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Clinical Trials/NCT01098695
NCT01098695
Completed
Not Applicable

Early Family-Centered Prevention of Drug Use Risk

University of Oregon3 sites in 1 country731 target enrollmentMarch 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Use
Sponsor
University of Oregon
Enrollment
731
Locations
3
Primary Endpoint
Home visit assessment
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The investigators are testing the efficacy of a family-based preventive intervention, which began when the children were age 2, with children at risk for developing significant conduct problems. Families who were originally recruited from Women, Infants and Children (WIC) were randomly assigned to a family-centered intervention developed by Dishion and colleagues (Dishion & Kavanagh, 2003; Dishion & Stormshak, 2006) referred to as an 'ecological approach to family intervention and treatment' (EcoFIT). The current study expands the Early Steps intervention into the elementary school years beyond what is currently available for a WIC service delivery venue, in which children are no longer eligible for services at age 6.

The investigators are testing the hypothesis that periodic, tailored, and adaptive interventions delivered to caregivers at school entry will (a) reduce the probability of elevated risk associated with early-onset problem behavior, including the eventual use of drugs and other health-risking behaviors; (b) reduce the likelihood of mental health problems such as childhood depression, anxiety, conduct problems and co-morbidity; and (c) promote children's development of self-regulation, which underlies school readiness, early school literacy academic achievement, and positive peer relations.

Detailed Description

Aims of the current project are: 1. Refine the intervention model to address the child's adaptation to school and development of self-regulatory skills and underlying multiple dimensions of school success. 2. Examine and test the consistency of developmental models of problem behavior, emotional adjustment, and normative self-regulation in childhood. 3. Evaluate the long-term impact of intervention on risk pathways to later drug abuse and health-risking behaviors by examining early risk markers, including children's problem behavior, poor emotional adjustment, and lack of school readiness.

Registry
clinicaltrials.gov
Start Date
March 2003
End Date
November 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Parents with children between ages two and three
  • Currently enrolled with Women, Infants, and Children (WIC)
  • To qualify for the original study, families needed to meet criteria for child, family, and sociodemographic risk. Specifically, families either had to meet "child risk" factors or they had to have at least two of the three factors present to qualify for the study. To meet criterion for child risk, scores must be at least one SD above the normative average on the Eyberg Intensity of Problems factors, the Bates difficulty (i.e. negative emotionality) factor, or the conflict factor of the Adult-Child Relationship Scale. Family risk was determined by a score of one SD above the normative average on maternal depressive symptoms or parenting daily hassles, having substance use/abuse problems, or teen parent status. Sociodemographic risk was established using educational attainment because all WIC participants met criteria for low income. Families in which educational attainment is less than three years of college for both parents satisfied the requirement of sociodemographic risk.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Home visit assessment

Time Frame: yearly

Includes caregiver assessment packets (including CBCL, Eyberg, Rothbart Effortful Control scales, CESD-D, parental substance use, Adult-Child Relationship scale), child assessment (including DIBELS and Woodcock-Johnson) and Parent-Child videotaped interactions.

Study Sites (3)

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