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

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).

Study Overview

• Status: Completed
• Conditions: Parenting; Behavior Problem
• Intervention / Treatment: Behavioral: Parent Child Interaction Therapy; Behavioral: Child Parent Psychotherapy

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 Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Lotus House

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Parent Child Interaction Therapy; Parents and children will receive 12 weekly sessions of PCIT.	Behavioral: Parent Child Interaction Therapy; Parent-child Interaction therapy (PCIT; Eyberg and Robinson, 1982) s a manualized evidence-based behavioral parent training program that integrates social learning and attachment theories. Parents proceed through two distinct phases: Child-Directed Interaction (CDI) resembles traditional play therapy, and Parent-Directed Interaction (PDI) resembles clinical behavior therapy. During all sessions, the therapist coaches each parent in vivo in their use of the CDI and PDI skills with their child.
ACTIVE_COMPARATOR: Child Parent Psychotherapy; Parents and children will receive 12 weekly sessions of CPP	Behavioral: Child Parent Psychotherapy; Child-parent psychotherapy (CPP; Lieberman et al., 2005) is a relationship-based treatment that integrates attachment, cognitive-behavioral, social-learning, and psychodynamic theories. CPP focuses on the child-parent relationship as a way to improve the child's adaptive functioning. Various treatment strategies are employed including a focus on safety, affect regulation, the joint construction of a trauma narrative, and engagement in developmentally appropriate activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eyberg Child Behavior Inventory (ECBI)	Change in overall externalizing behavior problems	16 weeks after start of intervention
Child and Adolescent Trauma Screener (CATS)	Change in overall PTSD symptom severity	16 weeks after start of intervention
Parenting Stress Index Short Form 4th edition (PSI-SF)	Change in overall level of parenting stress	16 weeks after start of intervention
The Dyadic Parent-Child Interaction Coding System	Change in positive and negative parenting skills observed during 5 minute child led play session	16 weeks after start of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapy Attitude Inventory	Mothers' satisfaction with treatment	16 weeks after start of intervention
Treatment Attendance	Percentage of families who completed the intervention	16 weeks after start of intervention

Collaborators and Investigators

• Sponsor: Florida International University
• Collaborators: Lotus House
• Investigators: Principal Investigator: Paulo Graziano, Ph.D, Florida International University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ACTUAL): August 1, 2021
• Study Completion (ACTUAL): August 1, 2021

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (ACTUAL): July 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: homelessness; early intervention; parenting; behavior problems; parent child interaction therapy; child parent psychotherapy; trauma symptoms
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior
• Other Study ID Numbers: IRB-17-0265-CR02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified summary data from the study will be shared with other researchers upon request and after completion of study.
• IPD Sharing Time Frame: Upon completion of study and for 3 years.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No