Examining Effects of a Strengths-based Community-grounded Intervention for Parents and Their Young Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Parental mental health: anxiety
研究概览
简要总结
Structural inequities and historical underinvestment in marginalized communities create developmental contexts that constrain access to high-quality education, healthcare, stable housing, and other critical resources. This study evaluates effects of a strengths-based, community-led intervention on young children and their families, which aims to buffer structural inequities while recognizing families' strengths. Between ages 18-36 months, English- and Spanish-speaking families consented and were randomly assigned to the intervention group (ParentChild+) or the active control group (FamilyNutrition+). Each group received 92 contacts from a specialist matched with their demographics. For the intervention group, contact focused on supporting parents and children's early learning, and families received a book or toy each week; for the control group, contact focused on supporting child nutrition, and families received a small food voucher each week. The current study evaluates whether the intervention altered parents' mental health, children's early environments, and/or children's test performance and brain development.
详细描述
Supporting families with limited access to resources is essential for promoting children's health and well-being throughout the lifespan. Childhood socioeconomic status (SES), typically measured by parents' levels of education and income, is associated with a wide variety of childhood experiences including access to resources such as food and housing, exposure to stress, and access to educational opportunities. These experiences, in turn, pattern children's development. Here, the investigators partner with national nonprofit ParentChild+ to evaluate the effects of a strengths-based, community-led intervention on children's outcomes and parents' mental health and parenting behaviors.
The current study compares children who completed the ParentChild+ intervention between 1.5-4 years of age to a matched, active control group who received the same amount of contact and resources related to healthy food (FamilyNutrition+). Specifically, 200 families in the Philadelphia area who were predominantly living well below the poverty line were recruited by ParentChild+ staff when children were between the ages of 18 and 36 months of age. Half of families were randomly assigned to receive the organization's 92-session home visiting intervention, and the other half were assigned to a 92-contacts active control focused on healthy nutrition.
ParentChild+ Intervention.
The ParentChild+ intervention consists of two 30-minute home visits per week for 46 weeks (92 visits), in which both parent and child are present. These visits may sometimes take place remotely, if best for the family. Home visitors are a family's designated Early Learning Specialist, chosen to match the demographics of the family they are assigned to (e.g., similar racial/ethnic, cultural, and/or linguistic background, living in or from the same neighborhood, etc.). A critical component of the study's design was the intentional incorporation of feedback and input from the Early Learning Specialists (ELSs) and coordinators, all of whom were selected to reflect the cultural and linguistic backgrounds of the families they served. This cultural and linguistic matching between ELSs and families is a core tenet of the ParentChild+ model, ensuring that families are able to build trust and engage meaningfully with the program. The ELSs' lived experience within these same communities informed the approach to participant outreach, engagement, and retention, both for the intervention and the control groups. Importantly, the control group, which received nutrition-related support, was also engaged by community members with similar cultural and linguistic ties, demonstrating a consistent commitment to equity and community empowerment across the study's design. An important part of the delivery model is that families and Early Learning Specialists have shared lived experiences. The same Early Learning Specialist works with the family for the duration of the 92 visits.
The first session each week consists of the introduction of a new toy or book. These are chosen purposefully to reflect the culture, language, and community of the participants. The specific book or toy determined by the local ParentChild+; each is selected to be age-appropriate, about content that is interesting to the parent and/or child, and with the potential to introduce new vocabulary and/or opportunities for creativity and exploration, in addition to being free from stereotypes, representing people from diverse backgrounds, and including diverse authors, among other criteria. Each comes with an accompanying guide for engaging with it. The second session consists of working on techniques or strategies to use the introduced toy or book, or any combination of other materials in the home (at the parent's choosing).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Condition is masked for researchers, including those administering and evaluating outcome measures.
入排标准
- 年龄范围
- 18 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Live in Philadelphia
- •Family qualifies for free or reduced-price lunch (185% or below the federal poverty line, based on income and number of people in the household, e.g. $57,000/year for a family of 2 adults and 2 children), or is currently receiving support from other government assistance programs (e.g., the Supplemental Nutrition Assistance Program, SNAP)
- •Parents/guardians speak English or Spanish
排除标准
- •Premature birth (<34 weeks gestation)
- •Neurological or psychiatric condition
- •Hearing or vision problem
- •Language delay (if a parent reported a language problem, we followed up with additional questions; we did not exclude children under the age of 2 who were not speaking a lot, as it is more common for children to be less verbal below this age)
- •Family previously participated in ParentChild+ with an older sibling
研究组 & 干预措施
ParentChild+
The ParentChild+ intervention consists of two 30-minute home visits per week for 46 weeks (92 visits), in which both parent and child are present. These visits may sometimes take place remotely, if best for the family. Each week, the family receives a new book or toy, and tips for promoting child learning.
