Clinical trial NCT04459845: Early Intervention For Families Experiencing Homelessness: A Randomized Trial Comparing Two Parenting Programs
Official title: Early Intervention For Families Experiencing Homelessness: A Randomized Trial Comparing Two Parenting Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior Problem
Parenting
Keywords: early intervention
parenting
homelessness
parent child interaction therapy
child parent psychotherapy
behavior problems
trauma symptoms
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: Lotus House
First posted: 2020-07-07
Enrollment: 144
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the efficacy in delivering two evidence-based parenting programs to families and young children experiencing homelessness. Outcomes evaluated include feasibility, treatment completion, treatment satisfaction of delivery of interventions as well as child outcomes (e.g., behavior problems, trauma symptoms) and parenting outcomes (parenting stress and parenting skills).

Detailed description: The number of homeless families in the U.S. has increased since the 1980s to over half a million as of 2018. Most troubling, in 2013 (the most recent year for which census data is available) one in every 30 children in the U.S., or 2.5 million, experienced homelessness. In addition to having disproportionally higher rates of unmet health needs (e.g., acute health problems, trauma-related injuries), children experiencing homelessness have staggering mental health needs such that 78% suffer from at least one mental health issue (e.g., depression, behavior problems) along with academic/developmental delays. Given that over half of all homeless children in the US are under the age of 6, it is particularly important to investigate the effectiveness of evidence-based parenting programs within a homeless population. This study aims to compare the efficacy in delivering two evidence-based parenting programs to families and young children experiencing homelessness.

Eligibility criteria: Inclusion Criteria:

* Any child between the ages of 2 and 5 and his/her mother who is currently homeless and living in the Lotus House shelter.

Exclusion Criteria:

* Family is already involved in a parenting program or does not speak English or Spanish.

Primary outcomes:
measure: Eyberg Child Behavior Inventory (ECBI)
timeFrame: 16 weeks after start of intervention
measure: Child and Adolescent Trauma Screener (CATS)
timeFrame: 16 weeks after start of intervention
measure: Parenting Stress Index Short Form 4th edition (PSI-SF)
timeFrame: 16 weeks after start of intervention
measure: The Dyadic Parent-Child Interaction Coding System
timeFrame: 16 weeks after start of intervention
Secondary outcomes:
measure: Therapy Attitude Inventory
timeFrame: 16 weeks after start of intervention
measure: Treatment Attendance
timeFrame: 16 weeks after start of intervention
Other outcomes:
Locations:
city: Miami
country: United States
facility: Lotus House
state: Florida
Study officials:
affiliation: Florida International University
name: Paulo Graziano, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: