Evaluating a Strengths-based Community-grounded Intervention
NCT ID: NCT06701240
Last Updated: 2025-07-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
199 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-06-08
Study Completion Date
2027-08-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Parenting
Child Development
Brain Development
Household and Family
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
DOUBLE
Investigators
Outcome Assessors
Condition is masked for researchers, including those administering and evaluating outcome measures.
Study Groups
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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.
Group Type
EXPERIMENTAL
ParentChild+
Intervention Type
BEHAVIORAL
92-session early literacy focused intervention
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+.
Group Type
ACTIVE_COMPARATOR
FamilyNutrition+
Intervention Type
BEHAVIORAL
92-session active control focused on child nutrition
Interventions
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ParentChild+
92-session early literacy focused intervention
Intervention Type
BEHAVIORAL
FamilyNutrition+
92-session active control focused on child nutrition
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Months
Maximum Eligible Age
36 Months
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Pennsylvania
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Allyson P Mackey, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Site Status
Countries
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United States
References
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Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Reference Type
BACKGROUND
Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
Reference Type
BACKGROUND
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Reference Type
BACKGROUND
Parent J, Forehand R. The Multidimensional Assessment of Parenting Scale (MAPS): Development and Psychometric Properties. J Child Fam Stud. 2017 Aug;26(8):2136-2151. doi: 10.1007/s10826-017-0741-5. Epub 2017 May 9.
Reference Type
BACKGROUND
Manz, P. H., Gernhart, A. L., Bracaliello, C. B., Pressimone, V. J., & Eisenberg, R. A. (2014). Preliminary Development of the Parent Involvement in Early Learning Scale for Low-Income Families Enrolled in a Child-Development-Focused Home Visiting Program. Journal of Early Intervention, 36(3), 171-191.
Reference Type
BACKGROUND
Fenson L, Marchman VA, Thal DJ, Dale PS, Reznick JS, Bates E. MacArthur-Bates Communicative Development Inventories: User's Guide and Technical Manual. 2nd Editio. Brookes Publishing Co.; 2007.
Reference Type
BACKGROUND
Putnam SP, Gartstein MA, Rothbart MK. Measurement of fine-grained aspects of toddler temperament: the early childhood behavior questionnaire. Infant Behav Dev. 2006 Jul;29(3):386-401. doi: 10.1016/j.infbeh.2006.01.004. Epub 2006 Mar 2.
Reference Type
BACKGROUND
Achenbach TM, Ruffle TM. The Child Behavior Checklist and related forms for assessing behavioral/emotional problems and competencies. Pediatr Rev. 2000 Aug;21(8):265-71. doi: 10.1542/pir.21-8-265. No abstract available.
Reference Type
BACKGROUND
Golinkoff RM, De Villiers JG, Hirsh-Pasek K, Iglesias A, Wilson MS, Morini G, Brezack N (2017). User's Manual for the Quick Interactive Language Screener (QUILS). Paul H. Brookes Publishing Company.
Reference Type
BACKGROUND
De Villiers J, Iglesias A, Golinkoff R, Hirsh-Pasek K, Wilson MS, Nandakumar R. Assessing dual language learners of Spanish and English: Development of the QUILS: ES. Rev Logop foniatrÃa y Audiol. 2021;41(4):183-196.
Reference Type
BACKGROUND
Wechsler D. Wechsler intelligence scale for children, 5th edition. Published online 2014.
Reference Type
BACKGROUND
Schrank, F. A., & Wendling, B. J. (2018). The Woodcock--Johnson IV. Contemporary intellectual assessment: Theories, tests, and issues, 383.
Reference Type
BACKGROUND
Sydnor VJ, Larsen B, Seidlitz J, Adebimpe A, Alexander-Bloch AF, Bassett DS, Bertolero MA, Cieslak M, Covitz S, Fan Y, Gur RE, Gur RC, Mackey AP, Moore TM, Roalf DR, Shinohara RT, Satterthwaite TD. Intrinsic activity development unfolds along a sensorimotor-association cortical axis in youth. Nat Neurosci. 2023 Apr;26(4):638-649. doi: 10.1038/s41593-023-01282-y. Epub 2023 Mar 27.
Reference Type
BACKGROUND
Fischl B, Dale AM. Measuring the thickness of the human cerebral cortex from magnetic resonance images. Proc Natl Acad Sci U S A. 2000 Sep 26;97(20):11050-5. doi: 10.1073/pnas.200033797.
Reference Type
BACKGROUND
Fischl B, Salat DH, Busa E, Albert M, Dieterich M, Haselgrove C, van der Kouwe A, Killiany R, Kennedy D, Klaveness S, Montillo A, Makris N, Rosen B, Dale AM. Whole brain segmentation: automated labeling of neuroanatomical structures in the human brain. Neuron. 2002 Jan 31;33(3):341-55. doi: 10.1016/s0896-6273(02)00569-x.
Reference Type
BACKGROUND
McDermott CL, Hilton K, Park AT, Tooley UA, Boroshok AL, Mupparapu M, Scott JM, Bumann EE, Mackey AP. Early life stress is associated with earlier emergence of permanent molars. Proc Natl Acad Sci U S A. 2021 Jun 15;118(24):e2105304118. doi: 10.1073/pnas.2105304118.
Reference Type
BACKGROUND
Olson HA, Chen EM, Lydic KO, Saxe RR. Left-Hemisphere Cortical Language Regions Respond Equally to Observed Dialogue and Monologue. Neurobiol Lang (Camb). 2023 Dec 14;4(4):575-610. doi: 10.1162/nol_a_00123. eCollection 2023.
Reference Type
BACKGROUND
Other Identifiers
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825656
Identifier Type: -
Identifier Source: org_study_id
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