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

NCT04459845 | Completed

• 1 other identifier: IRB-17-0265-CR02
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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).

Conditions

Behavior Problem; Parenting

Keywords

early intervention; parenting; homelessness; parent child interaction therapy; child parent psychotherapy; behavior problems; trauma symptoms

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Therapy Attitude Inventory

  16 weeks after start of intervention

• Treatment Attendance

  16 weeks after start of intervention

Study Arms (2)

Parent Child Interaction Therapy

ACTIVE COMPARATOR

Parents and children will receive 12 weekly sessions of PCIT.

Behavioral: Parent Child Interaction Therapy

Child Parent Psychotherapy

ACTIVE COMPARATOR

Parents and children will receive 12 weekly sessions of CPP

Behavioral: Child Parent Psychotherapy

Interventions

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.

Parent Child Interaction Therapy

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.

Child Parent Psychotherapy

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Any child between the ages of 2 and 5 and his/her mother who is currently homeless and living in the Lotus House shelter.

You may not qualify if:

• Family is already involved in a parenting program or does not speak English or Spanish.

Sponsors & Collaborators

• Florida International University: lead
• Lotus House: collaborator

Study Sites (1)

Lotus House

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Graziano PA, Spiegel JA, Hayes T, Arcia E; Sundari Foundation. Early intervention for families experiencing homelessness: A pilot randomized trial comparing two parenting programs. J Consult Clin Psychol. 2023 Apr;91(4):192-207. doi: 10.1037/ccp0000810.

  PMID: 37166851 DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Paulo Graziano, Ph.D

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcomes assessor are masked to the treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: July 7, 2020
• Study Start: August 1, 2017
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon completion of study and for 3 years.

Locations

US (1)