Clinical trial NCT04075019: The Seattle Social Development Project: An Implementation of the Raising Healthy Children Intervention
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Health
Adolescent Problem Behavior
Keywords: Proactive classroom management
Interactive teaching
Cooperative learning
Interpersonal problem solving skills
Refusal skills
Behavior management skills
Academic support skills
Skills to reduce risks for drug use
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-08-30
Enrollment: 808
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This study examined four separate groups, a "full intervention group" exposed to the interventions in grades 1 through 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.
Primary purpose: PREVENTION

Brief summary: The Seattle Social Development Project (SSDP) included a three-part intervention for teachers, parents, and students in grades 1 to 6. It was a universal prevention program that was tested in elementary schools serving children from high crime urban areas. The intervention trained teachers in proactive classroom management, interactive teaching, and cooperative learning. SSDP also offered training to parents in child behavior management, academic support, and skills to reduce risks for drug use. It provided training to children designed to affect interpersonal problem solving and refusal skills. These interventions were designed to reduce risks and increase protection at the individual, peer, family and school levels. The package of interventions was guided theoretically by the social development model. We hypothesized that training teachers to teach and manage their classrooms in ways that promote bonding to school, training parents to manage their families in ways that promote bonding to family and to school, and providing children with training in skills for social interaction would positively affect children's attitudes toward school, behavior at school, and academic achievement. These methods further sought to reduce children's opportunities and rewards for antisocial involvement. We thought that these changes would, in turn, set children on a different developmental trajectory observable in higher school achievement and fewer health-risk behaviors later in adolescence.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: substance use
timeFrame: annually at ages 10 through 16 and again at age 18 (1985 through 1991 and in 1993)
measure: delinquency
timeFrame: annually at ages 10 through 16 and again at age 18 (1985 through 1991 and in 1993)
measure: school misbehavior
timeFrame: annually at ages 10 through 16 and again at age 18 (1985 through 1991 and in 1993)
measure: aggression and violence
timeFrame: annually at ages 10 through 16 and again at age 18 (1985 through 1991 and in 1993)
measure: school achievement
timeFrame: annually at ages 10 through 16 and again at age 18 (1985 through 1991 and in 1993)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: J. David Hawkins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.