- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02289092
The Positive Family Support Project - Partnering With Families for a Successful Transition to School
June 16, 2022 updated by: Beth Stormshak, University of Oregon
Testing the Efficacy of an Ecological Approach to Family Intervention and Treatment During Early Elementary School to Prevent Problem Behavior and Improve Academic Outcomes
The Positive Family Support Project seeks to understand some of the factors that increase success for children in early elementary school, such as positive family support at home.
This study will inform us on ways to help children learn and succeed in school.
Study Overview
Detailed Description
The transition to elementary school is a critical time for the development of key skills that are necessary for school success, including sustained attention, self-regulation, initiating and sustaining successful peer relationships, and academic competence.
Parent support at home, such as positive parenting and support for learning, is associated with school readiness indicators that predict successful adaptation to the school context.
For many children at risk for poor developmental outcomes this transition can be difficult and may lead to early academic problems, which in turn may define a trajectory that culminates in more severe forms of problem behavior and learning difficulties.
The purpose of this study is to evaluate the efficacy of implementing the Family Check-Up (FCU), a school-based, ecological approach to family intervention, during the transition into elementary school.
Study Type
Interventional
Enrollment (Actual)
848
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Eugene, Oregon, United States, 97403
- University of Oregon Child and Family Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria: 700 Kindergarten children and their families entering Kindergarten in the Clackamas School District in 2014 and 2015 -
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Family Check-Up Intervention
Prior to the feedback session, trained clinicians will observe family interactions by reviewing the video-taped observations and questionnaires filled out by parents.
Therapists then use this data to inform the intervention process and provide feedback to parents based on norms for this age period.
Feedback sessions will include a discussion of goal attainment and plans to achieve goals, with specific attention to the parent's role in supporting positive behavior.
Options for obtaining goals are based on the literature about empirically supported interventions for this age group and include (a) periodic follow-up and support, (b) brief support for change on a specific topic, and (c) community referral (e.g., substance abuse referral; domestic violence referral; referral for individual therapy for depression; referral for family therapy and support for families in conflict).
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Parents fill out questionnaires about their child and families and then participate in a videotaped interaction with their child.
Clinicians then observe the video and analyze the questionnaires to establish family needs based on supports, stress, parenting, values, and strengths.
Therapists then use this information to inform the intervention process and provide feedback to families with the use of motivational interviewing.
parents identify goals for parenting and/or child behavior and to connect them with resources when needed.
Feedback includes a discussion of goal attainment and plans to achieve goals.
Goal achievement includes options such as (a) periodic follow-up and support, (b) brief support for change on a specific topic, and (c) community referral (e.g., substance abuse referral; domestic violence referral; referral for individual therapy for depression; referral for family therapy and support for families in conflict).
Other Names:
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No Intervention: Control
Control families will receive services as usual that are being provided to the families within their school
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in parenting skills measured by standardized questionnaires
Time Frame: Up to 3 years
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Change in parenting skills for parents participating in the intervention arm measured by standardized questionnaires
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Up to 3 years
|
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Change in child self-regulation and behavioral control measured by standardized questionnaires
Time Frame: Up to 3 years
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Change in child self-regulation in the classroom for children participating in the intervention arm in comparison to children participating in the control arm measured by standardized questionnaires
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Up to 3 years
|
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Increase chances for child school success as measured by early literacy standardized testing scores
Time Frame: Up to 3 years
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Increase chances for success in school for children participating in the intervention arm in comparison to children participating in the control arm as measured by early literacy standardized testing scores
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Up to 3 years
|
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Increase positive child social relationships as measured by standardized questionnaires
Time Frame: Up to 3 years
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Increase positive social relationships in child participating in the intervention arm in comparison with children in the control arm as measured by standardized questionnaires
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Up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decrease in family stress/hardship as measured by standardized questionnaires
Time Frame: Up to 3 years
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Decrease in family stress and or hardship for families participating in the intervention arm as measured by standardized questionnaires
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Up to 3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Stormshak EA, DeGarmo D, Garbacz SA, McIntyre LL, Caruthers A. Using Motivational Interviewing to Improve Parenting Skills and Prevent Problem Behavior During the Transition to Kindergarten. Prev Sci. 2021 Aug;22(6):747-757. doi: 10.1007/s11121-020-01102-w.
- Stormshak EA, McIntyre LL, Garbacz SA, Kosty DB. Family-centered prevention to enhance parenting skills during the transition to elementary school: A randomized trial. J Fam Psychol. 2020 Feb;34(1):122-127. doi: 10.1037/fam0000570. Epub 2019 Jul 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2014
Primary Completion (Actual)
June 30, 2019
Study Completion (Actual)
June 30, 2019
Study Registration Dates
First Submitted
October 14, 2014
First Submitted That Met QC Criteria
November 12, 2014
First Posted (Estimate)
November 13, 2014
Study Record Updates
Last Update Posted (Actual)
June 21, 2022
Last Update Submitted That Met QC Criteria
June 16, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 05142014.022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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