Skip to main content
OpenTrials
Completed

NCT Number: NCT02709291

Systematically Adapted Delivery of the Family Check-Up

Early childhood disruptive behavior problems lead to significant costs to families and society, but can be reduced with behavioral parent training interventions. To increase the public health impact of these interventions, their feasibility, accessibility, and acceptability in high-need, underserved communities must be ensured. This pilot project will systematically adapt and pilot-test the delivery model of an existing effective parent training intervention for implementation in rural Appalachia, a region with many documented health disparities, high levels of poverty, and shortages of mental health providers. Community health workers in 5 rural Appalachian counties will be trained to deliver a behavioral parent training intervention. Each worker will deliver the intervention to 4 parent-child dyads.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parenting, Child Behavior, Implementation Behavior Child Behavior

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentuckyi

Lexington, Kentucky, 40506, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parents: aged 18+ years, custodial guardian of child, can speak/read/understand English
  • Children: ages 3-5 years, lives full time in custodial guardian's home
  • Community health workers: aged 18+ years, currently employed at a partnering health department, able to speak/read/understand English

Exclusion criteria

  • Parents: has already accessed behavioral health services for the child, reports suicidal ideation or intent to harm self or others, participated in formative research for this study
  • Children: diagnosed with a severe developmental condition (i.e., significant developmental delay, autism, debilitating neurological condition)
  • Community health workers: none

Treatment and study plan

Behavioral Parent Training

Behavioral

Parents receive up to 6 sessions of the Family Check-Up program

interventionist training

Behavioral

Interventionists are trained in the delivery of the Family Check-Up program and deliver sessions to families in their community

Primary outcomes

  1. Feasibility: Enrollment

    Time frame: 2 weeks after final parent-child dyad completes the study

    Percentage of invited parents who enroll in the study (obtained from process records)

Secondary outcomes

  1. Feasibility: Number of sessions completed

    Time frame: 2 weeks after final parent-child dyad completes the study

    Number of sessions completed by each parent-child dyad (obtained from process records)

  2. Feasibility: Interventionist-reported fidelity

    Time frame: following each behavioral parent training intervention session

    Fidelity Checklist (completed by community health workers)

  3. Feasibility: Parent satisfaction

    Time frame: 10 weeks after parent baseline

    European Parent Satisfaction Scale about Early Intervention (EPASSEI) (completed by parents)

  4. Interventionist satisfaction

    Time frame: 2 weeks after final parent-child dyad completes study

    Therapist Satisfaction Index (completed by community health workers)

  5. Interventionist evidence-based practice attitudes

    Time frame: 2 weeks after final parent-child dyad completes study

    Evidence-Based Practice Attitude Scale-50 (completed by community health workers)

  6. Interventionist self-efficacy

    Time frame: 2 weeks after final parent-child dyad completes study

    Counselor Activity Self-Efficacy Scale (completed by community health workers)

Other outcomes

  1. Feasibility: Observer-rated fidelity

    Time frame: Throughout 10 weeks of behavioral parent training intervention per parent-child dyad

    Family Check-Up COACH fidelity rating system (observer-rated videos of 10% of intervention sessions)

  2. Costs: Training

    Time frame: 2 weeks after final parent-child dyad completes study

    Total costs of training (obtained from process records maintained by investigators)

  3. Costs: Per-family interventionist time

    Time frame: 2 weeks after final parent-child dyad completes study

    Obtained from process records maintained by community health workers

  4. Costs: Per-family interventionist travel

    Time frame: 2 weeks after final parent-child dyad completes study

    Obtained from process records maintained by community health workers

  5. Costs: Supervision time

    Time frame: 2 weeks after final parent-child dyad completes study

    Obtained from process records maintained by community health workers

  6. Costs: Number of contacts outside of intervention sessions

    Time frame: 2 weeks after final parent-child dyad completes study

    Obtained from process records maintained by community health workers

Sponsors and collaborators

Lead sponsor

Christina Studts

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Systematically Adapted Delivery of the Family Check-Up in Underserved Communities

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 16, 2016
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.