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Clinical Trials/NCT04459845
NCT04459845CompletedNot Applicable

Early Intervention For Families Experiencing Homelessness: A Randomized Trial Comparing Two Parenting Programs

Florida International University1 site in 1 country144 target enrollmentStarted: August 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
144
Locations
1
Primary Endpoint
Parenting Stress Index Short Form 4th edition (PSI-SF)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Masking Description

Investigator and outcomes assessor are masked to the treatment group

Eligibility Criteria

Ages
2 Years to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Parent Child Interaction Therapy

Active Comparator

Parents and children will receive 12 weekly sessions of PCIT.

Intervention: Parent Child Interaction Therapy (Behavioral)

Child Parent Psychotherapy

Active Comparator

Parents and children will receive 12 weekly sessions of CPP

Intervention: Child Parent Psychotherapy (Behavioral)

Outcomes

Primary Outcomes

Parenting Stress Index Short Form 4th edition (PSI-SF)

Time Frame: 16 weeks after start of intervention

Change in overall level of parenting stress

The Dyadic Parent-Child Interaction Coding System

Time Frame: 16 weeks after start of intervention

Change in positive and negative parenting skills observed during 5 minute child led play session

Eyberg Child Behavior Inventory (ECBI)

Time Frame: 16 weeks after start of intervention

Change in overall externalizing behavior problems

Child and Adolescent Trauma Screener (CATS)

Time Frame: 16 weeks after start of intervention

Change in overall PTSD symptom severity

Secondary Outcomes

  • Treatment Attendance(16 weeks after start of intervention)
  • Therapy Attitude Inventory(16 weeks after start of intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Paulo A. Graziano, PhD

Associate Professor

Florida International University

Study Sites (1)

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