Clinical trial NCT02709291: Systematically Adapted Delivery of the Family Check-Up
Official title: Systematically Adapted Delivery of the Family Check-Up in Underserved Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting, Child Behavior, Implementation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2016-03-16
Enrollment: 51
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: Enrollment
timeFrame: 2 weeks after final parent-child dyad completes the study
Secondary outcomes:
measure: Feasibility: Number of sessions completed
timeFrame: 2 weeks after final parent-child dyad completes the study
measure: Feasibility: Interventionist-reported fidelity
timeFrame: following each behavioral parent training intervention session
measure: Feasibility: Parent satisfaction
timeFrame: 10 weeks after parent baseline
measure: Interventionist satisfaction
timeFrame: 2 weeks after final parent-child dyad completes study
measure: Interventionist evidence-based practice attitudes
timeFrame: 2 weeks after final parent-child dyad completes study
measure: Interventionist self-efficacy
timeFrame: 2 weeks after final parent-child dyad completes study
Other outcomes:
measure: Feasibility: Observer-rated fidelity
timeFrame: Throughout 10 weeks of behavioral parent training intervention per parent-child dyad
measure: Costs: Training
timeFrame: 2 weeks after final parent-child dyad completes study
measure: Costs: Per-family interventionist time
timeFrame: 2 weeks after final parent-child dyad completes study
measure: Costs: Per-family interventionist travel
timeFrame: 2 weeks after final parent-child dyad completes study
measure: Costs: Supervision time
timeFrame: 2 weeks after final parent-child dyad completes study
measure: Costs: Number of contacts outside of intervention sessions
timeFrame: 2 weeks after final parent-child dyad completes study
Locations:
city: Lexington
country: United States
facility: University of Kentuckyi
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Christina R Studts, PhD
role: PRINCIPAL_INVESTIGATOR
References: