HEALTHYSTEPS + PLAYREADVIP EFFECTS ON PARENTING AND CHILD DEVELOPMENT: A RANDOMIZED IMPLEMENTATION EFFECTIVENESS TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Adult-Child Relationship Scale Score
研究概览
简要总结
This study aims to investigate the effectiveness and implementation outcomes for the integration of two evidence-based practices and interventions (EBPIs) within pediatric primary care settings: HealthySteps (HS), which provides parenting support, and PlayReadVIP, which promotes relational health through video coaching. Families will be randomized to receive either the integrated HS + PlayReadVIP model or traditional HS, and investigators will examine impacts on parenting, parent-child relationships, and child development, as well as feasibility, acceptability, and appropriateness of the integrated intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent is a biological parent or legal guardian and at least 18 years of age
- •Infants must be ≤6 months old at the time of enrollment.
- •Parents/guardians must speak either English or Spanish to ensure they can fully engage with the intervention and assessments.
- •Families must be identified as Tier 3 HealthySteps participants, indicating higher levels of need based on clinic screening for factors such as:Adverse Childhood Experiences (ACEs) and parenting challenges or vulnerabilities.
- •Parent is able to willing to provide consent for their own and their child's participation.
排除标准
- •Non-singleton child
- •Parent is unable to provide consent
- •Parent does not speak English or Spanish, as study materials (e.g., questionnaires) are available in those languages
- •Parent has a severe medical or psychiatric impairment (e.g., intellectual disability, psychosis) that would interfere with study participation
- •Parent has plans to discontinue care at NYU Langone Health - Sunset Park Family Health Centers
研究组 & 干预措施
HealthySteps + PlayReadVIP
Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, plus PlayReadVIP, which promotes relational health through video coaching.
干预措施: HealthySteps (HS) (Behavioral)
HealthySteps + PlayReadVIP
Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, plus PlayReadVIP, which promotes relational health through video coaching.
干预措施: PlayReadVIP (Behavioral)
Standard HealthySteps
Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, only.
干预措施: HealthySteps (HS) (Behavioral)
结局指标
主要结局
Adult-Child Relationship Scale Score
时间窗: Month 12
13-item assessment of parent-child relationship quality. Each item is rated on a Likert 5 scale from 1 (definitely not) to 5 (definitely). The total score is the average of item responses and ranges from 1-5; higher scores indicate a stronger and more positive relationship between the child and parent.
Stimulation Questionnaire (StimQ) Core: Reading, Teaching, Verbal Responsivity Score
时间窗: Month 12
The StimQ is a parent-report measure of the cognitive home environment, designed to assess the level of cognitive stimulation children receive at home. Items include dichotomous (yes or no) and Likert-style responses ranging from 0-4. The total score is the sum of item responses and ranges from 0 to 43; higher scores are correlated with better parental behavior.
Adult-Child Relationship Scale Score
时间窗: Month 24
13-item assessment of parent-child relationship quality. Each item is rated on a Likert 5 scale from 1 (definitely not) to 5 (definitely). The total score is the average of item responses and ranges from 1-5; higher scores indicate a stronger and more positive relationship between the child and parent.
Stimulation Questionnaire (StimQ) Core: Reading, Teaching, Verbal Responsivity Score
时间窗: Month 24
The StimQ is a parent-report measure of the cognitive home environment, designed to assess the level of cognitive stimulation children receive at home. Items include dichotomous (yes or no) and Likert-style responses ranging from 0-4. The total score is the sum of item responses and ranges from 0 to 43; higher scores are correlated with better parental behavior.
Infant Behavior Questionnaire Score
时间窗: Month 12
36-item parent-report questionnaire used to measure the temperament of an infant (3-12 months old). Each item is rated on a scale from 1 (never) to 7 (always); the total score is the average of responses and ranges from 1-7; higher scores indicating greater frequency of behaviors.
Brief Infant Toddler Social-Emotional Assessment (BITSEA) Score: Competence
时间窗: Month 12
BITSEA measures socioemotional development in toddlerhood. 11 of the items cover competence. Each item is rated on a scale from 0-2. The total BITSEA Competence Score is the sum of responses and ranges from 0-22; higher scores indicate greater functioning.
Brief Infant Toddler Social-Emotional Assessment (BITSEA) Score: Problems
时间窗: Month 12
BITSEA measures socioemotional development in toddlerhood. 31 of the items cover problems. Each item is rated on a scale from 0-2. The total BITSEA Problems Score is the sum of responses and ranges from 0-62; higher scores indicate poorer functioning.
Child Behavior Checklist Score
时间窗: Month 24
100-item questionnaire identifying problem behavior in children. Each item is rated on a scale from 0 (absent) to 2 (often occurs). The raw score is the sum of responses and is transformed into a final t-score ranging from 0-100 with a mean of 50 and standard deviation of 10. T-scores below 60 indicate non-clinical symptoms; t-scores between 60 and 64 indicate that the child is at risk for problem behaviors; and t-scores above 65 indicate clinical symptoms.
次要结局
- Edinburgh Depression Scale (EPDS) Score(Baseline)
- Edinburgh Depression Scale (EPDS) Score(Month 12)
- Perceived Stress Scale (PSS) Score(Baseline)
- Perceived Stress Scale (PSS) Score(Month 12)
- Parenting Self-Agency Measure(Baseline)
- Parenting Self-Agency Measure(Month 12)
- PROMIS: General Life Satisfaction Scale Score(Month 12)
- Dyadic Adjustment Scale Score(Baseline)
- Dyadic Adjustment Scale Score(Month 12)
- Socolar Discipline Survey Score(Month 12)
- Early Social Communication Scale (ESCS) Score(Month 12)
- MacArthur-Bates Communicative Development Inventory (CDI) Score(Month 12)
- Edinburgh Depression Scale (EPDS) Score(Month 24)
- Perceived Stress Scale (PSS) Score(Month 24)
- Parenting Self-Agency Measure(Month 24)
- Patient-Reported Outcomes Measurement Information System (PROMIS): General Life Satisfaction Scale Score(Baseline)
- PROMIS: General Life Satisfaction Scale Score(Month 24)
- Dyadic Adjustment Scale Score(Month 24)
- Socolar Discipline Survey Score(Month 24)
- Early Social Communication Scale (ESCS) Score(Month 24)
- MacArthur-Bates Communicative Development Inventory (CDI) Score(Month 24)