Positive ParentingNCT05139251
Positive Parenting: Empowering Young Mothers Experiencing Homelessness With a History of Inter-personal Violence to Improve Parenting Strategies
A study testing Recovering from Intimate partner violence through Strengths and Empowerment (RISE) and ePALS in people with Positive Parenting, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 inter-personal violence (IPRV) and homelessness and to promote positive parenting strategies through Play and Learning Strategies (ePALS), an evidence based… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Positive Parenting
- What is being tested?
- Recovering from Intimate partner violence through Strengths and Empowerment (RISE) and ePALS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2022to 19 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- non-English speaking
- physical presence of a male partner at the time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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.
- Conditions
- Positive Parenting
- Being tested
- Recovering from Intimate partner violence through Strengths and Empowerment (RISE), ePALS
- Keywords
- Positive parenting, Women experiencing homelessness, Inter-personal violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovering from Intimate partner violence through Strengths and Empowerment (RISE)Other
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
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.
| Study group | Role | What they receive |
|---|---|---|
| Recovering from Intimate partner violence through Strengths and Empowerment (RISE) +ePALS | Experimental | Not described Receives: Other: Recovering from Intimate partner violence through Strengths and Empowerment (RISE); Other: ePALS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Baseline, 1 month post intervention, 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start7 Sep 2022
- Primary completion20 Jun 2023
- Study completion19 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive ParentingStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doncy Eapen, The University of Texas Health Science Center, Houston
- Investigators
- Doncy Eapen, PhD, RN, FNP-BC, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139251
- Sponsor's protocol ID
- HSC-SN-21-0869
- Status last verified
- Jan 2024
- First submitted
- 18 Nov 2021
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Parenting: Empowering Young Mothers Experiencing Homelessness With a History of Inter-personal Violence to Improve Parenting Strategies
- ClinicalTrials.gov ID
- NCT05139251
- Acronym / sponsor ID
- HSC-SN-21-0869
- Conditions
- Positive Parenting
- Keywords
- Positive parenting, Women experiencing homelessness, Inter-personal violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- non-English speaking
- physical presence of a male partner at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recovering from Intimate partner violence through Strengths and Empowerment (RISE)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 | Other | Recovering from Intimate partner violence through Strengths and Empowerment (RISE) +ePALS |
| ePALSParticipants 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. | Other | Recovering from Intimate partner violence through Strengths and Empowerment (RISE) +ePALS |
Primary outcome
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
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
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
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.
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.
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
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.
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.
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doncy Eapen, PhD, RN, FNP-BC principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovering from Intimate partner violence through Strengths and Empowerment (RISE) and ePALS in people with Positive Parenting, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.