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Early Family-Centered Prevention of Drug Use Risk (Aka Early Steps) (Early Steps)

Primary Purpose

Substance Use, Conduct Disorder, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ecological Family Intervention and Treatment (EcoFIT)
Sponsored by
University of Oregon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use focused on measuring parenting interventions, Family Check-Up, Early Intervention, Self-Regulation

Eligibility Criteria

2 Years - 3 Years (Child)All SexesDoes not accept healthy volunteers

Original 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.

Sites / Locations

  • University of Oregon-Child and Family Center
  • University of Pittsburgh
  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EcoFIT offered

No Feedback or services offered

Arm Description

Outcomes

Primary Outcome Measures

Home visit assessment
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.

Secondary Outcome Measures

Full Information

First Posted
April 1, 2010
Last Updated
January 17, 2019
Sponsor
University of Oregon
Collaborators
University of Pittsburgh, University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT01098695
Brief Title
Early Family-Centered Prevention of Drug Use Risk (Aka Early Steps)
Acronym
Early Steps
Official Title
Early Family-Centered Prevention of Drug Use Risk
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oregon
Collaborators
University of Pittsburgh, University of Virginia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. Examine and test the consistency of developmental models of problem behavior, emotional adjustment, and normative self-regulation in childhood. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Conduct Disorder, Depression, Anxiety
Keywords
parenting interventions, Family Check-Up, Early Intervention, Self-Regulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
731 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EcoFIT offered
Arm Type
Experimental
Arm Title
No Feedback or services offered
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Ecological Family Intervention and Treatment (EcoFIT)
Other Intervention Name(s)
Family Check-Up (FCU)
Intervention Description
Includes the Family Check-Up (in-person intake, family video observations and Assessment questionnaires used to provide and tailored feedback using motivational interviewing techniques) as well as continued tailored intervention services using the Everyday Parenting Curriculum.
Primary Outcome Measure Information:
Title
Home visit assessment
Description
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.
Time Frame
yearly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Original 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Dishion, PhD
Organizational Affiliation
University of Oregon- Child and Family Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oregon-Child and Family Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cfc.uoregon.edu
Description
Child and Family Center Website

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Early Family-Centered Prevention of Drug Use Risk (Aka Early Steps)

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