The randomized controlled trial Fast Track multilevel intervention for children with early-emerging conduct problems breaks intergenerational transmission of violence across three generations

ERCT Criteria Breakdown

• Level 1 Criteria

  • C

    Class-level RCT

    • Schools (matched sets of schools) were randomly assigned, so the unit of randomization was at least class-level and in fact school-level.
    • "Within each site, the schools were divided into one to three paired sets of schools, and one set in each pair was randomly assigned to intervention and control conditions."
    • Relevant Quotes: 1) "In high-risk elementary schools located in the United States, children considered at high risk for aggressive behavior based on teachers’ and parents’ screen scores were assigned to either a 10-year intervention or a control group based on their school." (p. 1) 2) "Within each site, the schools were divided into one to three paired sets of schools, and one set in each pair was randomly assigned to intervention and control conditions." (p. 3) 3) "yielding a sample of 891 children from G2 (intervention group, N = 445; control group, N = 446; see Figure 1 CONSORT Diagram and CPPRG, 2020 for further details)." (p. 3) Detailed Analysis: Criterion C requires randomization at the class level (or stronger, such as school-level) to reduce within-class contamination. The paper states that assignment was "based on their school" and explicitly describes that schools were paired and then "randomly assigned" to intervention versus control. Because the unit of randomization is the school (or school set), this is stronger than class-level randomization and therefore satisfies Criterion C. Final Summary: Criterion C is met because randomization occurred by school (or school set), not within a single classroom.
  • E

    Exam-based Assessment

    • Outcomes were measured with mental health instruments (e.g., SDQ), not standardized exam-based academic assessments.
    • "Primary outcome: children with G3’s mental health problems. When individuals from G2 were age 34, children from G3’s mental health was measured by parents from G2 report with the Strengths and Difficulties Questionnaire (SDQ; Goodman, Lamping, & Ploubidis, 2010; Goodman, 2001), a 25-item normed measure designed to capture children’s mental health difficulties."
    • Relevant Quotes: 1) "Primary outcome: children with G3’s mental health problems. When individuals from G2 were age 34, children from G3’s mental health was measured by parents from G2 report with the Strengths and Difficulties Questionnaire (SDQ; Goodman, Lamping, & Ploubidis, 2010; Goodman, 2001), a 25-item normed measure designed to capture children’s mental health difficulties." (p. 4) 2) "Predictors: individuals from G1’s intimate partner violence and parent to child violence. Individuals from G1’s IPV and PCV, as well as individuals from G2’s PCV, were each derived from the Conflict Tactics Scale (Straus, 1979)." (p. 4) Detailed Analysis: Criterion E requires standardized exam-based assessments of educational outcomes (e.g., national/state standardized achievement tests). In this paper, the primary outcomes are children’s mental health difficulties (SDQ) and violence-related constructs (Conflict Tactics Scale). These are not academic exam outcomes, and the paper does not report use of standardized academic achievement exams as the primary assessment method for educational outcomes. Final Summary: Criterion E is not met because the study does not use standardized exam-based academic assessments as outcomes.
  • T

    Term Duration

    • The intervention began in Grade 1 and outcomes used in this paper were assessed decades later (age 34), exceeding one term.
    • "Intervention components were delivered to the first two generations (i.e., G1 parents and G2 children) from 1st through 10th Grade, with first sessions beginning in October of Grade 1."
    • Relevant Quotes: 1) "Intervention components were delivered to the first two generations (i.e., G1 parents and G2 children) from 1st through 10th Grade, with first sessions beginning in October of Grade 1." (p. 3) 2) "In 2020–2021, when the original children from G2 were adults and age 34, 374 participants from G2 (92% of eligible G2s; n = 191 intervention group, n = 183 control group) were invited to complete a survey that assessed their relationship with their romantic partner (if they had one), and their parenting of their children from G3." (p. 3) Detailed Analysis: Criterion T requires outcomes to be measured at least one academic term (~3–4 months) after the intervention begins. The intervention began in October of Grade 1 and continued through Grade 10. The measurements used in this paper include follow-up assessments in 2020–2021 when participants were age 34, which is far beyond one academic term after intervention start. Final Summary: Criterion T is met because the follow-up window is far longer than one academic term after intervention start.
  • D

    Documented Control Group

    • The control group is described as receiving no intervention and the paper reports control-group sample sizes and pre-treatment comparisons.
    • "The families in the control group were followed over time, completed all questionnaires, but did not receive any intervention (therefore, they were free to seek other services if needed)."
    • Relevant Quotes: 1) "yielding a sample of 891 children from G2 (intervention group, N = 445; control group, N = 446; see Figure 1 CONSORT Diagram and CPPRG, 2020 for further details)." (p. 3) 2) "The families in the control group were followed over time, completed all questionnaires, but did not receive any intervention (therefore, they were free to seek other services if needed)." (p. 3) 3) "The parents from G2 subsample and the initial sample from G2, and the parents from G2 intervention and control samples only differed on a combined 8 of 58 tests of pre-treatment and demographic differences between groups (see Table S1)." (p. 5) Detailed Analysis: Criterion D requires that the control group be documented, including who they were, what they did/did not receive, and baseline comparability information. The paper reports intervention and control sample sizes, explicitly states the control group "did not receive any intervention," and notes that pre-treatment and demographic differences between groups were tested (with details referenced in Table S1). Final Summary: Criterion D is met because the paper clearly documents the control condition and reports baseline comparability testing.

