NCT02289092

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
848

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

4.8 years

First QC Date

October 14, 2014

Last Update Submit

June 16, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Decrease in family stress/hardship as measured by standardized questionnaires

    Up to 3 years

Study Arms (2)

Family Check-Up Intervention

EXPERIMENTAL

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).

Behavioral: Family Check-Up

Control

NO INTERVENTION

Control families will receive services as usual that are being provided to the families within their school

Interventions

Family Check-UpBEHAVIORAL

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).

Also known as: Positive Family Support
Family Check-Up Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oregon Child and Family Center

Eugene, Oregon, 97403, United States

Location

Related Publications (5)

  • Hails KA, McWhirter AC, Garbacz SA, DeGarmo D, Caruthers AS, Stormshak EA, McIntyre LL. Parenting self-efficacy in relation to the family check-up's effect on elementary school children's behavior. J Fam Psychol. 2024 Sep;38(6):858-868. doi: 10.1037/fam0001237. Epub 2024 May 23.

  • Flack CE, Garbacz SA, Stormshak EA, McIntyre LL. A longitudinal study of home-based involvement and dyadic adjustment during the transition to early elementary school. Sch Psychol. 2023 Sep;38(5):287-293. doi: 10.1037/spq0000543. Epub 2023 Mar 30.

  • Resnik F, Garbacz SA, Stormshak EA, McIntyre LL. Family-centered prevention to enhance proactive parenting and parental self-efficacy during early elementary school. J Fam Psychol. 2023 Apr;37(3):380-387. doi: 10.1037/fam0001050. Epub 2023 Jan 9.

  • 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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2014

First Posted

November 13, 2014

Study Start

September 1, 2014

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations