Systematically Adapted Delivery of the Family Check-Up

NCT02709291 | Completed

• 1 other identifier: R34MH106661
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenting, Child Behavior, Implementation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Feasibility: Number of sessions completed

  2 weeks after final parent-child dyad completes the study

• Feasibility: Interventionist-reported fidelity

  following each behavioral parent training intervention session

• Feasibility: Parent satisfaction

  10 weeks after parent baseline

• Interventionist satisfaction

  2 weeks after final parent-child dyad completes study

• Interventionist evidence-based practice attitudes

  2 weeks after final parent-child dyad completes study

Other Outcomes (6)

• Feasibility: Observer-rated fidelity

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

• Costs: Training

  2 weeks after final parent-child dyad completes study

• Costs: Per-family interventionist time

  2 weeks after final parent-child dyad completes study

Study Arms (2)

Community Health Workers

OTHER

Community health workers will complete a 5-day interventionist training to deliver a behavioral parent training intervention.

Behavioral: interventionist training

Parent-Child Dyads

OTHER

Parents and children will receive a behavioral parent training intervention delivered by community health workers.

Behavioral: behavioral parent training

Interventions

behavioral parent training BEHAVIORAL

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

Parent-Child Dyads

interventionist training BEHAVIORAL

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

Community Health Workers

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christina Studts: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Kentuckyi

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Christina R Studts, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 16, 2016
• Study Start: February 20, 2017
• Primary Completion: May 16, 2018
• Study Completion: June 26, 2018
• Last Updated: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)