- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04226053
Værd at vokse Evaluering for børn (RTG)
Omfattende støtte til forældreopdragelse i den tidlige barndom og børns sundhed og udvikling
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Målet med RtG's innovative program er at hjælpe forældre med at øge sandsynligheden for, at deres børn vil gå i skole klar til at lære og fortsætte med at udnytte deres fulde potentiale inden for uddannelse, arbejde og medborgerskab. Den terapeutiske, psykodynamiske tilgang og robuste tre-årige lange forhold til familier er designet til at fungere som katalysatoren for bæredygtig, langsigtet ændring i forældreopdragelsesmetoder og familiesystemstabilitet. Kritisk og i modsætning til andre programmer, der har til formål at forbedre forældreskab og børns udvikling, mener RtG, at yde konkret materiel bistand øger effektiviteten af rådgivning og henvisninger til lavindkomstfamilier ved at reducere økonomisk stress og frigøre knappe ressourcer. Programmet bygger på årtiers forskning om vigtigheden af forældrestøtte til lavindkomstfamilier og deres børn, betydningen af konkret materiel støtte og fattigdomsbekæmpelse for at styrke børns sundhed og udvikling, og erkendelsen af, at de tidlige år er et effektivt tidspunkt til yde kritisk støtte, der påvirker langsigtede resultater. Talrige programmer, såsom hjemmebesøgsmodeller, der yder forældrestøtte til nybagte mødre med lav indkomst, har vist lovende resultater. Efter årtiers korrelationsforskning, der etablerede sammenhænge mellem indkomst, fattigdom og børns sundhed og udvikling, er der en ny litteratur, der giver overbevisende årsagsbevis for, at indkomst har betydning for børns resultater. Begge stammer af denne forskning bygger på yderligere forskning, der klart tyder på, at tidlig barndom er en nøgleperiode med sårbarhed, hvor interventioner kan gøre en varig forskel for lavindkomstbørns og deres familiers formuer. Forskningen vil bygge på denne litteratur ved at teste en intervention, der kombinerer både forældrestøtte og meningsfuld levering af materiel støtte - i det væsentlige vurderer, om en kombineret tilgang kan vise sig potentielt mere kraftfuld end summen af dens dele.
Evalueringen af RtG giver en hidtil uset mulighed for at teste den kombinerede værdi af forældreuddannelse med sociale og materielle støtte. Projektet udnytter en innovativ tilgang, der kombinerer indkomststøtte, forældreuddannelse og forbindelse til samfundstjenester for at fremme tidlig sundhed og udvikling af små børn. Både forældre- og indkomststøtteprogrammer har hver til formål at fremme lav- og moderatindkomstfamiliers positive sundhed og udvikling, men alt for ofte arbejder de isoleret, hvilket potentielt begrænser deres evne til at reducere forskelle i både forældres og børns sundhed og udvikling. RtG's innovative model giver mulighed for at teste den kombinerede effekt af disse tjenester og give værdifuld information til praktikere og politiske beslutningstagere om de synergistiske virkninger af disse programkomponenter. Den foreslåede forskning kan lette forandringer inden for den tidlige barndom ved at påvise foreløbige beviser for, at denne innovative model kan opnå påviselige effekter på nøgleproksimale resultater i løbet af det første leveår og give et første skridt mod at opbygge beviser for flerstrengede tilgange til at opfylde lavindkomstfamiliers behov. Resultaterne fra denne undersøgelse kan lede feltet mod mere integrerede tilgange, der kombinerer materiel støtte, forbindelse til ressourcer og forældrehjælp for at få reelle konsekvenser for små børns sundhed og udvikling. Room to Grow og evalueringen heraf vil give klare bidrag til udviklingen af en sundhedskultur og relevante politikker i det tidlige barndomsrum. Dette vil være den første RCT, der giver en kombination af forældre- og fællesskabsstøtte med væsentlig og bemyndigende levering af materiel støtte. Mange forældreprogrammer giver nogle udviklingsmæssigt passende bøger eller legetøj, men det er utroligt sjældent at give detail, der svarer til omkring $10.000 i støtte i løbet af de første tre leveår. Dette vil fastslå, om en model som RtG's lover at transformere forældreprogrammer i den tidlige barndom til at hjælpe med at opbygge en sundhedskultur og for at reducere sundhedsforskelle blandt børn med forskellig baggrund. Organisationen og dens ledelse ser frem til at lære af evalueringsprojektet for at forstå mere om, hvad der fungerer godt, og hvad der kunne forbedres i programleveringen og læseplanen. Teamet hos RtG har målrettet skabt en kultur, der bruger data til at informere beslutningstagning og ser frem til at forstå det fulde omfang af resultater fra RCT. RtG er i øjeblikket ved at udvikle planer for ekspansion over de næste fem år som led i en formel strategisk planlægningsproces. Organisationen håber i sidste ende at kunne betjene det dobbelte eller mere af antallet af familier i hver by, hvor den opererer, New York og Boston. De hidtidige resultater fra interne evalueringer er yderst opmuntrende. Det er forskernes håb, at andre fonde og offentlige myndigheder (eller private donorer) vil være begejstrede for at bygge videre på støtten fra Robert Wood Johnson Foundation, og at forskerne vil være i stand til at forlænge det indledende momentum, som dette projekt genererer over tid.
Projektet er designet til at undersøge proksimale resultater. På lang sigt håber forskerholdet at bygge videre på disse proksimale resultater og i sidste ende følge børn gennem skolealderen, samt i høj grad udvide antallet af børn, der er inkluderet i RCT-projektet.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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New York
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New York, New York, Forenede Stater, 10032
- Columbia University - Columbia Population Research Center (CPRC)
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Kvinde
- Skal være mindst 16 år
- I tredje trimester (uge 28-34) af graviditeten
- Mød Room to Grow-programkriterierne
- Lav indkomst
- Har brug for tjenester
Ekskluderingskriterier:
- Kan ikke læse/skrive engelsk og/eller spansk
- Han
- Sidste tredje trimester
- Allerede født
- Mellem til høj indkomst
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Intervention Group
The treatment group will consist of mothers who were randomly selected to receive Room to Grow services, which include three years of social and practical support for the mother and baby through a combination of one-on-one sessions with an expert clinical social worker in-person every three months and provision of essential baby items and equipment.
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Behandlingsgruppen vil bestå af mødre, der er tilfældigt udvalgt til at modtage Room to Grow-tjenester, som omfatter tre års social og praktisk støtte til mor og baby.
Den forskningsinformerede programmodel kombinerer skræddersyede, en-til-en sessioner med en ekspert klinisk socialarbejder personligt hver tredje måned, levering af vigtige babyartikler, herunder bøger, legetøj, tøj og udstyr (detailværdi af naturalier over tre år i gennemsnit $10.000), og forbindelser til vitale samfundsressourcer (f.eks. boliger, rettigheder, børnepasning, sociale tjenester).
