. Its goal is to provide individualized feedback to motivate parents to make improvements in their parenting practices. A unique strength of the FCU is that feedback is individualized and tailored to specific parenting skills as they typically pertain to an identified adolescent in the family. We propose to evaluate the efficacy of the FCU when applied to both an adolescent identified patient (IP) and a sibling close in age. Our rationale for including a sibling close in age derives from a strong empirical base which has shown that: 1) sibling resemblance for alcohol use is high and environmental factors shared by siblings account for substantial portions of variance in adolescent alcohol use; and 2) specific interactional dynamics of the sibling relationship (collusion) are related to teen alcohol use. Dr. Dishion has found that in high-risk families, sibling collusion accounts for variance in problem behavior after controlling for involvement with deviant peers. This connection between ineffective parenting strategies and sibling relationship dynamics in combination creates increased risk for alcohol use by siblings close in age. This notion serves as a foundation to examine the efficacy of a sibling-enhanced FCU intervention with respect to: 1) improvement in parental communication and monitoring; 2) reduction of sibling interactive behaviors that are associated with alcohol use; and 3) reduction of alcohol use in IP adolescents as well as siblings who are currently using alcohol. We will test specified mediators of FCU efficacy in reducing levels of alcohol use at both the parenting level and at the level of sibling dynamics. In order to determine whether other types of family-based interventions might be just as helpful as the more intensive FCU, efficacy of the sibling-enhanced FCU will be compared to a parenting psychoeducational program.
- Conditions
- Alcohol Abuse
- Being tested
- Family Check Up, Psychoeducation
- Keywords
- Alcohol, Substance Abuse, Adolescent, Family functioning
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Check UpBehavioural
The Family Check-Up provides a thorough assessment of individual family strengths and weaknesses and utilizes principles of motivational interviewing to encourage families to change.
PsychoeducationBehavioural
Psychoeducation regarding teen alcohol and drug use in general, along with ways parents can help their children stay safe from using alcohol or drugs.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Family Check Up | Experimental | Brief family intervention that employs Motivational Interviewing. Receives: Behavioral: Family Check Up |
| 2 - Psychoeducation | Active comparator | Not described Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Teen and sibling alcohol use
drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion)
Measured: 3 months
Teen and sibling alcohol use
drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion
Measured: 6 months
Teen and sibling alcohol use
drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion
Measured: 12 months
Secondary outcomes (3)
Teen and sibling marijuana use
Days of marijuana use in prior 3 months
Measured: 3 months
Teen and sibling marijuana use
Days of use in prior 3 months
Measured: 6 months
Teen and siblings marijuana use
Days of use in prior 3 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startSep 2008
- Primary completionJul 2014
- Study completionJul 2014
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 Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Anthony Spirito, Brown University
- Investigators
- Anthony Spirito, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925340
- Sponsor's protocol ID
- NIAAA-Spirito-AA017659
- Other IDs
- R01AA017659, NIH Grant 1R01 AA017659-01
- Status last verified
- Jul 2014
- First submitted
- 19 Jun 2009
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Spirito A, Hernandez L, Marceau K, Cancilliere MK, Barnett NP, Graves HR, Rodriguez AM, Knopik VS. Effects of a brief, parent-focused intervention for substance using adolescents and their sibling. J Subst Abuse Treat. 2017 Jun;77:156-165. doi: 10.1016/j.jsat.2017.02.002. Epub 2017 Mar 2.
PubMed 28259500
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Family Check-Up on Adolescents With Alcohol-Related Events and Their Siblings
- ClinicalTrials.gov ID
- NCT00925340
- Acronym / sponsor ID
- NIAAA-Spirito-AA017659
- Conditions
- Alcohol Abuse
- Keywords
- Alcohol, Substance Abuse, Adolescent, Family functioning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 Jun 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.
A two group randomized design will be used to test the primary hypothesis that the experimental intervention will reduce alcohol consumption and alcohol-related negative consequences significantly more than a comparison family-based psychoeducation condition in both an identified alcohol-using adolescent (12- 18 years old) and his/her teenage sibling (the sibling can be 3 years older or younger than teen with the sibling's age between 12-21 years old). The experimental condition consists of the Family Check-up, while the comparison condition is a less intense parenting psychoeducation program. Time points will include follow-ups at 3, 6, and 12 months.
Detailed description
A total of 175 adolescents, 12 to 18 years old, will be drawn from multiple sites to compare the experimental condition, The Family Check Up(FCU; Dishion \& Kavanagh, 2003) to a family-based psychoeducational program.
The Family Check-Up is a selective intervention program that focuses on parents. Its goal is to provide individualized feedback to motivate parents to make improvements in their parenting practices. A unique strength of the FCU is that feedback is individualized and tailored to specific parenting skills as they typically pertain to an identified adolescent in the family. We propose to evaluate the efficacy of the FCU when applied to both an adolescent identified patient (IP) and a sibling close in age. Our rationale for including a sibling close in age derives from a strong empirical base which has shown that: 1) sibling resemblance for alcohol use is high and environmental factors shared by siblings account for substantial portions of variance in adolescent alcohol use; and 2) specific interactional dynamics of the sibling relationship (collusion) are related to teen alcohol use. Dr. Dishion has found that in high-risk families, sibling collusion accounts for variance in problem behavior after controlling for involvement with deviant peers. This connection between ineffective parenting strategies and sibling relationship dynamics in combination creates increased risk for alcohol use by siblings close in age. This notion serves as a foundation to examine the efficacy of a sibling-enhanced FCU intervention with respect to: 1) improvement in parental communication and monitoring; 2) reduction of sibling interactive behaviors that are associated with alcohol use; and 3) reduction of alcohol use in IP adolescents as well as siblings who are currently using alcohol. We will test specified mediators of FCU efficacy in reducing levels of alcohol use at both the parenting level and at the level of sibling dynamics. In order to determine whether other types of family-based interventions might be just as helpful as the more intensive FCU, efficacy of the sibling-enhanced FCU will be compared to a parenting psychoeducational program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Family Check Up | Experimental | Behavioral: Family Check UpBrief family intervention that employs Motivational Interviewing. |
| 2 - Psychoeducation | Active comparator | Behavioral: Psychoeducation |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Participants will be 12 to 18 years old, inclusive, living at home with at least one parent or guardian.
- Participants will have a teenage sibling within 3 years of age of the identified adolescent patient. Siblings can be either biological or unrelated siblings in blended families, as long as they live in the same home as the parents targeted in the intervention conditions. The adolescent must have experienced a recent (within 1 month) alcohol-related event (ED admission, school disciplinary action, grounding by parents, legal action). The adolescent must also screen in by reaching the clinical cutoff score on the Adolescent Drinking Index.
Key exclusion criteria (1 listed)
- Alcohol positive adolescents with substance dependence diagnosis requiring a higher level of care; 18 year olds living on their own.
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 |
|---|---|---|
| Family Check UpThe Family Check-Up provides a thorough assessment of individual family strengths and weaknesses and utilizes principles of motivational interviewing to encourage families to change. | Behavioural | 1 - Family Check Up |
| PsychoeducationPsychoeducation regarding teen alcohol and drug use in general, along with ways parents can help their children stay safe from using alcohol or drugs. | Behavioural | 2 - Psychoeducation |
Primary outcome
Teen and sibling alcohol use
Time frame: 3 months
drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion)
Teen and sibling alcohol use
Time frame: 6 months
drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion
Teen and sibling alcohol use
Time frame: 12 months
drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion
3 secondary outcomes
Teen and sibling marijuana use
Time frame: 3 months
Teen and sibling marijuana use
Time frame: 6 months
Teen and siblings marijuana use
Time frame: 12 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 29 Jul 2014.
- Derived from this study: PubMed 28259500Spirito A, Hernandez L, Marceau K, Cancilliere MK, Barnett NP, Graves HR, Rodriguez AM, Knopik VS. Effects of a brief, parent-focused intervention for substance using adolescents and their sibling. J Subst Abuse Treat. 2017 Jun;77:156-165. doi: 10.1016/j.jsat.2017.02.002. Epub 2017 Mar 2.
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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.
Anthony Spirito, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Family Check Up and Psychoeducation in people with Alcohol Abuse, run by Brown 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 2 inclusion and 1 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 29 Jul 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Teen and sibling alcohol use (time frame: 3 months). 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 NCT00925340, 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 29 Jul 2014.