- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05139251
Positive Parenting: Empowering Young Mothers Experiencing Homelessness With a History of Inter-personal Violence to Improve Parenting Strategies
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- non-English speaking
- physical presence of a male partner at the time of enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Recovering from Intimate partner violence through Strengths and Empowerment (RISE) +ePALS
|
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
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Women's parenting stress as assessed by the Parental Stress scale (PSS)
Time Frame: Baseline, 1 month post intervention, 3 months post intervention
|
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
Time Frame: Baseline, 1 month post intervention, 3 months post 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, 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
Time Frame: Baseline, 1 month post intervention, 3 months post 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, 1 month post intervention, 3 months post intervention
|
Change in women's empowerment as assessed by the Personal Progress Scale-Revised (PPS-R)
Time Frame: Baseline, 1 month post intervention, 3 months post 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, 1 month post intervention, 3 months post intervention
|
Change in self efficacy as assessed by the General Self- Efficacy Scale (GSE)
Time Frame: Baseline, 1 month post intervention, 3 months post 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, 1 month post intervention, 3 months post intervention
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Change in parent satisfaction as assessed by the Parenting Sense of Competence Scale (PSOC)
Time Frame: Baseline, 1 month post intervention, 3 months post 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, 1 month post intervention, 3 months post intervention
|
Change in children's behavior as assessed by the Devereux Early Childhood Assessments (DECA)-Infant
Time Frame: Baseline, 1 month post intervention, 3 months post intervention
|
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.
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Baseline, 1 month post intervention, 3 months post intervention
|
Change in children's behavior as assessed by the Devereux Early Childhood Assessments (DECA)-Toddler
Time Frame: Baseline, 1 month post intervention, 3 months post 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, 1 month post intervention, 3 months post intervention
|
Change in children's behavior as assessed by the Devereux Early Childhood Assessments (DECA)-Preschoolers
Time Frame: Baseline, 1 month post intervention, 3 months post 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, 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.
Time Frame: Baseline, 1 month post intervention, 3 months post intervention
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Doncy Eapen, PhD, RN, FNP-BC, The University of Texas Health Science Center, Houston
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HSC-SN-21-0869
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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