• Level 2 Criteria

  • S

    School-level RCT

    • Randomization/assignment occurred at the school (matched school set) level.
    • "Within each site, the schools were divided into one to three paired sets of schools, and one set in each pair was randomly assigned to intervention and control conditions."
    • Relevant Quotes: 1) "In high-risk elementary schools located in the United States, children considered at high risk for aggressive behavior based on teachers’ and parents’ screen scores were assigned to either a 10-year intervention or a control group based on their school." (p. 1) 2) "Within each site, the schools were divided into one to three paired sets of schools, and one set in each pair was randomly assigned to intervention and control conditions." (p. 3) 3) "High-risk elementary schools (n = 53) were selected for Fast Track participation based on neighborhood crime and poverty rates in Durham, NC; Nashville, TN; rural Pennsylvania; and Seattle, WA." (p. 3) Detailed Analysis: Criterion S requires school-level (or equivalent site-level) randomization. The paper states that children were assigned based on their school and describes random assignment of paired sets of schools to intervention and control. This indicates randomization occurred at the school (or school cluster) level. Final Summary: Criterion S is met because allocation to condition was randomized by school (paired school sets).
  • I

    Independent Conduct

    • The paper discloses that key investigators are developers of the Fast Track curriculum/PATHS curriculum, and it does not clearly document independent third-party evaluation.
    • "K.L.B., J.D.C., K.A.D., M.T.G., J.E.L., and R.J.M. are the developers of the Fast Track curriculum and have a publishing and royalty agreement with Guilford Publications, Inc."
    • Relevant Quotes: 1) "K.L.B., J.D.C., K.A.D., M.T.G., J.E.L., R.J.M., and E.E.P. are the Principal Investigators on the Fast Track Project and have a publishing agreement with Guilford Publications, Inc." (p. 12) 2) "K.L.B., J.D.C., K.A.D., M.T.G., J.E.L., and R.J.M. are the developers of the Fast Track curriculum and have a publishing and royalty agreement with Guilford Publications, Inc." (p. 12) Detailed Analysis: Criterion I requires that study conduct (implementation and/or evaluation) be independent from the intervention designers/providers to reduce bias, typically supported by explicit statements of independent data collection and analysis. The acknowledgements disclose that core Fast Track investigators are also developers of the Fast Track curriculum (and related materials). The paper does not provide a clear statement that the evaluation for this study (data collection/analysis and conclusions) was conducted by an independent third-party team separate from the program’s developers. Final Summary: Criterion I is not met because the paper indicates developer involvement and does not clearly document independent conduct.
  • Y

    Year Duration

    • Outcomes considered in this paper were assessed many years after intervention start, far exceeding 75% of an academic year.
    • "In 2020–2021, when the original children from G2 were adults and age 34, 374 participants from G2 (92% of eligible G2s; n = 191 intervention group, n = 183 control group) were invited to complete a survey..."
    • Relevant Quotes: 1) "Intervention components were delivered to the first two generations (i.e., G1 parents and G2 children) from 1st through 10th Grade, with first sessions beginning in October of Grade 1." (p. 3) 2) "In 2020–2021, when the original children from G2 were adults and age 34, 374 participants from G2 (92% of eligible G2s; n = 191 intervention group, n = 183 control group) were invited to complete a survey..." (p. 3) Detailed Analysis: Criterion Y requires outcome measurement at least 75% of an academic year after the intervention begins. Here, the intervention began in Grade 1 (October) and the measurements used in this paper include follow-up at age 34 (2020–2021). This exceeds a full academic year by a very large margin. Final Summary: Criterion Y is met because outcomes were measured many years after the intervention began.
  • B

    Balanced Control Group

    • The intervention provided substantial additional programming, but those resources are integral to the Fast Track treatment being tested versus a no-intervention/business-as-usual control.
    • "During elementary school, all families in the intervention group were offered parent training with home visiting, academic tutoring, and social skills."
    • Relevant Quotes: 1) "During elementary school, all families in the intervention group were offered parent training with home visiting, academic tutoring, and social skills." (p. 3) 2) "a teacher-implemented, universal social–emotional learning curriculum (Kusch€e & Greenberg, 2020) was provided to children from G2 for an average of 2 to 3 lessons per week at all sites through Grade 5..." (p. 3) 3) "The families in the control group were followed over time, completed all questionnaires, but did not receive any intervention (therefore, they were free to seek other services if needed)." (p. 3) Detailed Analysis: Criterion B evaluates whether time and resources (e.g., instructional time, tutoring, materials, staff support) are balanced across intervention and control conditions, unless the additional resources are explicitly integral to the treatment being tested (i.e., the added resources are the treatment package). The intervention clearly adds resources: parent training, home visiting, academic tutoring, and a curriculum delivered multiple times per week. The control group did not receive the intervention. Applying the ERCT Criterion B decision logic: extra resources are present, but they are not framed as separable confounds; they are the defined Fast Track intervention components (the treatment package) being evaluated against a no-Fast-Track control. Under the ERCT exception, this supports marking Criterion B as met (the study is explicitly testing a comprehensive program that inherently includes those added inputs). Final Summary: Criterion B is met because the added time/materials/services are integral components of the Fast Track intervention being tested.