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Ingen indgriben: Control Group
The control group will consist of mothers who will not receive Room to Grow services.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Mean Score of Depressive Symptoms Using the CES-D Scale
Tidsramme: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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The Center for Epidemiological Studies-Depression (CES-D), is a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The Baseline and 25-month surveys included 12 items from the scale, and the 10.5-month survey included 7 items. The subscale scores range from 0 - 21 and 0 - 36, respectively. Higher scores indicate greater depressive symptoms. |
At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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Mean Score of Perceived Stress Scale (PSS)
Tidsramme: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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The Perceived Stress Scale (PSS) is a widely used instrument for measuring the perception of general stress. This 14-item scale measures how stressful or uncontrollable participants find their lives. Respondents rate the frequency of their feelings and thoughts related to events and situations that occurred in the last month. Individual scores on the PSS can range from 0-40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. The Baseline and 10.5-month surveys included 4 items from the scale. The 25-month survey included 6 items. Scores ranged from 0 - 16 and 0 - 24, respectively. Higher scores indicate higher perceived stress levels. |
At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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Mean Score of Parental Sense of Competence Using PSOC Scale
Tidsramme: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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The Parenting Sense of Competence Scale (PSOC). The PSOC measures parental competence on two dimensions: Satisfaction and Efficacy. It is a 17-item Likert-scale questionnaire (on a 6-point scale ranging from strongly agree [1] to strongly disagree [6]), with nine questions under Satisfaction and eight under Efficacy. Satisfaction section examines the parents' anxiety, motivation and frustration, while the Efficacy section looks at the parents' competence, capability levels, and problem-solving abilities in their parental role. Scores range from 17-102. A higher score indicates a higher parenting sense of competency. The Baseline and the 10.5-month surveys included 5 items from the scale with a modified 4-point scale ranging from strongly agree [1] to strongly disagree [4]. The 25-month survey included 8 items with the modified 4-point scale. Scores ranged from 4 - 20 and 4 - 32, respectively, with higher scores indicating a higher parenting sense of competency. |
At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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Mean Score of the Confusion, Hubbub, and Order Scale (CHAOS)
Tidsramme: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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The Confusion, Hubbub, and Order Scale (CHAOS) is a questionnaire filled out by parents that is designed to assess the level of confusion and disorganization in the child's home environment. The statements are scored using a 4-point scoring system. The questionnaire consists of 15 statements, to each of which a parent or caregiver responds (1) True, or (0) False (scoring was adjusted for items that required reverse coding). Scores ranged from 0-15. The Baseline and the 10.5-month surveys included 2 items from the scale with a modified 4-point scale ranging from 0 - 3: 0 = Not at all like your own home; 1 = A little bit like your own home; 2 = Somewhat like your own home; 3 = Very much like your own home. The 25-month survey included 5 items from the scale. Item scores were averaged and ranged from 0 - 3. A higher score represents characteristics of a more chaotic, disorganized, and hurried home. |
At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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Mean Score of Cognitive Stimulation in the Home (STIMQ)
Tidsramme: 10.5 months after birth of child; 25 months after birth of child
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STIMQ is a measure of cognitive stimulation in the home consisting of 4 subscales: Availability of Learning Materials (ALM), Reading, Parental Involvement in Developmental Advance (PIDA), and Parental Verbal Responsivity (PVR). The 10-month & 25-month surveys contained 4 of the 7 items in the PVR scale to measure cognitive stimulation. Respondents reported on the frequency of verbal responsiveness during everyday routines with their child. The full PVR scale uses an 8-point response scale ranging from 0 (never) - 7 (every day) and total scores range from 0 - 49 for preschool-age children. A modified 4-point response scale ranging from 1 (not at all) - 4 (every day). The average score of the four items was used and total scores ranged from 1-4. A higher score represents more responsivity and reflects greater stimulation in the home (a more favorable outcome). |
10.5 months after birth of child; 25 months after birth of child
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Mean Score of Aggravation in Parenting Scale
Tidsramme: 10.5 months after birth of child; 25 months after birth of child
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A measurement of stress experienced by parents associated with caring for children.
It measures the amount of parenting stress brought on by changes in employment, income or other factors in the parent's life.
Research has shown that high levels of aggravation in parenting are related to mothers' employment status and to child behavior problems.
High stress and aggravation in parents are associated with poor cognitive and socioemotional development of young children.
6 of the 9 items in the scale were included in the surveys.
Response categories being (0) Strongly agree, (1) Somewhat agree, (2) Somewhat disagree, (3) Strongly disagree.
This 0-3 score is reverse coded, and items are averaged to create an overall score with higher scores indicating more stress.
Total scores ranged from 0-3.
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10.5 months after birth of child; 25 months after birth of child
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Number of Toys and Goods in the Home
Tidsramme: 10.5 months after birth of child; 25 months after birth of child
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Subjects are asked if they have certain types of developmentally appropriate toys and games in the categories of symbolic play (doll, toy pots, small car), art (crayons, Play-Doh, paint), adaptive/fine motor toys (puzzle, shape sorter, pop-up toy), language (toy letters or numbers, toys that make animal sounds) and life-size toys (toy car or animal for child to ride).
