Gaining Real-Life Skills Over the Web (GROW)
7 marzo 2022 aggiornato da: Children's Hospital Medical Center, Cincinnati
Gaining Real-Life Skills Over the Web (GROW)
Gaining Real-life Skills Over the Web (GROW) is an online parenting-skills intervention for caregivers of children aged 0-4 who sustained traumatic brain injuries.
GROW is designed to promote family and child coping and adjustment for caregivers.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This project develops and evaluates an online learning environment of web-based intervention modules designed to promote family and child coping and adjustment (GROW: Gaining Real-life Skills Over the Web) based on a comprehensive needs assessment of children aged 0 to 14 years old, who experienced a traumatic brain injury (TBI) between the ages of 0 to 4 years, and their families.
The incidence of TBI peaks between the ages 0 to 4 years, yet there are no evidenced-based interventions to facilitate neurocognitive development and socio-emotional functioning of children injured during this critical development period.
To address the unmet need of caregivers of infants and toddlers with TBI, the project uses a three-phase development process to generate proof of concept and initial proof of product.
Phase 1 involves a comprehensive needs assessment that includes quantitative assessment of family and child needs, qualitative assessment through focus groups and interviews of families, feedback from family and professional advisory boards, and consultation with professionals implementing interventions with similar populations (e.g., families of children with very low birth weight).
During Phase 2, the project develops the content and manual for the intervention modules, designs the online learning environment, and conducts intensive, iterative usability testing.
Phase 3 involves a pilot of the GROW program with 20 families to evaluate its usability, acceptability, and qualitative and quantitative impact on stakeholder identified outcomes.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
18
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Ohio
-
Cincinnati, Ohio, Stati Uniti, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 1 secondo a 4 anni (Bambino)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Age at injury and enrollment: ages 0-4, inclusive
- Overnight hospitalization for traumatic brain injury
- Mechanism of injury: Non-penetrating traumatic brain injury; abusive head trauma (AHT) will be included
- Language: English must be the primary spoken language in the home
Exclusion Criteria:
- Does not reside with the caregiver at least half-time
- The caregiving situation is not stable (i.e., there must be no scheduled custody hearings)
- English is not the primary language spoken in the home
- Families of children who are non-responsive or in a persistent vegetative state will also be excluded
- Caregivers with a psychiatric hospitalization in the past year will be ineligible to participate
- If AHT is the suspected injury mechanism, the child must not reside with the suspected abuser, must have been in the current living situation for at least 6 months, and must be anticipated to remain in this living situation for the next 6 months. The study team will only recruit non-abusing caregivers (including foster parents) to participate.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: GROW Intervention
Every participant received the GROW Intervention, chose not to participate in the GROW intervention, or dropped out before completing the GROW Intervention.
|
The highly interactive GROW Program consists of 5 core modules and 1 optional, supplemental session.
Each session is expected to take 15-20 minutes to complete, and at the end of each module, parents record a 5 minute "special play time" video interacting with their child to demonstrate the skills they learned in the session.
Each online module is followed by a meeting with a trained therapist who will discuss their "special play time" video and the skills they are learning.
Parents make their way through the 5 core modules sequentially before accessing the supplemental session that may be relevant to them.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Center for Epidemiologic Studies Depression(CES-D) Scale Change
Lasso di tempo: Pre-Intervention and Immediately Post-Intervention
|
Measuring caregiver psychological distress, the CES-D consists of 20 items that are rated on a 4-point likert scale (from 1: rarely or none of the time to 4: most or all of the time).
Scores range from zero to sixty.
Higher scores indicated a higher frequency of depressive symptoms during the last week.
|
Pre-Intervention and Immediately Post-Intervention
|
|
Parenting Stress Index (PSI) Change
Lasso di tempo: Pre-Intervention and Immediately Post-Intervention
|
The study team used the 36 item short form PSI to measure caregiver stress.
Using a 4-point likert scale, the stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress.
|
Pre-Intervention and Immediately Post-Intervention
|
|
Patient-Reported Outcomes Measurement Information System Change
Lasso di tempo: Pre-Intervention and Immediately Post-Intervention
|
The study team used only the Sleep, Stress, and Anxiety Measures which are rated on a 5-point likert scale.
Each measure has a range in score from 7 to 35 with higher scores indicating greater severity.
|
Pre-Intervention and Immediately Post-Intervention
|
|
Family Burden of Injury Interview (FBII) Change
Lasso di tempo: Pre-Intervention and Immediately Post-Intervention
|
The FBII measures family burden.
Open-ended answers are coded Yes/No and are given a stress rating of 0 (not at all)-5(extremely stressful).
Caregiver responses are averaged to provide an index of injury-related family burden.
|
Pre-Intervention and Immediately Post-Intervention
|
|
MacArthur-Bates Communicative Development Inventories (MB-CDI) Change
Lasso di tempo: Pre-Intervention and Immediately Post-Intervention
|
Using the short form MB-CDIs to measure child language abilities, the scoring scale is a minimum of 0- maximum of 310 with greater scores showing better language abilities.
|
Pre-Intervention and Immediately Post-Intervention
|
|
Caregiver-Child Observation Change
Lasso di tempo: Pre-Intervention and Immediately Post-Intervention
|
Using the Parent/Child Toy Play Ratings in the Play and Learning Strategies (PALS) manual, 6 domains (warmth, contingent responsiveness, demonstration/physical teaching, verbal stimulation/scaffolds, restrictions, and negativity/intrusiveness) are rated on scales of 1 to 5 with 1 being the worst rating and 5 being the best.
|
Pre-Intervention and Immediately Post-Intervention
|
|
GROW Satisfaction Survey
Lasso di tempo: Immediately Post-Intervention
|
Satisfaction with intervention measured in both 5-point likert scale ratings (with higher values showing greater satisfaction) and open-ended feedback about participant experience in the program.
|
Immediately Post-Intervention
|
|
Background & Family Information Form
Lasso di tempo: Pre-Intervention
|
Demographics rehabilitation services
|
Pre-Intervention
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
30 settembre 2017
Completamento primario (Effettivo)
30 settembre 2021
Completamento dello studio (Effettivo)
30 settembre 2021
Date di iscrizione allo studio
Primo inviato
30 agosto 2021
Primo inviato che soddisfa i criteri di controllo qualità
3 dicembre 2021
Primo Inserito (Effettivo)
16 dicembre 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 marzo 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 marzo 2022
Ultimo verificato
1 settembre 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 90IFDV0003
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .