Substance UsePAL-2NCT01490307
A Family Intervention for Adolescent Problem Behavior (AKA Project Alliance 2)
A study testing Family Check-Up in people with Substance Use and Conduct Disorder, run by University of Oregon at 1 site in United States.
Trial summary
The goal of this project is to empirically refine and improve a comprehensive family-centered prevention strategy for reducing and preventing adolescent substance use and other problem behaviors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Substance Use, Conduct Disorder, Depression
- What is being tested?
- Family Check-Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 593 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parents of all sixth grade students across 2 cohorts at 3 public middle schools were invited to participate in this study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oregon-Child and Family Center
Portland, Oregon, 97232
About this study
Official title: A Family Intervention for Adolescent Problem Behavior
The goal of this project is to empirically refine and improve a comprehensive family-centered prevention strategy for reducing and preventing adolescent substance use and other problem behaviors. This project builds on 15 years of programmatic research underlying the development of the Family Check-up model (FCU), originally referred to as the Adolescent Transitions Program (ATP; Dishion \& Kavanagh, 2003), but later expanded as a general approach to mental health treatment for children from ages 2 through 17 (Dishion \& Stormshak, 2007). The FCU model is a multilevel, family-centered strategy delivered within the context of a public school setting that comprehensively links universal, selected, and indicated family interventions. Previous research and the investigators' practical experience working in school settings indicate that the intervention strategy needs improvement in 3 critical areas to build on previous significant effects and to enhance the potential for future dissemination and large-scale implementation:(a) improve the feasibility of both the universal level and the indicated level of the intervention by broadening the intervention components and systematically embedding these components into the current behavioral support systems in the schools; (b) address the transition from middle school to high school, with special attention to academic engagement and reduction of deviant peer clustering; and (c) explicitly incorporate principals of successful interventions with families and young adolescents of diverse ethnic groups into both the universal and indicated models. An additional general goal of this study is to develop, test, and refine a set of research-based instruments that facilitate evaluation, training, implementation, and monitoring of intervention fidelity to maximize the potential success of implementation and large-scale dissemination.
Participants include 593 youth and their families recruited from the 6th grade in three public middle schools in Portland, OR. Families were randomly assigned to receive either the FCU intervention model or treatment as usual. Assessments were collected for 5 years through the 10th grade. High school transition planning and intensive intervention efforts occurred in Grades 7-9.
The investigators tested the hypothesis that the FCU intervention will reduce the growth of problem behavior and substance use through the enhancement of family management and parent involvement in school.
Read the detailed description
Specific aims of the current project are to:
- Establish a Family Resource Center (FRC) that builds on school-wide behavior management;
- Extend the intervention model to explicitly address the high school transition;
- Develop intervention components specifically focused on the cultural enhancement with a broader youth population, and test the efficacy of these interventions for reducing risk and enhancing positive adjustment for youth and their families;
- Evaluate the preventive impact of family engagement on individual differences in the growth of deviant peer involvement, antisocial behavior, and tobacco, alcohol, and marijuana use during the critical transition to high school; and
- Develop a training and fidelity model related to change.
- Conditions
- Substance Use, Conduct Disorder, Depression, Anxiety
- Being tested
- Family Check-Up
- Keywords
- parenting intervention, Family Check-Up, Anxiety Disorders, Depression, Depressive Disorder, Conduct Disorder, Mental Disorders, Behavioral Symptoms, Mood Disorders, Mental Disorders Diagnosed in Childhood, Substance-Related Disorders
- Medical subject headings
- Substance-Related Disorders, Conduct Disorder, Depression, Anxiety Disorders, Depressive Disorder, Mental Disorders, Behavioral Symptoms, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Check-UpBehavioural
Also called Adolescent Transitions Project (ATP), Ecological Family Intervention and Treatment (EcoFIT)
The Family Check-Up starts with a rapport-building session that allows therapists to gauge parents' concerns and motivation for change. This is followed by a thorough assessment of individual family strengths and weaknesses, utilizing parent and child questionnaires and family video observations. Parents then receive feedback on the results of the assessment using motivational interviewing techniques. Attention is focused on parents' and children's readiness to change, as well as the delineation of specific change options. Families may continued to receive tailored intervention services using the Everyday Parenting Curriculum.
