Clinical trial NCT06701240: Evaluating a Strengths-based Community-grounded Intervention
Official title: Examining Effects of a Strengths-based Community-grounded Intervention for Parents and Their Young Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parenting
Child Development
Brain Development
Household and Family
Keywords: strengths-based intervention
child development
experience-dependent plasticity
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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).

The goal of the sessions is to work from the parents' strengths to build their confidence in early literacy activities, strengthen their bonds with their children, and encourage children's explorations. Referring parents to other resources is also a primary aim of the project. ParentChild+ is well-regarded by the community, as evidenced in part by the retention of parents who completed the program as later Early Learning Specialists.

FamilyNutrition+ Active Control.

The control group was designed to mirror the intervention in terms of quantity of contact and resource distribution. Like ParentChild+, it consists of a 92-contact, 46-week program. 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+. This a stringent control, as better nutrition does have the potential to nurture children's cognitive development.

Design.

Upon enrollment in the program, families are randomly assigned to a condition by ParentChild+ staff and fill out a questionnaire (T1 questionnaire). Upon completion of the program, families fill out another questionnaire (T2 questionnaire). If families dropped out during the 92-session period, they are still invited to fill out a T2 questionnaire at the time they would have completed the program. Next, when children turn 4 years old, they are invited into the lab to complete a behavioral session and a scan session.

The current study asks whether families that were assigned to the intervention, relative to the control group, have differences in parental mental health, parenting, and child outcomes.

To test the question about parental mental health, the investigators will run a linear mixed effects model that predicts the latent factor of parental mental health (from a factor analysis) from the interaction between timepoint (T1 and T2) and treatment (ParentChild+ or FamilyNutrition+), with a random intercept for participant. The investigators predict a significant interaction, such that the slope of change in parental mental health between T1 and T2 is more positive for families in the ParentChild+ condition than the FamilyNutrition+ condition. For the other questions, the investigators will repeat this analysis with measures of parenting and child outcomes in place of parental mental health.

The current study will retain as many responses as possible even when families skip questions. For the measure of parenting (MAPS, described below), analyses with T1 data show that randomly removing 50% of responses to questions on the MAPS produced scores that were highly correlated with the full score (Pearson correlation \> .9). Thus, to preserve as much data as possible, the investigators will compute average scores from all questionnaires in which families have at least 50% of questions completed.

For all analyses, the investigators will conduct the main analyses with an intent-to-treat sample: anyone randomized to the intervention or control group who was not excluded. The investigators will conduct sensitivity analyses with only those who completed at least 50% and 80% of the program, respectively, in line with ParentChild+ recommended dosage.

Measures and exclusion criteria are described in more detail in the following sections.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Parental mental health: anxiety
timeFrame: Collected at age 1-2 and 3-4
measure: Parental mental health: depression
timeFrame: Collected at age 1-2 and 3-4
measure: Parental mental health: perceived stress
timeFrame: Collected at age 1-2 and 3-4
measure: Parenting behaviors
timeFrame: Collected at age 1-2 and 3-4
measure: Parent involvement in early learning
timeFrame: Collected at age 3-4
measure: Child vocabulary
timeFrame: Collected at age 1-2 and 3-4
measure: Child behavioral problems
timeFrame: Collected at age 1-2 and 3-4
measure: Child emotional problems
timeFrame: Collected at age 1-2 and 3-4
Secondary outcomes:
measure: Child language performance
timeFrame: Collected at age 4-5
measure: Child reasoning performance
timeFrame: Collected at age 4-5
measure: Child science learning performance
timeFrame: Collected at age 4-5
measure: Child fluctuation amplitude
timeFrame: Collected at age 4-5
measure: Child cortical thickness
timeFrame: Collected at age 4-5
measure: Child cortical surface area
timeFrame: Collected at age 4-5
measure: Child hippocampal volume
timeFrame: Collected at age 4-5
measure: Child molar eruption
timeFrame: Collected at age 4-5
measure: Child language-related brain activation
timeFrame: Collected at age 4-5
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Allyson P Mackey, PhD
role: PRINCIPAL_INVESTIGATOR
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