Back to resultsEarly Intervention For Families Experiencing Homelessness: A Randomized Trial Comparing Two Parenting Programs
Primary Purpose
Behavior Problem, Parenting
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent Child Interaction Therapy
Child Parent Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Behavior Problem focused on measuring early intervention, parenting, homelessness, parent child interaction therapy, child parent psychotherapy, behavior problems, trauma symptoms
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.
Sites / Locations
- Lotus House
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Parent Child Interaction Therapy
Child Parent Psychotherapy
Arm Description
Parents and children will receive 12 weekly sessions of PCIT.
Parents and children will receive 12 weekly sessions of CPP
Outcomes
Primary Outcome Measures
Eyberg Child Behavior Inventory (ECBI)
Change in overall externalizing behavior problems
Child and Adolescent Trauma Screener (CATS)
Change in overall PTSD symptom severity
Parenting Stress Index Short Form 4th edition (PSI-SF)
Change in overall level of parenting stress
The Dyadic Parent-Child Interaction Coding System
Change in positive and negative parenting skills observed during 5 minute child led play session
Secondary Outcome Measures
Therapy Attitude Inventory
Mothers' satisfaction with treatment
Treatment Attendance
Percentage of families who completed the intervention
Full Information
NCT ID
NCT04459845
First Posted
June 18, 2020
Last Updated
September 30, 2021
Sponsor
Florida International University
Collaborators
Lotus House
1. Study Identification
Unique Protocol Identification Number
NCT04459845
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida International University
Collaborators
Lotus House
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Problem, Parenting
Keywords
early intervention, parenting, homelessness, parent child interaction therapy, child parent psychotherapy, behavior problems, trauma symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigator and outcomes assessor are masked to the treatment group
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parent Child Interaction Therapy
Arm Type
Active Comparator
Arm Description
Parents and children will receive 12 weekly sessions of PCIT.
Arm Title
Child Parent Psychotherapy
Arm Type
Active Comparator
Arm Description
Parents and children will receive 12 weekly sessions of CPP
Intervention Type
Behavioral
Intervention Name(s)
Parent Child Interaction Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Child Parent Psychotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eyberg Child Behavior Inventory (ECBI)
Description
Change in overall externalizing behavior problems
Time Frame
16 weeks after start of intervention
Title
Child and Adolescent Trauma Screener (CATS)
Description
Change in overall PTSD symptom severity
Time Frame
16 weeks after start of intervention
Title
Parenting Stress Index Short Form 4th edition (PSI-SF)
Description
Change in overall level of parenting stress
Time Frame
16 weeks after start of intervention
Title
The Dyadic Parent-Child Interaction Coding System
Description
Change in positive and negative parenting skills observed during 5 minute child led play session
Time Frame
16 weeks after start of intervention
Secondary Outcome Measure Information:
Title
Therapy Attitude Inventory
Description
Mothers' satisfaction with treatment
Time Frame
16 weeks after start of intervention
Title
Treatment Attendance
Description
Percentage of families who completed the intervention
Time Frame
16 weeks after start of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo Graziano, Ph.D
Organizational Affiliation
Florida International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lotus House
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Early Intervention For Families Experiencing Homelessness: A Randomized Trial Comparing Two Parenting Programs
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