| Study group | Role | What they receive |
|---|---|---|
| FCU offered | Experimental | Not described Receives: Behavioral: Family Check-Up |
| No feedback or services offered | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
growth in substance use
The Student Survey was collected from all youth, regardless of treatment condition, annually across 6th-10th grades. It includes 6 questions about the frequency with which the adolescent used 5 substances in the last month: cigarettes, chewing tobacco or snuff, alcohol (overall quantity and most at one time), marijuana or hashish, and other hard drugs. Growth curve modeling will be used to represent change in substance use across time.
Measured: 5 time points (6th grade, 7th grade, 8th grade, 9th grade, and 10th grade). Avg time between t1 and t2 was 15.1 mo.; avg time between t2 and t3 was 11.9 mo.; avg time between t3 and t4 was 11.4 mo.; avg time between t4 and t5 was 11.6 mo.
growth in antisocial behavior
The Student Survey was collected from all youth, regardless of treatment condition, annually across 6th-10th grades. It includes youth reports of engagement in antisocial behavior during the past month, measured by averaging across 11 items on a 6-point scale ranging from "never" to "more than 20 times" during the past month. The items included content such as lying to parents, staying out all night without permission, stealing, carrying a weapon, and physical aggression. Growth curve modeling will be used to represent change in antisocial behavior across time.
Measured: 5 time points (6th grade, 7th grade, 8th grade, 9th grade, and 10th grade). Avg time between t1 and t2 was 15.1 mo.; avg time between t2 and t3 was 11.9 mo.; avg time between t3 and t4 was 11.4 mo.; avg time between t4 and t5 was 11.6 mo.
growth in deviant peer involvement
The Student Survey was collected from all youth, regardless of treatment condition, annually across 6th-10th grades. It includes youth reports of the behavior of the friends with whom they have spent the most time in the past month. Youth are asked how many of these friends have engaged in 11 behaviors in the past month, using a 5-point scale ranging from "none" to "4 or more." The items include content such as selling illegal drugs, carrying a knife or handgun, and getting arrested. Growth curve modeling will be used to represent change in deviant peer involvement across time.
Measured: 5 time points (6th grade, 7th grade, 8th grade, 9th grade, and 10th grade). Avg time between t1 and t2 was 15.1 mo.; avg time between t2 and t3 was 11.9 mo.; avg time between t3 and t4 was 11.4 mo.; avg time between t4 and t5 was 11.6 mo.
Secondary outcomes (2)
growth in family management skills
The family assessment was collected from families who received the FCU; it includes caregiver and child assessment packets and parent-child videotaped interactions. Caregiver and child assessments include reports of family management, including parental monitoring and parent-school involvement. Videotaped interactions are evaluated and each family rated on factors such as supervision, listening skills, use of encouragement, and problem solving. Growth curve modeling will be used to represent change in family management skills across time.
Measured: 3 time points (7th grade, summer after 8th grade, and 10th grade). Average time between t1 and t2 was 15.4 months; average time between t2 and t3 was 17.0 months.
positive change in family relationship quality
The family assessment was collected from families who received the FCU; it includes caregiver and child assessment packets and parent-child videotaped interactions. Caregiver and child assessments include reports of positive relationship and family conflict. Videotaped interactions include seven 5-8 minute discussions on family-related matters. These interactions are evaluated and each family rated on positive relationship and family conflict. Growth curve modeling will be used to represent change in family relationship quality across time.
