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AchievementNCT02289092

The Positive Family Support Project - Partnering With Families for a Successful Transition to School

A study testing Family Check-Up in people with Achievement, run by University of Oregon at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Achievement
What is being tested?
Family Check-Up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
848 participants
Where
1 siteUnited States
Study dates
Sep 2014to 30 Jun 2019
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Oregon Child and Family Center

    Eugene, Oregon, 97403

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Achievement
Being tested
Family Check-Up

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family Check-UpBehavioural

    Also called Positive Family Support

    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).

Study groups in NCT02289092
Study groupRoleWhat they receive
Family Check-Up InterventionExperimentalPrior 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).
Receives: Behavioral: Family Check-Up
ControlNo interventionControl families will receive services as usual that are being provided to the families within their school

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in parenting skills measured by standardized questionnaires

    Change in parenting skills for parents participating in the intervention arm measured by standardized questionnaires

    Measured: Up to 3 years

  2. 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

    Measured: Up to 3 years

  3. 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

    Measured: Up to 3 years

  4. 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

    Measured: Up to 3 years

Secondary outcomes (1)

  1. 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

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2014 (estimated)
  2. Study startSep 2014
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2019

Resources

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
Single group
Masking
None (open label)
Enrolment
848 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02289092
Sponsor's protocol ID
05142014.022
Status last verified
Jun 2022
First submitted
14 Oct 2014
Last updated
21 Jun 2022
Results posted
No
Data monitoring committee
No

Publications

  • Flack CE, Garbacz SA, Stormshak EA, McIntyre LL. The family check-up: Relations between motivational interviewing fidelity and intervention outcomes in early elementary school. Sch Psychol. 2026 Sep;41(5):545-555. doi: 10.1037/spq0000744. Epub 2026 Mar 26.

    PubMed 41885896

  • 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.

    PubMed 38780604

  • 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.

    PubMed 36996236

  • 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.

    PubMed 36622726

  • 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.

    PubMed 32036553

  • 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.

    PubMed 31318264

Questions about this trial

What is this clinical trial studying?

A study testing Family Check-Up in people with Achievement, run by University of Oregon at 1 site 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?

The sponsor lists 0 inclusion and 1 exclusion criteria. 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 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Change in parenting skills measured by standardized questionnaires (time frame: Up to 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02289092, which also lists 6 linked publications.

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 21 Jun 2022.

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