Systematically Adapted Delivery of the Family Check-Up

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

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.

Study Overview

• Status: Completed
• Conditions: Parenting, Child Behavior, Implementation
• Intervention / Treatment: Behavioral: interventionist training; Behavioral: behavioral parent training

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentuckyi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Community Health Workers; Community health workers will complete a 5-day interventionist training to deliver a behavioral parent training intervention.	Behavioral: interventionist training; Interventionists are trained in the delivery of the Family Check-Up program and deliver sessions to families in their community
Other: Parent-Child Dyads; Parents and children will receive a behavioral parent training intervention delivered by community health workers.	Behavioral: behavioral parent training; Parents receive up to 6 sessions of the Family Check-Up program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Enrollment	Percentage of invited parents who enroll in the study (obtained from process records)	2 weeks after final parent-child dyad completes the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Number of sessions completed	Number of sessions completed by each parent-child dyad (obtained from process records)	2 weeks after final parent-child dyad completes the study
Feasibility: Interventionist-reported fidelity	Fidelity Checklist (completed by community health workers)	following each behavioral parent training intervention session
Feasibility: Parent satisfaction	European Parent Satisfaction Scale about Early Intervention (EPASSEI) (completed by parents)	10 weeks after parent baseline
Interventionist satisfaction	Therapist Satisfaction Index (completed by community health workers)	2 weeks after final parent-child dyad completes study
Interventionist evidence-based practice attitudes	Evidence-Based Practice Attitude Scale-50 (completed by community health workers)	2 weeks after final parent-child dyad completes study
Interventionist self-efficacy	Counselor Activity Self-Efficacy Scale (completed by community health workers)	2 weeks after final parent-child dyad completes study

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Observer-rated fidelity	Family Check-Up COACH fidelity rating system (observer-rated videos of 10% of intervention sessions)	Throughout 10 weeks of behavioral parent training intervention per parent-child dyad
Costs: Training	Total costs of training (obtained from process records maintained by investigators)	2 weeks after final parent-child dyad completes study
Costs: Per-family interventionist time	Obtained from process records maintained by community health workers	2 weeks after final parent-child dyad completes study
Costs: Per-family interventionist travel	Obtained from process records maintained by community health workers	2 weeks after final parent-child dyad completes study
Costs: Supervision time	Obtained from process records maintained by community health workers	2 weeks after final parent-child dyad completes study
Costs: Number of contacts outside of intervention sessions	Obtained from process records maintained by community health workers	2 weeks after final parent-child dyad completes study

Collaborators and Investigators

• Sponsor: Christina Studts
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Christina R Studts, PhD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Actual): May 16, 2018
• Study Completion (Actual): June 26, 2018

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: March 10, 2016
• First Posted (Estimate): March 16, 2016

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: March 31, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: R34MH106661 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No