Measured: 3 time points (7th grade, summer after 8th grade, and 10th grade). Average time between t1 and t2 was 15.4 months; average time between t2 and t3 was 17.0 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startFeb 2006
- Primary completionJan 2010
- Study completionMar 2011
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
- Masking
- None (open label)
- Enrolment
- 593 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Elizabeth A Stormshak, PhD, Principal investigator, University of OregonThomas J Dishion, PhD, Principal investigator, University of OregonKathryn A Kavanagh, PhD, Principal investigator, University of OregonAllison S Caruthers, PhD, Study director, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490307
- Sponsor's protocol ID
- R01DA018374
- Other IDs
- R01DA018374
- Acronym
- PAL-2
- Status last verified
- Dec 2011
- First submitted
- 16 Aug 2011
- Last updated
- 12 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Seidman S, Danzo S, Connell A, Stormshak E. The Family Check-Up and Youth Suicide: Assessing Indirect Effects of Improving Self-Regulation and Reducing Depression in Promoting Long-Term Resilience. Suicide Life Threat Behav. 2025 Jun;55(3):e70029. doi: 10.1111/sltb.70029.
PubMed 40470833
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Family Intervention for Adolescent Problem Behavior
- ClinicalTrials.gov ID
- NCT01490307
- Acronym / sponsor ID
- PAL-2 / R01DA018374
- Conditions
- Substance Use, Conduct Disorder, Depression, Anxiety
- Keywords
- parenting intervention, Family Check-Up, Anxiety Disorders, Depression, Depressive Disorder, Conduct Disorder, Mental Disorders, Behavioral Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 593 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 12 Dec 2011 (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 goal of this project is to empirically refine and improve a comprehensive family-centered prevention strategy for reducing and preventing adolescent substance use and other problem behaviors. This project builds on 15 years of programmatic research underlying the development of the Family Check-up model (FCU), originally referred to as the Adolescent Transitions Program (ATP; Dishion \& Kavanagh, 2003), but later expanded as a general approach to mental health treatment for children from ages 2 through 17 (Dishion \& Stormshak, 2007). The FCU model is a multilevel, family-centered strategy delivered within the context of a public school setting that comprehensively links universal, selected, and indicated family interventions. Previous research and the investigators' practical experience working in school settings indicate that the intervention strategy needs improvement in 3 critical areas to build on previous significant effects and to enhance the potential for future dissemination and large-scale implementation:(a) improve the feasibility of both the universal level and the indicated level of the intervention by broadening the intervention components and systematically embedding these components into the current behavioral support systems in the schools; (b) address the transition from middle school to high school, with special attention to academic engagement and reduction of deviant peer clustering; and (c) explicitly incorporate principals of successful interventions with families and young adolescents of diverse ethnic groups into both the universal and indicated models. An additional general goal of this study is to develop, test, and refine a set of research-based instruments that facilitate evaluation, training, implementation, and monitoring of intervention fidelity to maximize the potential success of implementation and large-scale dissemination.
Participants include 593 youth and their families recruited from the 6th grade in three public middle schools in Portland, OR. Families were randomly assigned to receive either the FCU intervention model or treatment as usual. Assessments were collected for 5 years through the 10th grade. High school transition planning and intensive intervention efforts occurred in Grades 7-9.
The investigators tested the hypothesis that the FCU intervention will reduce the growth of problem behavior and substance use through the enhancement of family management and parent involvement in school.
Detailed description
Specific aims of the current project are to:
- Establish a Family Resource Center (FRC) that builds on school-wide behavior management;
- Extend the intervention model to explicitly address the high school transition;
- Develop intervention components specifically focused on the cultural enhancement with a broader youth population, and test the efficacy of these interventions for reducing risk and enhancing positive adjustment for youth and their families;
- Evaluate the preventive impact of family engagement on individual differences in the growth of deviant peer involvement, antisocial behavior, and tobacco, alcohol, and marijuana use during the critical transition to high school; and
- Develop a training and fidelity model related to change.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FCU offered | Experimental | Behavioral: Family Check-Up |
| No feedback or services offered | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parents of all sixth grade students across 2 cohorts at 3 public middle schools were invited to participate in this study.
