- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04226053
Utvärdering av utrymme att växa för barn (RTG)
Omfattande föräldrastöd för tidig barndom och barns hälsa och utveckling
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Målet med RtG:s innovativa program är att hjälpa föräldrar att öka sannolikheten att deras barn kommer in i skolan redo att lära sig och fortsätta för att möta sin fulla potential inom utbildning, arbete och medborgarskap. Det terapeutiska, psykodynamiska tillvägagångssättet och robusta tre år långa relation med familjer är utformad för att fungera som katalysatorn för hållbar, långsiktig förändring av föräldraskapsmetoder och familjesystemstabilitet. Kritiskt, och i motsats till andra program som syftar till att förbättra föräldraskap och barns utveckling, anser RtG att tillhandahållande av konkret materiell hjälp förbättrar effektiviteten av rådgivning och remisser till låginkomstfamiljer genom att minska ekonomisk stress och frigöra knappa resurser. Programmet bygger på årtionden av forskning om vikten av föräldrastöd för låginkomstfamiljer och deras barn, betydelsen av konkret materiellt stöd och fattigdomsbekämpning för att förbättra barns hälsa och utveckling, och insikten om att de första åren är en effektiv tid för att ge kritiskt stöd som påverkar långsiktiga resultat. Många program, som hembesöksmodeller som ger föräldrastöd till nyblivna mammor med låg inkomst, har visat lovande resultat. Efter årtionden av korrelationsforskning som etablerar samband mellan inkomst, fattigdom och barns hälsa och utveckling, finns det en framväxande litteratur som ger övertygande orsaksbevis för att inkomst har betydelse för barns resultat. Båda stammarna av denna forskning bygger på ytterligare forskning som tydligt tyder på att tidig barndom är en nyckelperiod av sårbarhet där insatser kan göra en bestående skillnad i förmögenheterna för barn med låg inkomst och deras familjer. Forskningen kommer att bygga på denna litteratur, genom att testa en intervention som kombinerar både föräldrastöd och meningsfullt tillhandahållande av materiellt stöd - i huvudsak bedöma om ett kombinerat tillvägagångssätt kan visa sig vara potentiellt mer kraftfullt än summan av dess delar.
Utvärderingen av RtG ger en oöverträffad möjlighet att testa det kombinerade värdet av föräldrautbildning med socialt och materiellt stöd. Projektet utnyttjar ett innovativt tillvägagångssätt som kombinerar inkomststöd, föräldrautbildning och anslutning till samhällstjänster för att främja tidig hälsa och utveckling av små barn. Både föräldraskaps- och inkomststödsprogram syftar var och en till att främja låg- och medelinkomstfamiljers positiva hälsa och utveckling, men alltför ofta arbetar de isolerade, vilket potentiellt begränsar deras förmåga att minska skillnaderna i både föräldrars och barns hälsa och utveckling. RtG:s innovativa modell ger en möjlighet att testa den kombinerade effekten av dessa tjänster, och ge värdefull information till praktiker och beslutsfattare om de synergistiska effekterna av dessa programkomponenter. Den föreslagna forskningen kan underlätta förändringar inom tidig barndomsområdet genom att visa preliminära bevis för att denna innovativa modell kan uppnå påvisbara effekter på viktiga proximala resultat under det första levnadsåret och ge ett första steg mot att bygga bevis för mångsidiga metoder för att möta låginkomstfamiljers behov. Resultaten från denna studie kan leda fältet mot mer integrerade tillvägagångssätt som kombinerar materiellt stöd, anslutning till resurser och föräldrahjälp för att få verkliga effekter på hälsa och utveckling hos små barn. Room to Grow och dess utvärdering kommer att ge tydliga bidrag till utvecklingen av en hälsokultur och relevant politik i den tidiga barndomen. Detta kommer att vara den första RCT som ger en kombination av föräldraskap och gemenskapsstöd med betydande och bemyndigande tillhandahållande av materiellt stöd. Många föräldraskapsprogram tillhandahåller några utvecklingsmässigt lämpliga böcker eller leksaker, men det är otroligt sällsynt att tillhandahålla motsvarande cirka 10 000 USD i stöd under de första tre åren av livet. Detta kommer att fastställa huruvida en modell som RtGs har ett löfte om att omvandla föräldraprogram för tidig barndom för att hjälpa till att bygga en hälsokultur och för att minska hälsoskillnader bland barn med olika bakgrunder. Organisationen och dess ledning ser fram emot att lära av utvärderingsprojektet för att förstå mer om vad som fungerar bra och vad som kan förbättras i programleveransen och läroplanen. Teamet på RtG har målmedvetet skapat en kultur som använder data för att informera beslutsfattande och ser fram emot att förstå hela omfattningen av resultaten från RCT. RtG utvecklar för närvarande planer för expansion under de kommande fem åren som en del av en formell strategisk planeringsprocess. Organisationen hoppas att så småningom kunna tjäna dubbelt eller mer av antalet familjer i varje stad där den är verksam, New York och Boston. Resultaten hittills från interna utvärderingar är oerhört uppmuntrande. Det är forskarnas förhoppning att andra stiftelser och statliga myndigheter (eller privata givare) kommer att vara glada över att bygga vidare på stödet från Robert Wood Johnson Foundation och att forskarna kommer att kunna förlänga det initiala momentum som genereras av detta projekt över tiden.
