Behavior ProblemNCT04459845
Early Intervention For Families Experiencing Homelessness: A Randomized Trial Comparing Two Parenting Programs
A study testing Parent Child Interaction Therapy and Child Parent Psychotherapy in people with Behavior Problem and Parenting, run by Florida International University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior Problem, Parenting
- What is being tested?
- Parent Child Interaction Therapy and Child Parent Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any child between the ages of 2 and 5 and his/her mother who is currently homeless and living in the Lotus House shelter.
Who cannot join
- Family is already involved in a parenting program or does not speak English or Spanish.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Behavior Problem, Parenting
- Being tested
- Parent Child Interaction Therapy, Child Parent Psychotherapy
- Keywords
- early intervention, parenting, homelessness, parent child interaction therapy, child parent psychotherapy, behavior problems, trauma symptoms
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Child Interaction TherapyBehavioural
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 PsychotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Parent Child Interaction Therapy | Active comparator | Parents and children will receive 12 weekly sessions of PCIT. Receives: Behavioral: Parent Child Interaction Therapy |
| Child Parent Psychotherapy | Active comparator | Parents and children will receive 12 weekly sessions of CPP Receives: Behavioral: Child Parent Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyberg Child Behavior Inventory (ECBI)
Change in overall externalizing behavior problems
Measured: 16 weeks after start of intervention
Child and Adolescent Trauma Screener (CATS)
Change in overall PTSD symptom severity
Measured: 16 weeks after start of intervention
Parenting Stress Index Short Form 4th edition (PSI-SF)
Change in overall level of parenting stress
Measured: 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
Measured: 16 weeks after start of intervention
Secondary outcomes (2)
Therapy Attitude Inventory
Mothers' satisfaction with treatment
Measured: 16 weeks after start of intervention
Treatment Attendance
Percentage of families who completed the intervention
Measured: 16 weeks after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Aug 2017
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- Lotus House
- Responsible party
- Principal investigator, Paulo A. Graziano, PhD, Florida International University
- Investigators
- Paulo Graziano, Ph.D, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459845
- Sponsor's protocol ID
- IRB-17-0265-CR02
- Status last verified
- Sep 2021
- First submitted
- 18 Jun 2020
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified summary data from the study will be shared with other researchers upon request and after completion of study.
Publications
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.
PubMed 37166851
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention For Families Experiencing Homelessness: A Randomized Trial Comparing Two Parenting Programs
- ClinicalTrials.gov ID
- NCT04459845
- Acronym / sponsor ID
- IRB-17-0265-CR02
- Conditions
- Behavior Problem, Parenting
- Keywords
- early intervention, parenting, homelessness, parent child interaction therapy, child parent psychotherapy, behavior problems, trauma symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- Lotus House
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Child Interaction Therapy | Active comparator | Behavioral: Parent Child Interaction TherapyParents and children will receive 12 weekly sessions of PCIT. |
| Child Parent Psychotherapy | Active comparator | Behavioral: Child Parent PsychotherapyParents and children will receive 12 weekly sessions of CPP |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any child between the ages of 2 and 5 and his/her mother who is currently homeless and living in the Lotus House shelter.
Key exclusion criteria (1 listed)
- Family is already involved in a parenting program or does not speak English or Spanish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent Child Interaction TherapyParent-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. | Behavioural | Parent Child Interaction Therapy |
| Child Parent PsychotherapyChild-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. | Behavioural | Child Parent Psychotherapy |
Primary outcome
Eyberg Child Behavior Inventory (ECBI)
Time frame: 16 weeks after start of intervention
Change in overall externalizing behavior problems
Child and Adolescent Trauma Screener (CATS)
Time frame: 16 weeks after start of intervention
Change in overall PTSD symptom severity
Parenting Stress Index Short Form 4th edition (PSI-SF)
Time frame: 16 weeks after start of intervention
Change in overall level of parenting stress
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
2 secondary outcomes
Therapy Attitude Inventory
Time frame: 16 weeks after start of intervention
Treatment Attendance
Time frame: 16 weeks after start of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Derived from this study: PubMed 37166851Graziano 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.
- Individual participant dataSharing planned: Yes. De-identified summary data from the study will be shared with other researchers upon request and after completion of study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulo Graziano, Ph.D principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Child Interaction Therapy and Child Parent Psychotherapy in people with Behavior Problem and Parenting, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eyberg Child Behavior Inventory (ECBI) (time frame: 16 weeks after start of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04459845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.