Feasibility of a Positive Parenting Program for Women Experiencing Homelessness Who Have a History of Interpersonal Violence

April 2, 2026 updated by: Doncy Eapen, The University of Texas Health Science Center, Houston

Feasibility of a Positive Parenting Program for Women Experiencing Homelessness Who Have a History of Interpersonal Violence: A Randomized Controlled Trial

The purpose of this study is to strengthen the skills and self-efficacy of women by addressing the social and emotional trauma that they have experienced from interpersonal violence (IPRV) and homelessness and to promote positive parenting strategies through Play and Learning Strategies (PALS), an evidence based intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • report of at least one physically violent act from a partner within the past 24 months
  • have at least one child 5 years or younger.

Exclusion Criteria:

  • do not speak English
  • their intimate partner is physically present at the time of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Usual Care
Behavioral: Usual Care
Participants will receive services available to them at the shelter or housing facility
Experimental: Positive Parenting Program
Behavioral: Positive Parenting Program
During the first week, women will receive one session of Recovering from Intimate partner violence through Strengths and Empowerment (RISE) and from week 2 they will receive RISE and PALS simultaneously. Participants will receive four to six components of RISE - education on health effects of violence, improving coping and self-care, enhancing social support, and addressing sexual violence, increase safety planning, and assist in making difficult decisions. During each of the PALS sessions, parents will receive instruction on four responsive parenting constructs: contingent responsiveness, warm sensitivity (responses include high levels of affection and understanding of child states), maintaining vs. redirecting attention to objects and topics of conversation, and verbal scaffolding .In addition to direct instruction, parents will video-record themselves interacting with their child and engage in self-reflection of their own parenting behavior.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Women's parenting stress as assessed by the Parental Stress scale (PSS)
Time Frame: Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
This is an 18 item questionnaire and each is scored on a 5 point scale from 1(strongly disagree) to (5strongly agree) for a score range of 18-90, higher score indicating more stress
Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
Change in social support as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v 2.0 Emotional Support
Time Frame: Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
The PROMIS emotional support tool has 16 items and the participants respond each item using a 5-point rating scale from 1(never)-5(always) a higher score indicating more emotional support
Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
Change in social support as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v 2.0 Informational Support
Time Frame: Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
The PROMIS informational support is a 10 items and participants respond each item using a 5-point rating scale (Health Measures) anchored by 1(never)-5(always) with a higher score indicating a better outcome
Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
Change in women's empowerment as assessed by the Personal Progress Scale-Revised (PPS-R)
Time Frame: Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
PPS-R is a 28-item self-report measure on which participants rate the extent to which they agreed or disagreed with each item on a 7-point scale.
Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
Change in self efficacy as assessed by the General Self- Efficacy Scale (GSE)
Time Frame: Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
GSE is a 10 item scale. Participants respond to statements such as "I can solve most problems if I invest the necessary effort" on a 4-point Likert scale anchored by 1(not at all true)-4( exactly true),the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
Change in parent satisfaction as assessed by the Parenting Sense of Competence Scale (PSOC)
Time Frame: Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
The PSOC is a 17-item scale and each item is rated on a 6-point Likert scale anchored by 1(strongly disagree to 6( strongly agree).A higher score indicates a higher parenting sense of competency
Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
Change in children's behavior as assessed by the Devereux Early Childhood Assessments (DECA)-Infant
Time Frame: Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
DECA (Infant) is a 33 item questionnaire for parents about their infants (1month-18 months) It is a 5 point behavior rating scale scored from never to very frequently which provides an assessment of within-child protective factors central to social and emotional health and resilience.
Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
Change in children's behavior as assessed by the Devereux Early Childhood Assessments (DECA)-Toddler
Time Frame: Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
DECA (Toddler) is a 36 item questionnaire. It is a 5 point behavior rating scale scored from never to very frequently which provides an assessment of within-child protective factors central to social and emotional health and resilience.
Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
Change in children's behavior as assessed by the Devereux Early Childhood Assessments (DECA)-Preschoolers
Time Frame: Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
DECA (preschoolers) is a 38 item questionnaire. It is a 5 point behavior rating scale scored from never to very frequently which provides an assessment of within-child protective factors central to social and emotional health and resilience
Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
Change in perceived parent child connectedness as assessed by the Mothers Object Relational Scale- Short Form (MORS- SF) and MORS- Child scale.
Time Frame: Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention

This measures mothers' perception on 2 scales: warmth and invasiveness. This is a 14 item scale and each item is scored from 0( never)-5(always).Warmth is scored by adding the scores from items 1,3,4,6,8,11,and 13, for an average score of 29 a higher score indicating more warmth.

Invasiveness is scored by adding the scores of items 2,5,7,9,10.12.and 14, an average score of 10 and higher score indicates worse outcome.
Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in usability assessed by the System Usability Scale (SUS)
Time Frame: Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention
This is a 10-item questionnaire and each is scored from 5 (strongly agree) to 1 (strongly disagree), maximum score range is 0-100, higher number indicating better usability.
Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rita and Alex Hillman Foundation - Hillman Emergent Innovation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Doncy J Eapen, PhD, MSN, APRN, FNP-BC, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 24, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-SN-23-1086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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