Projektet är utformat för att undersöka proximala resultat. På lång sikt hoppas forskargruppen bygga vidare på dessa proximala resultat och så småningom följa barn genom skolåldern, samt avsevärt utöka antalet barn som ingår i RCT-projektet.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
New York
-
New York, New York, Förenta staterna, 10032
- Columbia University - Columbia Population Research Center (CPRC)
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Beskrivning
Inklusionskriterier:
- Kvinna
- Måste vara minst 16 år gammal
- Under tredje trimestern (vecka 28-34) av graviditeten
- Möt programkriterierna för Room to Grow
- Låg inkomst
- I behov av tjänster
Exklusions kriterier:
- Kan inte läsa/skriva engelska och/eller spanska
- Manlig
- Senaste tredje trimestern
- Redan fött
- Medel till hög inkomst
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Behandlingsgruppen kommer att bestå av mammor som slumpmässigt valts ut för att få Room to Grow-tjänster, som inkluderar tre års socialt och praktiskt stöd till mamman och barnet.
Den forskningsinformerade programmodellen kombinerar skräddarsydda, en-till-en-sessioner med en expert klinisk socialarbetare personligen var tredje månad, tillhandahållande av viktiga babyartiklar inklusive böcker, leksaker, kläder och utrustning (detaljhandelsvärde av naturaföremål över tre år i genomsnitt $10 000), och kopplingar till viktiga samhällsresurser (t.ex. bostäder, rättigheter, barnomsorg, sociala tjänster).
|
|
Inget ingripande: Control Group
The control group will consist of mothers who will not receive Room to Grow services.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean Score of Depressive Symptoms Using the CES-D Scale
Tidsram: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
|
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
|
|
Mean Score of Perceived Stress Scale (PSS)
Tidsram: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
|
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
|
|
Mean Score of Parental Sense of Competence Using PSOC Scale
Tidsram: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
|
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
|
|
Mean Score of the Confusion, Hubbub, and Order Scale (CHAOS)
Tidsram: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
|
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
|
|
Mean Score of Cognitive Stimulation in the Home (STIMQ)
Tidsram: 10.5 months after birth of child; 25 months after birth of child
|
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
|
|
Mean Score of Aggravation in Parenting Scale
Tidsram: 10.5 months after birth of child; 25 months after birth of child
|
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.
|
10.5 months after birth of child; 25 months after birth of child
|
|
Number of Toys and Goods in the Home
Tidsram: 10.5 months after birth of child; 25 months after birth of child
|
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.
|
10.5 months after birth of child; 25 months after birth of child
|
|
Worry Enough Money for Baby Scale Score
Tidsram: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
|
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.
|
At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
|
|
Mean Score of Parent Supportiveness Using the 3-bag Task
Tidsram: At follow-up in-person meeting (42-72 months after birth of child)
|
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.
|
At follow-up in-person meeting (42-72 months after birth of child)
|
|
Mean Score of Parent Detachment Using 3 Bag-task
Tidsram: At follow-up in-person meeting (42-72 months after birth of child)
|
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.
|
At follow-up in-person meeting (42-72 months after birth of child)
|
|
Mean Proportion Correct Score on Working Memory Span Performance
Tidsram: At follow-up in-person meeting (42- 72 months after birth of child)
|
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.
|
At follow-up in-person meeting (42- 72 months after birth of child)
|
|
Mean Proportion Correct Score on Inhibitory Motor Control Performance
Tidsram: At follow-up in-person meeting (42-72 months after birth of child)
|
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.
|
At follow-up in-person meeting (42-72 months after birth of child)
|
|
Mean Proportion Correct Score on Attention Shifting Performance
Tidsram: At follow-up in-person meeting (42-72 months after birth of child)
|
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.
|
At follow-up in-person meeting (42-72 months after birth of child)
|
|
Mean Language Total Standard Score
Tidsram: At follow-up in-person meeting (42-72 months after birth of child)
|
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.
|
At follow-up in-person meeting (42-72 months after birth of child)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Christopher Wimer, PhD, Senior Research Scientist at CPRC, School of Social Work
Publikationer och användbara länkar
Allmänna 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AAAR1340
- P2CHD058486 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .