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

Sponsor

University of Oregon (Other)

Overall Status

Completed

CT.gov ID

NCT01098695

Collaborator

University of Pittsburgh (Other), University of Virginia (Other)

731

Enrollment

Locations

Arms

152

Duration (Months)

243.7

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Use Conduct Disorder Depression Anxiety	Other: Ecological Family Intervention and Treatment (EcoFIT)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

731 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Early Family-Centered Prevention of Drug Use Risk

Study Start Date :

Mar 1, 2003

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EcoFIT offered	Other: Ecological Family Intervention and Treatment (EcoFIT) 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)
No Intervention: No Feedback or services offered

Arm

Intervention/Treatment

Experimental: EcoFIT offered

Other: Ecological Family Intervention and Treatment (EcoFIT)

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)

No Intervention: No Feedback or services offered

Outcome Measures

Primary Outcome Measures

Home visit assessment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 3 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Oregon-Child and Family Center	Eugene	Oregon	United States	97401
2	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15260
3	University of Virginia	Charlottesville	Virginia	United States	22904