The Seattle Social Development Project: An Implementation of the Raising Healthy Children Intervention (SSDP)
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| ClinicalTrials.gov Identifier: NCT04075019 |
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Recruitment Status :
Completed
First Posted : August 30, 2019
Last Update Posted : September 3, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Adolescent Health Adolescent Problem Behavior | Behavioral: The Raising Healthy Children intervention, including teacher training, child skill development, and parent training | Not Applicable |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 808 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Factorial Assignment |
| 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Start Date : | September 1, 1981 |
| Actual Primary Completion Date : | June 13, 1987 |
| Actual Study Completion Date : | June 30, 1993 |
| Arm | Intervention/treatment |
|---|---|
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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
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Behavioral: The Raising Healthy Children intervention, including teacher training, child skill development, and parent training
Other Name: Seattle Social Development Project |
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Experimental: late intervention
students in intervention classrooms in grades 5 and 6 only
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Behavioral: The Raising Healthy Children intervention, including teacher training, child skill development, and parent training
Other Name: Seattle Social Development Project |
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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
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Behavioral: The Raising Healthy Children intervention, including teacher training, child skill development, and parent training
Other Name: Seattle Social Development Project |
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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
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- 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.
- 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..
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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:
-
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075019
| Principal Investigator: | J. David Hawkins, PhD | University of Washington |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | J. David Hawkins, Professor, School of Social Work, and Director, Social Development Research Group, University of Washington |
| ClinicalTrials.gov Identifier: | NCT04075019 |
| Other Study ID Numbers: |
STUDY 22-355 R01DA003721 ( U.S. NIH Grant/Contract ) |
| First Posted: | August 30, 2019 Key Record Dates |
| Last Update Posted: | September 3, 2019 |
| Last Verified: | August 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Selected, de-identified data are shared with collaborating colleagues at other institutions. Shared datasets contain variable subsets related to analyses planned for developing papers for publication. |
| Supporting Materials: |
Study Protocol |
| Time Frame: | Data first became available in 1986 and are available on an ongoing basis. |
| Access Criteria: | Selected, de-identified data are shared with collaborating colleagues at other institutions after obtaining signed "fair use" and confidentiality agreements from the collaborator wherein they agree to work with the study PIs and abide by study-related human subjects and consent agreements, and data security procedures. Shared datasets are to be used for analyses planned for developing papers for publication. The PI is responsible for obtaining signed agreements and reviewing and approving data sharing requests. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |
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Problem Behavior Behavioral Symptoms |

