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

Parenting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04459845
• Other study ID #: IRB-17-0265-CR02
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: August 1, 2021

Study information

• Verified date: September 2021
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavior Problem
• Parenting
• Problem Behavior

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Lotus House	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida International University	Lotus House

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eyberg Child Behavior Inventory (ECBI)	Change in overall externalizing behavior problems	16 weeks after start of intervention
Primary	Child and Adolescent Trauma Screener (CATS)	Change in overall PTSD symptom severity	16 weeks after start of intervention
Primary	Parenting Stress Index Short Form 4th edition (PSI-SF)	Change in overall level of parenting stress	16 weeks after start of intervention
Primary	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	Therapy Attitude Inventory	Mothers' satisfaction with treatment	16 weeks after start of intervention
Secondary	Treatment Attendance	Percentage of families who completed the intervention	16 weeks after start of intervention