• Level 3 Criteria

  • R

    Reproduced

    • No peer-reviewed independent replication by a different research team (with clearly documented reproduction of this study) was identified.
    • Relevant Quotes: 1) None found in the target paper indicating independent replication by a different research team. Detailed Analysis: Criterion R requires an independently replicated study by a different research team in a different context, published in a peer-reviewed journal, with clear evidence (and quotes) that the study reproduced the original intervention and design. The target paper describes the Fast Track trial and cites prior Fast Track publications, but it does not describe an independent replication. An internet search was conducted for independent replications of the Fast Track intervention RCT; however, no clearly identified peer-reviewed replication study by a separate author team that explicitly reproduces this trial (with quotable confirmation) was found in accessible sources for this check. Final Summary: Criterion R is not met because independent replication evidence with verifiable quotes was not identified.
  • A

    All-subject Exams

    • Because exam-based academic assessment (Criterion E) is not met, the all-subject standardized-exams requirement is also not met.
    • Relevant Quotes: 1) "Primary outcome: children with G3’s mental health problems. When individuals from G2 were age 34, children from G3’s mental health was measured by parents from G2 report with the Strengths and Difficulties Questionnaire (SDQ...)" (p. 4) Detailed Analysis: Criterion A requires standardized exam-based assessments across all main academic subjects, and it cannot be met if Criterion E is not met. This paper evaluates mental health/behavioral outcomes (SDQ) rather than standardized academic exams, and it does not report all-subject academic exam outcomes. Final Summary: Criterion A is not met because Criterion E is not met and the paper does not use all-subject standardized academic exams.
  • G

    Graduation Tracking

    • Although the target paper focuses on violence/mental health outcomes, a follow-up publication on the same Fast Track RCT explicitly ascertained whether participants graduated from high school or received a GED.
    • "Two scores (0=no, l=yes) were created from the 8-item Education Information and the 46-item Employment History measures from the National Longitudinal Surveys (59) to ascertain whether the respondent graduated from high school or received a GED and was currently employed full-time or enrolled in higher education."
    • Relevant Quotes: 1) "In 2020–2021, when the original children from G2 were adults and age 34, 374 participants from G2 ... were invited to complete a survey..." (p. 3) 2) From a follow-up paper on the same randomized trial cohort (Dodge et al., 2015, age-25 follow-up): "Two scores (0=no, l=yes) were created from the 8-item Education Information and the 46-item Employment History measures from the National Longitudinal Surveys (59) to ascertain whether the respondent graduated from high school or received a GED and was currently employed full-time or enrolled in higher education." (Methods: Measures; page numbers not provided in the HTML version) Detailed Analysis: Criterion G requires that participants be tracked through graduation (i.e., follow-up long enough to capture graduation outcomes and explicit reporting of graduation status). The target paper itself does not present educational graduation outcomes and focuses on intergenerational IPV/PCV and G3 mental health. However, ERCT allows graduation-tracking evidence to be demonstrated in subsequent papers from the same study cohort. The Dodge et al. (2015) follow-up publication on the Fast Track randomized trial explicitly reports that the study ascertained whether participants "graduated from high school or received a GED." This is direct evidence that the cohort was followed long enough and measured through the high-school graduation endpoint (or an equivalent completion credential). Final Summary: Criterion G is met because follow-up reporting for the same Fast Track RCT cohort explicitly ascertained high-school graduation (or GED).
  • P

    Pre-Registered

    • The ClinicalTrials.gov registration was first submitted in 2012, while the study start date is in 1991, so the protocol was not pre-registered before the study began.
    • "#### Study Start March 1, 1991 ... #### First Submitted July 16, 2012"
    • Relevant Quotes: 1) "Trial registration The Fast Track trial was registered at clinicaltrials.gov (identifier number: NCT01653535). First submitted 2012-07-16." (p. 12) 2) "The Fast Track intervention, launched in the early 1990s..." (p. 2) 3) From the ClinicalTrials.gov study record (NCT01653535) as displayed by the Clinical Trials Registry - ICH GCP mirror: "#### Study Start March 1, 1991" (Study record dates) "#### First Submitted July 16, 2012" (Study record dates) Detailed Analysis: Criterion P requires that the study protocol be pre-registered before the study begins (i.e., registration date must precede study start / data collection start). The target paper reports that the Fast Track trial registration was "First submitted 2012-07-16." It also characterizes Fast Track as launched in the early 1990s. The ClinicalTrials.gov record dates further indicate a "Study Start" of March 1, 1991 and a "First Submitted" date of July 16, 2012. This demonstrates that registration occurred long after the study began, and therefore is not prospective pre-registration of the original trial protocol. Final Summary: Criterion P is not met because registration occurred after study start (1991) rather than before it.