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

NCT01098695 | Completed

• 1 other identifier: 3R01DA016110
• Study Type: interventional
• Target: 731
• Locations: 1 country
• Sites: 3

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.

Conditions

Substance Use; Conduct Disorder; Depression; Anxiety

Keywords

parenting interventions; Family Check-Up; Early Intervention; Self-Regulation

Outcome Measures

Primary Outcomes (1)

• 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.

  yearly

Study Arms (2)

EcoFIT offered

EXPERIMENTAL

Other: Ecological Family Intervention and Treatment (EcoFIT)

No Feedback or services offered

NO INTERVENTION

Interventions

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.

Also known as: Family Check-Up (FCU)

EcoFIT offered

Eligibility Criteria

• Age: 2 Years - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Oregon: lead
• University of Pittsburgh: collaborator
• University of Virginia: collaborator

Study Sites (3)

University of Oregon-Child and Family Center

Eugene, Oregon, 97401, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Conduct Disorder; Depression; Anxiety Disorders; Self-Control

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Behavioral Symptoms; Behavior; Social Behavior

Study Officials

• Thomas J Dishion, PhD

  University of Oregon- Child and Family Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 5, 2010
• Study Start: March 1, 2003
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

US (3)