- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03867968
Traumatic Brain Injury Positive Strategies (TIPS)
Brain Injury Support and Strategies for Families Impacted by Childhood TBI
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Due to the chronic nature of cognitive and behavioral problems related to TBI, parents and other family caregivers need information, resources, and training in evidence-based strategies to manage the varied and changing concerns following their child's injury. Recent research provides evidence that theory-driven, self-directed online parent training is effective in improving both child and parent outcomes.
The objective of this project is to produce the Traumatic Brain Injury Positive Strategies (TIPS) program, a comprehensive educational and training resource to help families improve their knowledge and skills to address cognitive, behavioral, and social challenges following pediatric TBI. The TIPS program will be grounded in the theory of planned behavior, which postulates that training in problem-solving leads to improved skills and increases in perceived behavioral control that mediate direct changes in parenting behaviors and indirect changes in child outcomes. The web-based product will include: (a) the Training Center, which will provide training in a range of evidence-based strategies within a problem-solving framework; and (b) the TBI Resource Center, an extensive library of educational materials, information, and resources about childhood TBI.
Approximately 216 family members will participate in the evaluation phase of this study. Participants will be randomly assigned to one of two conditions: (a) treatment (TIPS program ) or (b) control (brain injury website).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Oregon
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Eugene, Oregon, États-Unis, 97403
- Center on Brain Injury Research and Training / University of Oregon
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Adult 18 years old or older
- Have a child age 3-18 that was hospitalized overnight with a traumatic brain injury (TBI).
- Involved in the care and support of the child with the TBI.
- Live in the same household as child with a TBI.
- The child with the TBI is able to follow simple instructions such as "please eat your toast."
Exclusion Criteria:
- Does not speak and read English.
- Does not have high speed Internet access.
- Not US resident
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: TIPS Intervention
The Traumatic Brain Injury Positive Strategies (TIPS) program, is a comprehensive educational and training resource to help families.
The web-based product will include: (a) the Training Center, which will provide training in a range of evidence-based strategies within a problem-solving framework; and (b) the TBI Resource Center, an extensive library of educational materials, information, and resources about childhood TBI.
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Web-based training for family member.
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Comparateur actif: Control
An existing website related to traumatic brain injury.
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Traumatic Brain Injury website for family members.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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TIPS Change in Knowledge Survey
Délai: Baseline , at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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Survey to assess change in knowledge of research-based cognitive, behavioral, and social support strategies and self-efficacy about using those strategies in home and community settings.
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Baseline , at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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PedsQL Family Impact
Délai: Baseline and for a 3 month follow up after completed intervention.
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Administered to measure change in impact of pediatric acute and chronic health conditions on parents and the family.
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Baseline and for a 3 month follow up after completed intervention.
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Caregiver Self-Efficacy Scale
Délai: Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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25-question self-report measure, administered to measure the change in how comfortable caregivers feel about selected aspects of their parenting skills such as managing their child's behavior, being an advocate for their child, and dealing with school-related issues.
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Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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The Pediatric Quality of Life Inventory (PedsQL)
Délai: Baseline
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23 items measuring physical, emotional, social, and school function.
Caregiver report forms have been developed for children 2-18 years.
The PedsQL has been used in pediatric TBI as a quality of life outcome.
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Baseline
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PedsQL Cognitive Function
Délai: Baseline
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Measures cognitive functioning in patients with acute and chronic health conditions as well as healthy school and community populations.
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Baseline
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Health Behavior Inventory (HBI)
Délai: Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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20 items measuring the change in frequency of common brain injury symptoms (somatic, cognitive, and emotional).
It will also be used to examine the effectiveness of the interventions in promoting symptom reduction.
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Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Ann Glang, PhD, University of Oregon
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R44HD059255 (Subvention/contrat des NIH des États-Unis)
- 5R44HD059255-04 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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Essais cliniques sur Lésions cérébrales, traumatiques
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Kessler FoundationInstituto Vocacional Enrique Díaz de León A.C., Guadalajara, MexicoRecrutementTBI (Traumatic Brain Injury) ou MS (Sclérose en Plaques)États-Unis, Espagne
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