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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Substance Use Anxiety Anxiety Disorders Attention Deficit and Disruptive Behavior Disorders Behavior Behavioral Symptoms Chemically-Induced Disorders Conduct Disorder Depression Mental Disorders Neurodevelopmental Disorders Self-Control Social Behavior Substance-Related Disorders

Age range

2 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oregon-Child and Family Center, Eugene, Oregon, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ecological Family Intervention and Treatment (EcoFIT)

Other

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.

Other names: Family Check-Up (FCU)

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.

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Collaborators

University of Pittsburgh
University of Virginia

Registry information

Official study title

Early Family-Centered Prevention of Drug Use Risk

Acronym: Early Steps

Important dates

Study start: 2003
Primary completion: 2015
Study completion: 2015
First posted: Apr 5, 2010
Registry last updated: Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed