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Clinical Trials/NCT06246773
NCT06246773
Completed
Not Applicable

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

The University of Texas Health Science Center, Houston1 site in 1 country28 target enrollmentMarch 26, 2024

Overview

Phase
Not Applicable
Intervention
Usual Care
Conditions
Interpersonal Violence
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
28
Locations
1
Primary Endpoint
Change in social support as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v 2.0 Emotional Support
Status
Completed
Last Updated
25 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 26, 2024
End Date
October 24, 2025
Last Updated
25 days ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Doncy Eapen

Assistant Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

Arms & Interventions

Usual Care

Intervention: Usual Care

Positive Parenting Program

Intervention: Positive Parenting Program

Outcomes

Primary Outcomes

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

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.

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

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

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.

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

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.

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.

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

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.

Secondary Outcomes

  • Change in usability assessed by the System Usability Scale (SUS)(Baseline, immediately after intervention(about 6 weeks after baseline), One month after end of intervention and 3 months after end of intervention intervention)

Study Sites (1)

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