NCT06246773

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 26, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

1.5 years

First QC Date

January 30, 2024

Last Update Submit

May 21, 2025

Conditions

Keywords

Women experiencing homelessness (WEH)Positive Parenting

Outcome Measures

Primary Outcomes (10)

  • Change in Women's parenting stress as assessed by the Parental Stress scale (PSS)

    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

    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

    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)

    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)

    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)

    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

    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

    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

    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.

    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

Study Arms (2)

Positive Parenting Program

EXPERIMENTAL
Behavioral: Positive Parenting Program

Usual Care

ACTIVE COMPARATOR
Behavioral: Usual Care

Interventions

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.

Positive Parenting Program
Usual CareBEHAVIORAL

Participants will receive services available to them at the shelter or housing facility

Usual Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Study Officials

  • Doncy J Eapen, PhD, MSN, APRN, FNP-BC

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

March 26, 2024

Primary Completion

September 30, 2025

Study Completion

October 30, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations