Smoking Tobacco Clinical Trial
Official title:
Prevention Services in Schools for Early Drug Abuse Risk
This five-year prevention services application is concerned with preventing substance abuse, comorbid mental and behavioral disorders, and school failure. We will direct an integrated set of first grade classroom based preventive interventions at two correlated and confirmed early antecedents: early aggressive, disruptive behavior and poor achievement. We will test a comprehensive Whole Day (WD) program directed at improving: 1) teacher's classroom behavior management; 2) family/classroom partnerships regarding homework and discipline; and 3) teacher's instructional practices regarding academic subjects, particularly reading. We will test WD effectiveness in a developmental epidemiological design in which children and teachers are randomly assigned to intervention and standard setting (control) classrooms in 2 classrooms in each of 12 schools. While following the first grade children to the end of third grade, we will follow their first grade teachers over two subsequent cohorts of first graders to test whether the support and training structure sustains high levels of WD practice. We will also test whether the support and training structure is successful in training non-WD teachers. This prevention services aim will be augmented by an economic analysis of the costs and cost-effectiveness of the WD program. This combined services and prevention research should increase the efficiency of developing evidence-based programs and extending their use system-wide in both the prevention and education fields. The aims of our proposed work are to: 1) Implement and evaluate the effectiveness of a whole-day preventive intervention program for first-grade (WD) directed at known antecedent risk factors for later substance abuse, school failure, and comorbid mental and behavioral disorders; 2) Measure the variation in impact of WD due to variation in the experimentally manipulated quality of teachers' specific WD practices around classroom behavior management, family/classroom partnership, and quality of instruction, regarding reading, taking into account family, peer, and community factors; 3) Test effective- ness of the support structure required to sustain, and extend to other teachers high quality implementa- tion of WD; 4) Carry out economic analyses of the costs of implementing WD and their cost-effectiveness.
This five-year application is concerned with preventing substance abuse, comorbid mental and
behavioral disorders, and school failure. We will direct an integrated set of previously
tested preventive first-grade interventions at two correlated and confirmed early
antecedents: early aggressive, disruptive behavior and poor achievement. The interventions
we propose to integrate and test are directed at improving: 1) teacher's classroom behavior
management; 2) family/classroom partnerships regarding homework and discipline; and 3)
teacher's instructional practices regarding academic subjects, particularly reading. The
combined preventive and educational intervention strategy will be a single Whole Day (WD)
first-grade classroom program, built on the empirically determined recognition of the
interdependence of these risk factors across substance abuse and educational failure. As in
our past Baltimore preventive trials, we propose to test the effectiveness of WD in a
developmental epidemiological design in which children and teachers are randomly assigned to
intervention and standard setting conditions (controls; SC). A special aspect of this
proposal is that in the same design we propose laying a foundation for moving what we have
learned into policy and practice. While following the first-grade children as far as the end
of third grade, we will follow their first grade teachers over two subsequent cohorts of
first graders, to test whether the support and training structure sustains high levels of WD
practice. We will also test whether the support and training structure is successful in
training non-WD teachers, as far as the trial results warrant. This prevention services aim
will be augmented by an economic analysis of the costs and effectiveness of the WD program.
The research on effectiveness combined with research on moving from effectiveness to
practice should increase the efficiency of developing evidence-based programs faster and
earlier in both the prevention and education fields.
This grant would set the foundation for grants for following the cohort of study children
and teachers periodically to assess the preventive impact of the interventions on later
substance abuse and on extending teachers' use of WD practices. This prevention research in
Baltimore continues under the aegis of our Community and Institutional Board (see letters of
support). This proposal involves a close institutional collaboration among the American
Institutes for Research (AIR); Baltimore City Public School System (BCPSS); Morgan State
University (MSU); the Oregon Social Learning Center (OSLC); the Prevention Science and
Methodology Group (PSMG); the Johns Hopkins Bloomberg School of Public Health; and the
Center for Academic and Reading Skills at the University of Texas-Houston.
The aims of our proposed work are to
1. Implement and evaluate the effectiveness of a whole-day preventive intervention program
for first grade (WD) directed at reducing the antecedent risk factors for later
substance abuse, comorbid mental and behavioral disorders, and school failure.
2. Measure the variation in the impact of WD owing to variation in the experimentally
manipulated quality of teachers' specific WD practices around classroom behavior
management, family/classroom partnership, and quality of instruction, particularly
regarding reading. These analyses will include other sources of variation as well, in
the child and in the social contexts of family, classroom and school, peers, and
community.
3. Test the effectiveness of the support and training structure required to develop and
maintain high-quality implementation of WD a) during the effectiveness trial; then b)
as the results warrant, sustaining high-quality WD in consecutive cohorts of first
graders; and then c) extending the hypothesized higher quality of WD to other than WD
teachers.
4. Carry out economic analyses of the costs of implementing WD and their
cost-effectiveness compared with SC with respect to reductions in risk factors for
illicit substance abuse, as well as tobacco, HIV, school failure, and comorbid mental
and behavioral disorders.
B. Background and Significance Over the past three decades, evidence from developmental
epidemiological studies has consistently identified specific antecedent risk factors at
least as early as first grade as predictive of later substance abuse and comorbid mental and
behavioral disorders during the middle school years and beyond (Cairns, Cairns, & Neckerman,
1995; Farrington, 1995; Hawkins, Catalano, & Miller, 1992; Hawkins, Doueck, & Lishner, 1988;
Kellam, Brown, Rubin, & Ensminger, 1983; Reid, 1993; Reid & Eddy, 1997). Many of these
antecedents are exhibited in the school setting, such as aggressive, disruptive behavior in
first grade and its strong correlate, poor academic achievement. These early risk factors
can lead to later substance abuse and school dropout, which have considerable economic,
social, and psychological consequences (Dishion, Capaldi, & Yoerger, 1999; Eddy, Reid, &
Fetrow, 2000; Hawkins et al., 1992; Kellam et al., 1983; Kellam, Mayer, Rebok, & Hawkins,
1998; Maguin & Loeber, 1996; Mrazek & Haggerty, 1994; Reid, Eddy, Fetrow, & Stoolmiller,
1999 [see Appendix-1 for paper]). These risk factors are also strongly related to a host of
other risk factors that separately or together are predictive during adolescence and young
adulthood of not only drug abuse, but also conduct disorders and violence, depression,
school drop out, and high-risk sexual behaviors. Ineffective parenting around discipline and
homework; classrooms with high levels of aggressive, disruptive behavior; antisocial
classmates and peers; poverty at the family level and at the school and community levels,
and individual differences such as sensation seeking (Wills, Sandy, & Yaeger, 2000;
Palmgreen, Donohew, Lorch, Hoyle, & Stephenson, 2001)—all have been found to increase the
risk of drug abuse and related comorbid problems (Ary et al., 1999; Dishion et al., 1999;
Kellam, Ling, Meriska, Brown, & Ialongo, 1998 [see Appendix-2 for paper]; Reid, Patterson, &
Snyder, in press).
In Baltimore, in Oregon, and elsewhere, rigorous, developmental, epidemiologically based,
randomized field trials have directed interventions at decreasing the early risk factors in
the classroom, family, and peer-group settings. These trials indicate that school-based
universal interventions (i.e., those addressing all children, not merely those at higher
risk) can have short-term beneficial effects on aggressive behavior and achievement (Dolan
et al., 1993; Ialongo et al., 1999; Reid, et al., 1999), off-task behavior (Brown, 1994a,
1993b), and depressive symptoms (Kellam, Rebok, Mayer, Ialongo, & Kalodner, 1994). Impact
from first grade interventions to reduced aggression in middle school has been reported
(Kellam, Rebok, Ialongo, & Mayer [see Appendix-3 for paper], 1994; Kellam, Ling et al.,
1998), and delinquency (Eddy et al., 2000). Longer-term effects on illicit drug use have
been observed in the Baltimore work (see Figure 1). Reductions in the initiation of tobacco
use have been shown as a result of the Baltimore first grade preventive interventions in
three separate cohorts (Kellam & Anthony, 1998 [see Appendix-4 for paper]; Storr, Ialongo,
Kellam, & Anthony, in press). Longer-term impact has been reported in meta-analyses on
illicit drug use by Nan Tobler and colleagues (1986; 2000; Tobler et al., 2000) plus other
meta-analyses (Derzon & Lipsey, 1999; Gorman, 1995). Higher-fidelity implementation of the
interventions also led to higher impact (Ialongo et al., 1999 [see Appendix-5 for paper],
Ialongo, Poduska, Werthamer, & Kellam, 2001 [see Appendix-6 for paper]). Further, we have
found compelling evidence that these universal interventions often have the greatest impact
on those at highest risk of substance abuse and aggression (Brown & Liao, 1999 [see
Appendix-7 for paper]; Curran & Muthèn, 1999; Muthèn & Curran, 1997; Muthèn et al.,
submitted; Stoolmiller, Eddy, & Reid, 2000 [see Appendix-8 for paper]).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05920772 -
Process and Effect Evaluation of the KickAsh! Intervention
|
N/A | |
Completed |
NCT03657511 -
Tobacco Cessation Intervention
|
N/A | |
Completed |
NCT00608426 -
Proactive Tobacco Treatment for Veterans
|
N/A |