Respondents can answer yes/no for each (1=yes, 0=no).
Subjects were asked about 13 items in the 10-month survey and 16 items in the 25-month survey.
Items were replaced or supplemented for age-appropriateness at each wave.
Item responses were tallied resulting in scores ranging from 0-13 and 0-16, respectively.
A higher score or number of developmentally appropriate toys and goods in the home reflects a more favorable outcome for the child.
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10.5 months after birth of child; 25 months after birth of child
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Worry Enough Money for Baby Scale Score
Tidsramme: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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Subjects are asked to rate (on a scale of 1-10) how worried they are about having enough money to cover their baby's expenses with 1 being "Not at all worried" and 10 being "Very worried".
A lower score indicates less concern and is therefore favorable.
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At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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Mean Score of Parent Supportiveness Using the 3-bag Task
Tidsramme: At follow-up in-person meeting (42-72 months after birth of child)
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The 3-bag task utilizes a semi-structured play protocol in which the parent-child dyad is instructed to play with the toys in each of three bags in a predetermined sequence.
The semi-structured play interactions are videotaped and the parent-child behaviors scored in accordance with the 3-bag task coding scales used in the National Institute of Child Health and Human Development Study of Early Child Care.
Parent supportiveness is the average of three measures: maternal sensitivity, positive affect, and the extent to which the parent provides cognitive stimulation while interacting with their child.
Scoring for all three considers both the quantity and quality or intensity of behavioral indicators observed for each; a score of 1 represents virtually no evidence of the particular behavior and a score of 7 indicates very high levels of the behavior.
As an average of the three, parent supportiveness follows the same scoring scheme and higher scores represent a more favorable outcome.
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At follow-up in-person meeting (42-72 months after birth of child)
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Mean Score of Parent Detachment Using 3 Bag-task
Tidsramme: At follow-up in-person meeting (42-72 months after birth of child)
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The 3-bag task utilizes a semi-structured play protocol in which the parent-child dyad is instructed to play with the toys in each of three bags in a predetermined sequence.
The semi-structured play interactions are videotaped and the parent-child behaviors scored in accordance with the 3-bag task coding scales used in the NICHD Study of Early Child Care.
The parent detachment scale is based on observations of the parent's awareness of, attention to, and engagement with the child.
Behavioral indicators of detachment include being consistently inattentive, being inconsistently attentive, and/or interacting with the child in a perfunctory or indifferent manner.
Scoring considers both the quantity of behavioral indicators observed and the quality or intensity of the behaviors.
A score of 1 represents very low detachment and score of 7 indicates very high detachment.
A lower score represents a more favorable outcome.
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At follow-up in-person meeting (42-72 months after birth of child)
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Mean Proportion Correct Score on Working Memory Span Performance
Tidsramme: At follow-up in-person meeting (42- 72 months after birth of child)
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This task measures working memory.
Working memory involves holding information in short-term storage and attending to one item (i.e., a house) while overcoming interference from the other (i.e., an animal or color).
The task requires children to perform the operation of naming and holding in mind two pieces of information simultaneously and to activate one while overcoming interference occurring from the other.
The task becomes more difficult as the number of houses increases.
In the pretest phase, it is established that children can name both the colors and the animals in the task.
Children then receive three 1-house trials, three 2-house trials, and three 3-house trials.
There are 18 items.
Individually, incorrect items receive a score of 0 and correct items receive a score of 1. Item scores are averaged and the total score on this activity is a proportion correct score of all items which ranges from 0 to 1.
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At follow-up in-person meeting (42- 72 months after birth of child)
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Mean Proportion Correct Score on Inhibitory Motor Control Performance
Tidsramme: At follow-up in-person meeting (42-72 months after birth of child)
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This task measures inhibitory motor control and is a standard go no-go task.
Children are presented with a large green button on the screen that makes a "popping" sound when it is touched.
Children are instructed to touch the button every time that they see an animal (the 'go' response) except when that animal is a pig (the 'no-go' response).
No-go responses vary in difficulty depending on how many go responses preceded them.
