Adolescent Problem Behavior at SchoolPhase 1/2NCT01323231
XY-Zone Program Evaluation: A School-Based Dropout Prevention Program for At-Risk Youth
A Phase 1/2 study testing XY-Zone in people with Adolescent Problem Behavior at School and Risk Behavior, run by University of Texas at Austin at 1 site in United States.
Trial summary
The objective of this study is to build upon preliminary research and conduct a pilot feasibility randomized controlled trial on a promising culturally-grounded and gender-specific treatment program, the XY-Zone. Read more about this study
- Who is it for?
- Ages 13 to 20 years, men only
- Conditions the study is for
- Adolescent Problem Behavior at School, Risk Behavior, Truancy; Socialized
- What is being tested?
- XY-Zone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to May 2012
- Phase
- Phase 1/2
- 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 13 to 20 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Students eligible to receive the XY-Zone must display one of the following risk factors:
- academic risks (failed classes, failed state examination text, lack of class participation, and homework incompletion)
- attendance risks (absences and tardies)
- behavioral risks (gang involvement, substance use, classroom conduct, social skills, self-esteem, violence, delinquent conduct, and family or emotional crisis)and
- social service issues (difficulty with the following: college readiness, life skills, health, career/employment, housing, day care, and grief or loss).
Who cannot join
- Youth who do not display any of the identified risk factors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: XY-Zone Phase 1 Program Evaluation: A School-Based Dropout Prevention Program for At-Risk Male Youth
The objective of this study is to build upon preliminary research and conduct a pilot feasibility randomized controlled trial on a promising culturally-grounded and gender-specific treatment program, the XY-Zone. The central hypothesis underlying this study purports that through receiving the XY-Zone treatment, adolescents will decrease their risk for dropping out of school. This hypothesis is supported by two years of preliminary data investigating the effectiveness of the XY-Zone.
To test the central hypothesis, the following specific aims will be pursued:
- Identify school dropout risk and protective factors (protective factors defined as: adult support and peer support; risk factors defined as: low school attendance, inability to achieve grade promotion, substance use, delinquency, school disconnectedness, misbehavior, disconnection from healthy peers) directly changed as a result of XY-Zone intervention.
- Determine the extent to which moderating variables (affective strength, duration in the program, family functioning, interpersonal strength, intrapersonal strength, level achieved in the program, and resiliency) effect change in outcome variables (risk and protective factors).
- Identify participants' beliefs about the impact of the mechanisms of change (respect, responsibility, relationship, role modeling, and reaching out) on outcome variables (risk and protective factors ) to enrich understanding of quantitative data.
- Being tested
- XY-Zone
- Keywords
- XY-Zone, school drop-out risk, protective factors, truancy
- Medical subject headings
- Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XY-ZoneBehavioural
The XY-Zone works to empower students to decrease risk factors and increase protective factors through three linear treatment steps. The first step is driven by guiding principles known as the five R's: respect, responsibility, relationship, role modeling, and reaching out. Through these principles, the participant explores healthy psychosocial behaviors and thoughts in a structured 10 session group setting. The leadership step builds upon the guiding principles and employs activities exploring true leadership through 10 sessions. During the leadership step, participants organize and carry out a service learning projects in their community. The third and final step is ambassador. Those in the ambassador step become a mentor to those in step one and are "expected to explore the principles of leadership and the five R's, and determine their personal relevance to their lives as young men" (Allen, 2009, p. i).
| Study group | Role | What they receive |
|---|---|---|
| Communities in Schools Services | Experimental | Communities in Schools services include case management, mental health services, mentorship services, after school programs, and academic assistance. Receives: Behavioral: XY-Zone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Youth Self Report
The Youth Self Report (Achenbach, 1991) is a 112-item scale designed for ages 11-18 years. Items are rated on a three-point scale from 0=never to 2=always true in the past 6 months. Eleven subscales can be calculated from the data, including: withdrawn, somatic complaints, anxious/depressed, social problems, thought problems, attention problems, delinquent behavior, aggressive behavior, self-destructive, and internalizing and externalizing behaviors. Scoring of subscales is gender specific. Test-retest reliability has been shown to be good (r=.84-.91).
Measured: One Year
Substance Use Self Report
Self-report data on alcohol and other drug use will be collected through items adapted from the Adolescent DATOS survey, which was used with more than 3,000 adolescents (Kristiansen \& Hubbard, 2001; Hser, Grella, et al., 2001).
Measured: One Year
School Records
School records offer attendance, truancy, grades, grade promotion, and behavioral referral information.
