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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06246773
Other study ID # HSC-SN-23-1086
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 19, 2024
Est. completion date November 30, 2024

Study information

Verified date January 2024
Source The University of Texas Health Science Center, Houston
Contact Doncy J Eapen, PhD, MSN, APRN, FNP-BC
Phone 713-500-2302
Email Doncy.J.Eapen@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date November 30, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston Rita and Alex Hillman Foundation - Hillman Emergent Innovation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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