Key exclusion criteria (0 listed)
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-UpAlso: Adolescent Transitions Project (ATP), Ecological Family Intervention and Treatment (EcoFIT)The Family Check-Up starts with a rapport-building session that allows therapists to gauge parents' concerns and motivation for change. This is followed by a thorough assessment of individual family strengths and weaknesses, utilizing parent and child questionnaires and family video observations. Parents then receive feedback on the results of the assessment using motivational interviewing techniques. Attention is focused on parents' and children's readiness to change, as well as the delineation of specific change options. Families may continued to receive tailored intervention services using the Everyday Parenting Curriculum. | Behavioural | FCU offered |
Primary outcome
growth in substance use
Time frame: 5 time points (6th grade, 7th grade, 8th grade, 9th grade, and 10th grade). Avg time between t1 and t2 was 15.1 mo.; avg time between t2 and t3 was 11.9 mo.; avg time between t3 and t4 was 11.4 mo.; avg time between t4 and t5 was 11.6 mo.
The Student Survey was collected from all youth, regardless of treatment condition, annually across 6th-10th grades. It includes 6 questions about the frequency with which the adolescent used 5 substances in the last month: cigarettes, chewing tobacco or snuff, alcohol (overall quantity and most at one time), marijuana or hashish, and other hard drugs. Growth curve modeling will be used to represent change in substance use across time.
growth in antisocial behavior
Time frame: 5 time points (6th grade, 7th grade, 8th grade, 9th grade, and 10th grade). Avg time between t1 and t2 was 15.1 mo.; avg time between t2 and t3 was 11.9 mo.; avg time between t3 and t4 was 11.4 mo.; avg time between t4 and t5 was 11.6 mo.
The Student Survey was collected from all youth, regardless of treatment condition, annually across 6th-10th grades. It includes youth reports of engagement in antisocial behavior during the past month, measured by averaging across 11 items on a 6-point scale ranging from "never" to "more than 20 times" during the past month. The items included content such as lying to parents, staying out all night without permission, stealing, carrying a weapon, and physical aggression. Growth curve modeling will be used to represent change in antisocial behavior across time.
growth in deviant peer involvement
Time frame: 5 time points (6th grade, 7th grade, 8th grade, 9th grade, and 10th grade). Avg time between t1 and t2 was 15.1 mo.; avg time between t2 and t3 was 11.9 mo.; avg time between t3 and t4 was 11.4 mo.; avg time between t4 and t5 was 11.6 mo.
The Student Survey was collected from all youth, regardless of treatment condition, annually across 6th-10th grades. It includes youth reports of the behavior of the friends with whom they have spent the most time in the past month. Youth are asked how many of these friends have engaged in 11 behaviors in the past month, using a 5-point scale ranging from "none" to "4 or more." The items include content such as selling illegal drugs, carrying a knife or handgun, and getting arrested. Growth curve modeling will be used to represent change in deviant peer involvement across time.
2 secondary outcomes
growth in family management skills
Time frame: 3 time points (7th grade, summer after 8th grade, and 10th grade). Average time between t1 and t2 was 15.4 months; average time between t2 and t3 was 17.0 months.
positive change in family relationship quality
Time frame: 3 time points (7th grade, summer after 8th grade, and 10th grade). Average time between t1 and t2 was 15.4 months; average time between t2 and t3 was 17.0 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 12 Dec 2011.
- Derived from this study: PubMed 40470833Seidman S, Danzo S, Connell A, Stormshak E. The Family Check-Up and Youth Suicide: Assessing Indirect Effects of Improving Self-Regulation and Reducing Depression in Promoting Long-Term Resilience. Suicide Life Threat Behav. 2025 Jun;55(3):e70029. doi: 10.1111/sltb.70029.
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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.
Elizabeth A Stormshak, PhD principal investigator
University of Oregon
Thomas J Dishion, PhD principal investigator
University of Oregon
Kathryn A Kavanagh, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Check-Up in people with Substance Use and Conduct Disorder, run by University of Oregon 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 1 inclusion and 0 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 12 Dec 2011. 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?
growth in substance use (time frame: 5 time points (6th grade, 7th grade, 8th grade, 9th grade, and 10th grade). Avg time between t1 and t2 was 15.1 mo.; avg time between t2 and t3 was 11.9 mo.; avg time between t3 and t4 was 11.4 mo.; avg time between t4 and t5 was 11.6 mo.). 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 NCT01490307, 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 12 Dec 2011.