Measured: One Year
Secondary outcomes (2)
Behavioral and Emotional Rating Scale- II (Youth Report)
This 57 item Likert-style scale is designed for youth ages 11-18. The BERS-II (Epstein et al., 2004) assesses six dimensions: interpersonal strength, family involvement, intrapersonal strength, school functioning, affective strength, and career and vocational strength. The BERS-II youth report has strong internal consistency (alpha=.81-.91) and good test-retest reliability (r=.84-.91).
Measured: One Year
Resilience Scale
The resilience scale (Wagnild \& Young, 1993) is a 25 item designed to measure resiliency across various populations and is appropriate for youth. Items are rated on a seven-point scale (1= strongly disagree to 7= strongly agree) and have good internal consistency (alpha= .85-.94).
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Adolescent Problem Behavior at SchoolStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Ronya and George Kozmetsky (RGK) Foundation
- Responsible party
- Principal investigator, Katherine Montgomery, University of Texas at Austin
- Investigators
- Katherine L Montgomery, PhD, MSSW, Principal investigator, Washington University in Saint LouisDavid W Springer, PhD, Study chair, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323231
- Sponsor's protocol ID
- IRB -2010-05-0092
- Status last verified
- Jul 2013
- First submitted
- 24 Mar 2011
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Allen, A. (2008). The XY-Zone project evaluation of Communities in Schools-Central Texas. Independent Outcome Evaluation.
Achenbach, T.M. (1991). Manual for the Child Behavior Checklist/ 4-18 and 1991 Profile. Burlington, VT: University of Vermont Department of Psychiatry.
Epstein, M.H., Mooney, P., Ryser, G., & Pierce, C.D. (2004). Validity and reliability of the behavioral and emotional rating scale (2nd edition): Youth rating scale. Research on Social Work Practice, 14, 358-367.
Hser YI, Grella CE, Hubbard RL, Hsieh SC, Fletcher BW, Brown BS, Anglin MD. An evaluation of drug treatments for adolescents in 4 US cities. Arch Gen Psychiatry. 2001 Jul;58(7):689-95. doi: 10.1001/archpsyc.58.7.689.
PubMed 11448377Kristiansen, P.L. & Hubbard, R.L. (2001). Methodological overview and research design for adolescents in the drug abuse treatment outcome studies. Journal of Adolescent Research, 16, 545-562.
Wagnild GM, Young HM. Development and psychometric evaluation of the Resilience Scale. J Nurs Meas. 1993 Winter;1(2):165-78.
PubMed 7850498Singer, J. D. and Willett, J. B. (2003). Applied longitudinal data analysis: Methods for studying change and event occurrence. New York: Oxford University Press.
Creswell J.W. (2007). Qualitative inquiry and research design: Choosing among five approaches. 2nd ed. Thousand Oaks, CA: Sage.
Miles M.B. & Huberman, A.M. (1994). Making good sense: Drawing and verifying conclusions. Thousand Oaks, CA: Sage.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XY-Zone Phase 1 Program Evaluation: A School-Based Dropout Prevention Program for At-Risk Male Youth
- ClinicalTrials.gov ID
- NCT01323231
- Acronym / sponsor ID
- IRB -2010-05-0092
- Keywords
- XY-Zone, school drop-out risk, protective factors, truancy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Ronya and George Kozmetsky (RGK) Foundation
- Study start
- Aug 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Mar 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 objective of this study is to build upon preliminary research and conduct a pilot feasibility randomized controlled trial on a promising culturally-grounded and gender-specific treatment program, the XY-Zone. The central hypothesis underlying this study purports that through receiving the XY-Zone treatment, adolescents will decrease their risk for dropping out of school. This hypothesis is supported by two years of preliminary data investigating the effectiveness of the XY-Zone.
To test the central hypothesis, the following specific aims will be pursued:
- Identify school dropout risk and protective factors (protective factors defined as: adult support and peer support; risk factors defined as: low school attendance, inability to achieve grade promotion, substance use, delinquency, school disconnectedness, misbehavior, disconnection from healthy peers) directly changed as a result of XY-Zone intervention.
- Determine the extent to which moderating variables (affective strength, duration in the program, family functioning, interpersonal strength, intrapersonal strength, level achieved in the program, and resiliency) effect change in outcome variables (risk and protective factors).
- Identify participants' beliefs about the impact of the mechanisms of change (respect, responsibility, relationship, role modeling, and reaching out) on outcome variables (risk and protective factors ) to enrich understanding of quantitative data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Communities in Schools Services | Experimental | Behavioral: XY-ZoneCommunities in Schools services include case management, mental health services, mentorship services, after school programs, and academic assistance. |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Students eligible to receive the XY-Zone must display one of the following risk factors:
Key exclusion criteria (1 listed)
- Youth who do not display any of the identified risk factors
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 |
|---|---|---|
| XY-ZoneThe XY-Zone works to empower students to decrease risk factors and increase protective factors through three linear treatment steps. The first step is driven by guiding principles known as the five R's: respect, responsibility, relationship, role modeling, and reaching out. Through these principles, the participant explores healthy psychosocial behaviors and thoughts in a structured 10 session group setting. The leadership step builds upon the guiding principles and employs activities exploring true leadership through 10 sessions. During the leadership step, participants organize and carry out a service learning projects in their community. The third and final step is ambassador. Those in the ambassador step become a mentor to those in step one and are "expected to explore the principles of leadership and the five R's, and determine their personal relevance to their lives as young men" (Allen, 2009, p. i). | Behavioural | Communities in Schools Services |
Primary outcome
Youth Self Report
Time frame: One Year
The Youth Self Report (Achenbach, 1991) is a 112-item scale designed for ages 11-18 years. Items are rated on a three-point scale from 0=never to 2=always true in the past 6 months. Eleven subscales can be calculated from the data, including: withdrawn, somatic complaints, anxious/depressed, social problems, thought problems, attention problems, delinquent behavior, aggressive behavior, self-destructive, and internalizing and externalizing behaviors. Scoring of subscales is gender specific. Test-retest reliability has been shown to be good (r=.84-.91).
Substance Use Self Report
Time frame: One Year
Self-report data on alcohol and other drug use will be collected through items adapted from the Adolescent DATOS survey, which was used with more than 3,000 adolescents (Kristiansen \& Hubbard, 2001; Hser, Grella, et al., 2001).
School Records
Time frame: One Year
School records offer attendance, truancy, grades, grade promotion, and behavioral referral information.
2 secondary outcomes
Behavioral and Emotional Rating Scale- II (Youth Report)
Time frame: One Year
Resilience Scale
Time frame: One Year
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 10 Jul 2013.
- BackgroundAllen, A. (2008). The XY-Zone project evaluation of Communities in Schools-Central Texas. Independent Outcome Evaluation.
- BackgroundAchenbach, T.M. (1991). Manual for the Child Behavior Checklist/ 4-18 and 1991 Profile. Burlington, VT: University of Vermont Department of Psychiatry.
- BackgroundEpstein, M.H., Mooney, P., Ryser, G., & Pierce, C.D. (2004). Validity and reliability of the behavioral and emotional rating scale (2nd edition): Youth rating scale. Research on Social Work Practice, 14, 358-367.
- Background: PubMed 11448377Hser YI, Grella CE, Hubbard RL, Hsieh SC, Fletcher BW, Brown BS, Anglin MD. An evaluation of drug treatments for adolescents in 4 US cities. Arch Gen Psychiatry. 2001 Jul;58(7):689-95. doi: 10.1001/archpsyc.58.7.689.
- BackgroundKristiansen, P.L. & Hubbard, R.L. (2001). Methodological overview and research design for adolescents in the drug abuse treatment outcome studies. Journal of Adolescent Research, 16, 545-562.
- Background: PubMed 7850498Wagnild GM, Young HM. Development and psychometric evaluation of the Resilience Scale. J Nurs Meas. 1993 Winter;1(2):165-78.
- BackgroundSinger, J. D. and Willett, J. B. (2003). Applied longitudinal data analysis: Methods for studying change and event occurrence. New York: Oxford University Press.
- BackgroundCreswell J.W. (2007). Qualitative inquiry and research design: Choosing among five approaches. 2nd ed. Thousand Oaks, CA: Sage.
- BackgroundMiles M.B. & Huberman, A.M. (1994). Making good sense: Drawing and verifying conclusions. Thousand Oaks, CA: Sage.
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The Families and Middle School Success Project
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Prevention Programme for Improvement of Well-being and Level of Participation in Adolescents With Enhanced Psychiatric Burden in the School Environment.
Blended-care Counselling, Digital and Mental Literacy Training
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.
Katherine L Montgomery, PhD, MSSW principal investigator
Washington University in Saint Louis
David W Springer, PhD study chair
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XY-Zone in people with Adolescent Problem Behavior at School and Risk Behavior, run by University of Texas at Austin 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 5 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 10 Jul 2013. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Youth Self Report (time frame: One Year). 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 NCT01323231, which also lists 9 linked publications.
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 10 Jul 2013.