- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04075019
The Seattle Social Development Project: An Implementation of the Raising Healthy Children Intervention (SSDP)
The Seattle Social Development Project: A Quasi-experimental Test of the Raising Healthy Children (RHC) Intervention With Teachers, Parents, and Students in Grades 1 to 6 in Elementary Schools Serving Children From High Crime Urban Areas
Study Overview
Status
Conditions
Detailed Description
The study asked whether delivering the intervention package over the full course of elementary school from grades 1 through 6 ("full intervention") had effects on academic and behavioral health outcomes; whether delivering the intervention just prior to adolescence in grades 5 and 6 only ("late intervention") had effects on academic and behavioral health outcomes; and whether offering parenting interventions only when participants were in grades 5 and 6 ("parenting only intervention") had effects on academic and behavioral health outcomes when compared with outcomes for students who were not assigned to intervention classrooms. This study examined this question by comparing outcomes for four separate groups, a "full intervention group" exposed to the interventions through grades 1-6, a "late intervention group" exposed to the interventions only in grades 5 and 6, a minimal "parent-training only group" (grades 5 and 6), and a control group that received no special intervention. The intervention package consisted of the following components:
Teacher Training In Classroom Instruction and Management included training in (a) proactive classroom management (establish consistent classroom expectations and routines at the beginning of the year; give clear, explicit instructions for behavior; recognize and reward desirable student behavior and efforts to comply; use methods that keep minor classroom disruptions from interrupting instruction); (b) interactive teaching (assess and activate foundation knowledge before teaching; teach to explicit learning objectives; model skills to be learned; frequently monitor student comprehension as material is presented; re-teach material when necessary); and (c) cooperative learning (involve small teams of students of different ability levels and backgrounds as learning partners; provide recognition to teams for academic improvement of individual members over past performance). Teacher training was provided to teachers of participants in full intervention classrooms in grades 1 through 6 and to teachers of participants in late intervention classrooms in grades 5 and 6.
Child Social and Emotional Skill Development included instruction in (a) interpersonal problem solving skills (communication; decision making; negotiation; conflict resolution) provided by teachers in classrooms assigned to the full intervention condition in grades 1 and 2; and (b) refusal skills (recognize social influences to engage in problem behaviors; identify consequences of problem behaviors; generate and suggest alternatives; invite peer(s) to join in alternatives) provided to participants in both the full intervention condition and the late intervention condition in grades 5 and 6.
Parent Training offered to parents of participants in the full intervention condition included instruction in (a) behavior management skills (observe and pinpoint desirable and undesirable child behaviors; teach expectations for behaviors; provide consistent positive reinforcement for desired behavior; provide consistent and moderate consequences for undesired behaviors) when participants were in grades 1 and 2; (b) academic support skills (initiate conversation with teachers about children's learning; help children develop reading and math skills; create a home environment supporting of learning) when participants were in grades 2 and 3; and (c) skills to reduce risks for drug use (establish a family policy on drug use; practice refusal skills with children; use self-control skills to reduce family conflict; create new opportunities in the family for children to contribute and learn) when participants were in grades 5 and 6. Parent training in skills to reduce risks for drug use was also offered to parents of participants in the late intervention condition and the parenting only condition when participants were in grades 5 and 6.
This resulted in a nonrandomized controlled trial with 4 conditions. The full intervention group received the intervention package from grade 1 through grade 6. The late intervention group received the intervention package in grades 5 and 6 only. The parent intervention only condition included students in schools assigned to receive only parent training in skills to reduce risks for drug use when their children were in grades 5 and 6, and the control group received no special intervention. This design was created in 1985 by nesting an intervention initiated in 1981 at first-grade entry within the clinical trial. For the present study, schools were assigned nonrandomly to conditions in the fall of 1985, and from that point, all fifth-grade students in the full and late intervention conditions participated in the same interventions. New schools added for the clinical trial when students entered grade 5 were matched to the original intervention and control schools with respect to grades served and inclusion of students drawn from high-crime neighborhoods of Seattle. Schools added for the panel study were assigned to conditions to achieve balanced numbers across conditions. During this study the Seattle School District used mandatory busing to achieve racial equality in schools. As a result, all schools in this study served heterogeneous population of students drawn from at least 2 different neighborhoods of the city. This practice reduced the risk that outcomes observed in the trial reflected contextual or neighborhood differences in the populations attending different schools.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All students enrolled in the fifth grade in 1985 in one of 18 Seattle public elementary schools selected for the study were eligible
- Eligible schools had to serve children from neighborhoods with above average crime rates
- Parents of eligible participants consented to their longitudinal participation
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: full intervention
students assigned to intervention classrooms in grades 1 through 4 and who remained in schools assigned to the intervention condition in grades 5 or 6
|
Other Names:
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Experimental: late intervention
students in intervention classrooms in grades 5 and 6 only
|
Other Names:
|
Experimental: parent-training only
students whose parents were offered parent training only when their children were in grades 5 and 6 and no other intervention
|
Other Names:
|
No Intervention: control
students in schools assigned to receive no intervention in grades 5 and 6 and who were not in intervention classrooms in grades 1 through 4
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
substance use
Time Frame: annually at ages 10 through 16 and again at age 18 (1985 through 1991 and in 1993)
|
Youth substance use was assessed by having all study participants complete standardized survey instruments from the University of Michigan Monitoring the Future survey annually from ages 10 to 16 and again at age 18, designed to assess children's substance use.
Items from surveys were combined into scales assessing youth self-reported onset and use of specific substances in the year and 30 day period prior to each survey administration.
|
annually at ages 10 through 16 and again at age 18 (1985 through 1991 and in 1993)
|
delinquency
Time Frame: annually at ages 10 through 16 and again at age 18 (1985 through 1991 and in 1993)
|
Youth delinquency was assessed by having all study participants complete standardized survey instruments from the University of Colorado National Youth Survey annually from ages 10 to 16 and again at age 18, designed to assess children's delinquent behavior.
Items from surveys were combined into scales assessing youth onset of delinquency and number of different delinquent acts self-reported by youth for the year prior to each survey administration..
|
annually at ages 10 through 16 and again at age 18 (1985 through 1991 and in 1993)
|
school misbehavior
Time Frame: annually at ages 10 through 16 and again at age 18 (1985 through 1991 and in 1993)
|
Youth school misbehavior was assessed by having all study participants complete standardized survey instruments annually from ages 10 to 16 and again at age 18, designed to assess children's behavioral outcomes.
Teachers completed the Teacher Report Form of the Child Behavior Checklist, a standardized instrument developed to measure children's behaviors, annually from ages 11 to 14. Items from surveys were combined into scales assessing youths' self-reported onset and involvement in misbehavior at school and teacher reported involvement of the participant in misbehavior at school in the year prior to each survey administration.
|
annually at ages 10 through 16 and again at age 18 (1985 through 1991 and in 1993)
|
aggression and violence
Time Frame: annually at ages 10 through 16 and again at age 18 (1985 through 1991 and in 1993)
|
Youth aggression and violence was assessed by having all study participants complete standardized survey instruments annually from ages 10 to 16 and again at age 18, designed to assess children's behavioral outcomes.
Teachers completed the Teacher Report Form of the Child Behavior Checklist, a standardized instrument developed to measure children's behaviors, annually from ages 11 to 14. Items from surveys were combined into scales assessing youths' self-reported onset and involvement in aggressive and violent behavior and teacher reported involvement of the participant in aggressive and violent behavior in the year prior to each survey administration.
|
annually at ages 10 through 16 and again at age 18 (1985 through 1991 and in 1993)
|
school achievement
Time Frame: annually at ages 10 through 16 and again at age 18 (1985 through 1991 and in 1993)
|
Youth school achievement was assessed by having all study participants complete standardized survey instruments annually from ages 10 to 16 and again at age 18, designed to assess children's behavioral outcomes.
Teachers completed the Teacher Report Form of the Child Behavior Checklist, a standardized instrument developed to measure children's behaviors, annually from ages 11 to 14. Items from surveys were combined into scales assessing youths' self-reported level of achievement at school and teacher reported level of participant achievement in the year prior to each survey administration.
|
annually at ages 10 through 16 and again at age 18 (1985 through 1991 and in 1993)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: J. David Hawkins, PhD, University of Washington
Publications and helpful links
General Publications
- Hawkins JD, Von Cleve E, Catalano RF Jr. Reducing early childhood aggression: results of a primary prevention program. J Am Acad Child Adolesc Psychiatry. 1991 Mar;30(2):208-17. doi: 10.1097/00004583-199103000-00008.
- Hawkins JD, Catalano RF, Morrison DM, O'Donnell J, Abbott RD, Day LE, McCord J, Tremblay RE. The Seattle Social Development Project: Effects of the first four years on protective factors and problem behaviors. In: McCord J, Tremblay, RE, editors. Preventing antisocial behavior: Interventions from birth through adolescence. New York: Guilford Press; 1992. 139-61.
- O'Donnell J, Hawkins JD, Catalano RF, Abbott RD, Day LE. Preventing school failure, drug use, and delinquency among low-income children: long-term intervention in elementary schools. Am J Orthopsychiatry. 1995 Jan;65(1):87-100. doi: 10.1037/h0079598.
- Abbott RD, O'Donnell J, Hawkins JD, Hill KG, Kosterman R, Catalano RF. Changing teaching practices to promote achievement and bonding to school. Am J Orthopsychiatry. 1998 Oct;68(4):542-52. doi: 10.1037/h0080363.
- Hill KG, Bailey JA, Steeger CM, Hawkins JD, Catalano RF, Kosterman R, Epstein M, Abbott RD. Outcomes of Childhood Preventive Intervention Across 2 Generations: A Nonrandomized Controlled Trial. JAMA Pediatr. 2020 Aug 1;174(8):764-771. doi: 10.1001/jamapediatrics.2020.1310.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY 22-355
- R01DA003721 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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