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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02289092
Other study ID # 05142014.022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date June 30, 2019

Study information

Verified date June 2022
Source University of Oregon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 848
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 700 Kindergarten children and their families entering Kindergarten in the Clackamas School District in 2014 and 2015 - Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Family Check-Up
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).

Locations

Country Name City State
United States University of Oregon Child and Family Center Eugene Oregon

Sponsors (1)

Lead Sponsor Collaborator
University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in parenting skills measured by standardized questionnaires Change in parenting skills for parents participating in the intervention arm measured by standardized questionnaires Up to 3 years
Primary Change in child self-regulation and behavioral control measured by standardized questionnaires 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 Up to 3 years
Primary Increase chances for child school success as measured by early literacy standardized testing scores 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 Up to 3 years
Primary Increase positive child social relationships as measured by standardized questionnaires Increase positive social relationships in child participating in the intervention arm in comparison with children in the control arm as measured by standardized questionnaires Up to 3 years
Secondary Decrease in family stress/hardship as measured by standardized questionnaires Decrease in family stress and or hardship for families participating in the intervention arm as measured by standardized questionnaires Up to 3 years
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