In the pretest phase, children are asked to identify all of the animals.
During administration items, the task is presented in varying numbers of go trials prior to each no-go trial, including, in standard order, 1-go, 3-go, 3-go, 5-go, 1-go, 5-go, 7-go and 7-go.
There are 40 items.
Individually, incorrect items receive a score of 0 and correct items receive a score of 1. Item scores are averaged and the total score on this activity is a proportion correct score of all items ranging from 0 to 1.
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At follow-up in-person meeting (42-72 months after birth of child)
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Mean Proportion Correct Score on Attention Shifting Performance
Tidsramme: At follow-up in-person meeting (42-72 months after birth of child)
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This task measures attention shifting and requires children to use flexible thinking.
For the initial trials in the task, children are presented with two pictures (animals, flowers, etc.) that are similar along a single dimension of color, shape, or size.
Initially, the child is explicitly told how two of the pictures are the same in some way.
Then, the child is presented with a third picture alongside the original two and asked to state how the new picture is similar to one of the original pictures.
This task requires the child to shift his/her attention from the initial dimension of similarity to a new dimension of similarity.
In the most difficult, items all of the pictures are presented at once and children are prompted to identify both dimensions of similarity.
There are 30 items.
Incorrect items receive a score of 0 and correct items receive a score of 1. Item scores are averaged and the total score on this activity is a proportion correct score of all items ranging from 0 to 1.
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At follow-up in-person meeting (42-72 months after birth of child)
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Mean Language Total Standard Score
Tidsramme: At follow-up in-person meeting (42-72 months after birth of child)
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The Receptive One-Word Picture Vocabulary Test, Fourth Edition (ROWPVT-4) is a norm-referenced assessment that tests an individual's ability to match a spoken word with an image of an object, action, or concept.
The test targets the ability to understand the meaning of words spoken and name what is depicted on a test plate without context.
Scores range from 55 - 145.
This is a standardized language assessment based on a mean of 100 and a standard deviation of 15.
Scores of 85-115 are considered to be within the average range of functioning.
Scores above 115 are considered above average and scores below 85 are considered below average.
Scores from this measure indicate that a child's receptive vocabulary is above average, below average, or equivalent to their peers of the same age.
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At follow-up in-person meeting (42-72 months after birth of child)
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Christopher Wimer, PhD, Senior Research Scientist at CPRC, School of Social Work
Publikationer og nyttige links
Generelle publikationer
- Peacock S, Konrad S, Watson E, Nickel D, Muhajarine N. Effectiveness of home visiting programs on child outcomes: a systematic review. BMC Public Health. 2013 Jan 9;13:17. doi: 10.1186/1471-2458-13-17.
- Duncan GJ, Morris PA, Rodrigues C. Does money really matter? Estimating impacts of family income on young children's achievement with data from random-assignment experiments. Dev Psychol. 2011 Sep;47(5):1263-79. doi: 10.1037/a0023875.
- Chaudry A, Wimer C. Poverty is Not Just an Indicator: The Relationship Between Income, Poverty, and Child Well-Being. Acad Pediatr. 2016 Apr;16(3 Suppl):S23-9. doi: 10.1016/j.acap.2015.12.010.
- Duncan, G.J., Magnuson, K., Kalil, A. et al. Soc Indic Res (2012) 108: 87. https://doi.org/10.1007/s11205-011-9867-9
- Cates CB, Weisleder A, Mendelsohn AL. Mitigating the Effects of Family Poverty on Early Child Development through Parenting Interventions in Primary Care. Acad Pediatr. 2016 Apr;16(3 Suppl):S112-20. doi: 10.1016/j.acap.2015.12.015.
- Wimer C, Marti M, Brooks-Gunn J, Waldfogel J. Early Impacts of Room to Grow: A Multifaceted Intervention Supporting Parents and Children Age Zero to Three. Child Youth Serv Rev. 2021 Jul;126:106041. doi: 10.1016/j.childyouth.2021.106041. Epub 2021 Apr 30.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AAAR1340
- P2CHD058486 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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