Substance UseEarly StepsNCT01098695
Early Family-Centered Prevention of Drug Use Risk (Aka Early Steps)
A study testing Ecological Family Intervention and Treatment (EcoFIT) in people with Substance Use and Conduct Disorder, run by University of Oregon at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 3 years
- Conditions the study is for
- Substance Use, Conduct Disorder, Depression
- What is being tested?
- Ecological Family Intervention and Treatment (EcoFIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 731 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2003to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 3 years
- All sexes
- No healthy volunteers
- Child
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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Virginia
Charlottesville, Virginia, 22904
University of Oregon-Child and Family Center
Eugene, Oregon, 97401
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Early Family-Centered Prevention of Drug Use Risk
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.
Read the 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.
- Conditions
- Substance Use, Conduct Disorder, Depression, Anxiety
- Being tested
- Ecological Family Intervention and Treatment (EcoFIT)
- Keywords
- parenting interventions, Family Check-Up, Early Intervention, Self-Regulation
- Medical subject headings
- Substance-Related Disorders, Conduct Disorder, Depression, Anxiety Disorders, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological Family Intervention and Treatment (EcoFIT)Other
Also called Family Check-Up (FCU)
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.
| Study group | Role | What they receive |
|---|---|---|
| EcoFIT offered | Experimental | Not described Receives: Other: Ecological Family Intervention and Treatment (EcoFIT) |
| No Feedback or services offered | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2010 (estimated)
- Study startMar 2003
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, University of Virginia
- Responsible party
- Sponsor
- Investigators
- Thomas J Dishion, PhD, Principal investigator, University of Oregon- Child and Family Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098695
- Sponsor's protocol ID
- 3R01DA016110
- Acronym
- Early Steps
- Status last verified
- Jan 2019
- First submitted
- 1 Apr 2010
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Family-Centered Prevention of Drug Use Risk
- ClinicalTrials.gov ID
- NCT01098695
- Acronym / sponsor ID
- Early Steps / 3R01DA016110
- Conditions
- Substance Use, Conduct Disorder, Depression, Anxiety
- Keywords
- parenting interventions, Family Check-Up, Early Intervention, Self-Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- University of Pittsburgh, University of Virginia
- Study start
- Mar 2003
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EcoFIT offered | Experimental | Other: Ecological Family Intervention and Treatment (EcoFIT) |
| No Feedback or services offered | No intervention | – |
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecological Family Intervention and Treatment (EcoFIT)Also: Family Check-Up (FCU)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 | EcoFIT offered |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
Related trials for Substance Use
RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J Dishion, PhD principal investigator
University of Oregon- Child and Family Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecological Family Intervention and Treatment (EcoFIT) in people with Substance Use and Conduct Disorder, run by University of Oregon at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home visit assessment (time frame: yearly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.