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Completed

NCT Number: NCT04459845

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).

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Key information

Conditions

Behavior Problem Mental Disorders Parenting

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lotus House

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parent Child Interaction Therapy

Behavioral

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

Behavioral

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 outcomes

  1. Eyberg Child Behavior Inventory (ECBI)

    Time frame: 16 weeks after start of intervention

    Change in overall externalizing behavior problems

  2. Child and Adolescent Trauma Screener (CATS)

    Time frame: 16 weeks after start of intervention

    Change in overall PTSD symptom severity

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

    Time frame: 16 weeks after start of intervention

    Change in overall level of parenting stress

  4. 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

Secondary outcomes

  1. Therapy Attitude Inventory

    Time frame: 16 weeks after start of intervention

    Mothers' satisfaction with treatment

  2. Treatment Attendance

    Time frame: 16 weeks after start of intervention

    Percentage of families who completed the intervention

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

  • Lotus House

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2020
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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