干预措施: ParentChild+ (Behavioral)
FamilyNutrition+
The FamilyNutrition+ active control consists of a 92-contact, 46-week program, mirroring the intervention. However, instead of meeting with an early learning specialist, families in FamilyNutrition+ receive texts, emails, and zoom calls related to healthy nutrition and recipe ideas. In addition, families receive $25/month for groceries-a similar magnitude to the cost of the books and toys they would receive in ParentChild+.
干预措施: FamilyNutrition+ (Behavioral)
结局指标
主要结局
Parental mental health: anxiety
时间窗: Collected at age 1-2 and 3-4
Parents will fill out the Generalized Anxiety Disorder 7 item scale (GAD-7), which asks seven questions about the extent to which parents have felt various symptoms of anxiety over the last two weeks (e.g., "not being able to stop or control worrying"). These are summed to create a score ranging from 0-21, with higher scores indicating more anxiety. This will be submitted to a factor analysis with the two other mental health scales to create a composite of mental health.
Parental mental health: depression
时间窗: Collected at age 1-2 and 3-4
The Patient Health Questionnaire Scale (PHQ) asks eight questions about the extent to which the parent has felt various symptoms over depression over the last two weeks (e.g., "little interest or pleasure in doing things"); responses are summed to create a score of depressive symptoms. These are summed to create a score ranging from 0-27, with higher scores indicating more depression. This will be submitted to a factor analysis with the two other mental health scales to create a composite of mental health.
Parental mental health: perceived stress
时间窗: Collected at age 1-2 and 3-4
The Perceived Stress Scale (PSS-10) asks 10 questions about stress parents experienced over the last month (e.g., "In the last month, how often have you felt that you were unable to control the important things in your life?"). Parents rate each question on a 5-point scale from "never" to "always;" responses are summed to create a score of perceived stress, ranging from 0-40, with higher scores indicating more perceived stress. This will be submitted to a factor analysis with the two other mental health scales to create a composite of mental health.
Parenting behaviors
时间窗: Collected at age 1-2 and 3-4
The multidimensional assessment of parenting scale (MAPS) asks parents to think about their parenting over the last two months and rate 34 behaviors on a 5-point scale from "never" to "always" (e.g., "I have warm and intimate times together with my child"). These are summed and averaged to produce parenting style factor scores for dimensions of hostility, physical control, lax control, positive parenting, positive reinforcement, warmth, supportiveness, broadband positive parenting, and broadband negative parenting. We will use broadband positive and negative parenting as our primary variables of interest; scores range between 1-5, with higher scores indicating more positive parenting and more negative parenting, respectively.
Parent involvement in early learning
时间窗: Collected at age 3-4
The Parent Involvement in Early Learning Scale (PIEL), was validated with a low-income sample and asks 25 questions about how frequently family members engage in various activities (e.g., "Bring the child on errands, like to the laundromat or grocery store") on a 4-point scale from "rarely" to "always." Responses are summed to scores of up to 100, to form a summary score of the family's involvement in learning activities for children, with higher scores indicating more parental involvement in early learning.
Child vocabulary
时间窗: Collected at age 1-2 and 3-4
The Macarthur Bates Communication Development Inventory (MCDI) asks about the words children says in any language, from a list of common words. Scores from all 100 words are summed to produce a score ranging from 0-100, with higher scores indicating higher vocabularies.
Child behavioral problems
时间窗: Collected at age 1-2 and 3-4
The Early Childhood Behavior Questionnaire (ECBQ) asks parents to rate how often children behaved a certain way in the last 2 weeks, on a 7-point scale from "never" to "always" (e.g., "When you were busy, how often did your child find another activity to do when asked?"). This scale produces three scores indicating attentional focusing, attentional shifting, and inhibition, ranging from 1-7, with higher scores indicating more behaviors on each trait.
Child emotional problems
时间窗: Collected at age 1-2 and 3-4
The Child Behavior Checklist (CBCL) asks parents to rate how well items describe their children now or over the last six months, on a 3-point scale from "Not true" to "Very true or often true." This produces a raw score and a t-score of children's internalizing and externalizing symptoms; t-scores typically range from 50-70, with the following clinical cut-offs: ≤ 59 indicates non-clinical symptoms, 60-64 indicates risk for problem behaviors, ≥ 65 indicates clinical symptoms.
次要结局
- Child language performance(Collected at age 4-5)
- Child reasoning performance(Collected at age 4-5)
- Child science learning performance(Collected at age 4-5)
- Child fluctuation amplitude(Collected at age 4-5)
- Child cortical thickness(Collected at age 4-5)
- Child cortical surface area(Collected at age 4-5)
- Child hippocampal volume(Collected at age 4-5)
- Child molar eruption(Collected at age 4-5)
- Child language-related brain activation(Collected at age 4-5)