NCT05139251

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 inter-personal violence (IPRV) and homelessness and to promote positive parenting strategies through Play and Learning Strategies (ePALS), an evidence based intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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

November 18, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

September 7, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2023

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

10 months

First QC Date

November 18, 2021

Last Update Submit

January 30, 2024

Conditions

Keywords

Positive parentingWomen experiencing homelessnessInter-personal violence

Outcome Measures

Primary Outcomes (10)

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

    PSS is an 18-item questionnaire and the participants rate each item on a scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"), a higher score indicating more stress

    Baseline, 1 month post intervention, 3 months post 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, 1 month post intervention, 3 months post 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, 1 month post intervention, 3 months post 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, 1 month post intervention, 3 months post 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, 1 month post intervention, 3 months post 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, 1 month post intervention, 3 months post 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 (1mont-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, 1 month post intervention, 3 months post 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, 1 month post intervention, 3 months post 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, 1 month post intervention, 3 months post intervention

  • Change in perceived parent child connectedness as assessed by the Mothers Object Relational Scale- Short Form (MORS- SF) and MORS- Child scale.

    this is a 14 item scale and each item is scored from 0( never)-5(always)

    Baseline, 1 month post intervention, 3 months post intervention

Study Arms (1)

Recovering from Intimate partner violence through Strengths and Empowerment (RISE) +ePALS

EXPERIMENTAL
Other: Recovering from Intimate partner violence through Strengths and Empowerment (RISE)Other: ePALS

Interventions

RISE intervention will be implemented for a period of 4 weeks at the beginning of the program. Four components/modules of the RISE intervention which includes a) education on health effects of violence, b) improving coping and self-care, c) enhancing social support, and d) addressing sexual violence will be used. Toward the beginning of each session the participant will complete a brief survey including a 10-item general self-efficacy scale to be graphed and discussed together to provide more immediate feedback to women about their progress, and at times, inform module selection. At the conclusion of each RISE session, women are asked to set a goal related to the topic in consultation with the clinician

Recovering from Intimate partner violence through Strengths and Empowerment (RISE) +ePALS
ePALSOTHER

Participants and their children will then receive 6 weekly sessions of ePALS. The ePALS sessions include rapport building, recognizing and understanding children's signals, contingently responding to signals, labeling objects and actions, learning book reading strategies, maintaining children's focus of attention, helping children with self-regulation, and language scaffolding techniques. Each parent will have a personal parenting coach who remotely supports their progress through the program. After a parent views a PALS coaching session, they will videotape themselves trying the strategy for that week with their child. Then their coach sets up a zoom call and together they talk about the PALS strategy and view the video. The coach facilitates parental appraisal of their behavior and discuss what they thought worked with their child and what they want to do differently.

Recovering from Intimate partner violence through Strengths and Empowerment (RISE) +ePALS

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • women's report of physical, sexual or psychological abuse from a partner/ family member/ acquaintance/ stranger within the last 24 months
  • have at least one child under the age of 5 years old

You may not qualify if:

  • non-English speaking
  • physical presence of a male partner 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 Eapen, PhD, RN, FNP-BC

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 18, 2021

First Posted

December 1, 2021

Study Start

September 7, 2022

Primary Completion

June 20, 2023

Study Completion

October 19, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations