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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01323231
Other study ID # IRB -2010-05-0092
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received March 24, 2011
Last updated July 8, 2013
Start date August 2011
Est. completion date May 2012

Study information

Verified date July 2013
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. 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:

1. 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.

2. 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).

3. 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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Male
Age group 13 Years to 20 Years
Eligibility Inclusion Criteria:

- 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).

Exclusion Criteria:

- Youth who do not display any of the identified risk factors

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
XY-Zone
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).

Locations

Country Name City State
United States Communities in Schools Austin Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Texas at Austin Ronya and George Kozmetsky (RGK) Foundation

Country where clinical trial is conducted

United States, 

References & Publications (9)

Achenbach, T.M. (1991). Manual for the Child Behavior Checklist/ 4-18 and 1991 Profile. Burlington, VT: University of Vermont Department of Psychiatry.

Allen, A. (2008). The XY-Zone project evaluation of Communities in Schools-Central Texas. Independent Outcome Evaluation.

Creswell J.W. (2007). Qualitative inquiry and research design: Choosing among five approaches. 2nd ed. Thousand Oaks, CA: Sage.

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.

Hesr, Y., Grella, C.E., Hubbard, R.L., Hsieh, S.C., Fletcher, B.W., Brown, B.S., & Anglin, M.D. (2001). An evaluation of drug treatment for adolescents in four United States cities. Archives of General Psychiatry, 58, 689-695.

Kristiansen, 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.

Miles M.B. & Huberman, A.M. (1994). Making good sense: Drawing and verifying conclusions. Thousand Oaks, CA: Sage.

Singer, J. D. and Willett, J. B. (2003). Applied longitudinal data analysis: Methods for studying change and event occurrence. New York: Oxford University Press.

Wagnild GM, Young HM. Development and psychometric evaluation of the Resilience Scale. J Nurs Meas. 1993 Winter;1(2):165-78. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). One Year
Primary 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). One Year
Primary School Records School records offer attendance, truancy, grades, grade promotion, and behavioral referral information. One Year
Secondary 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). One Year
Secondary 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). One Year
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