Evaluating a Strengths-based Community-grounded Intervention

NCT06701240 | Active Not Recruiting

• 1 other identifier: 825656
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenting; Child Development; Brain Development; Household and Family

Keywords

strengths-based intervention; child development; experience-dependent plasticity

Outcome Measures

Primary Outcomes (8)

• Parental mental health: anxiety

  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.

  Collected at age 1-2 and 3-4

• Parental mental health: depression

  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.

  Collected at age 1-2 and 3-4

• Parental mental health: perceived stress

  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.

  Collected at age 1-2 and 3-4

• Parenting behaviors

  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.

  Collected at age 1-2 and 3-4

• Parent involvement in early learning

  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.

  Collected at age 3-4

• Child vocabulary

  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.

  Collected at age 1-2 and 3-4

• Child behavioral problems

  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.

  Collected at age 1-2 and 3-4

• Child emotional problems

  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.

  Collected at age 1-2 and 3-4

Secondary Outcomes (9)

• 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

Study Arms (2)

ParentChild+

EXPERIMENTAL

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.

Behavioral: ParentChild+

FamilyNutrition+

ACTIVE COMPARATOR

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+.

Behavioral: FamilyNutrition+

Interventions

ParentChild+ BEHAVIORAL

92-session early literacy focused intervention

ParentChild+

FamilyNutrition+ BEHAVIORAL

92-session active control focused on child nutrition

FamilyNutrition+

Eligibility Criteria

• Age: 18 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (17)

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  PMID: 16717171 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.

  PMID: 18752852 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.

  PMID: 6668417 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.

  PMID: 29056840 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.

  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.

  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.

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• 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.

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• 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.

  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 foniatría y Audiol. 2021;41(4):183-196.

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• Wechsler D. Wechsler intelligence scale for children, 5th edition. Published online 2014.

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• Schrank, F. A., & Wendling, B. J. (2018). The Woodcock--Johnson IV. Contemporary intellectual assessment: Theories, tests, and issues, 383.

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• 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.

  PMID: 36973514 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.

  PMID: 10984517 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.

  PMID: 11832223 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.

  PMID: 34103399 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.

  PMID: 38144236 BACKGROUND

Study Officials

• Allyson P Mackey, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Condition is masked for researchers, including those administering and evaluating outcome measures.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 22, 2024
• Study Start: June 8, 2022
• Primary Completion: June 1, 2025
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: When data collection is complete and data have been processed, for as long as researchers fit access criteria.
• Access Criteria: Researchers accessing the data must receive CITI training and be added to our study's IRB.

Locations

US (1)