- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07625098
Feasibility of SUPPORT-TBI
17 août 2026 mis à jour par: Jessica Kersey, Washington University School of Medicine
From Isolation to Connection: A Dyadic Approach to Enhancing Health After TBI
Many people who have had a traumatic brain injury (TBI) struggle to stay connected with others.
They often lose friendships, become isolated, and have strained family relationships.
This lack of social support is linked to worse physical and mental health, lower quality of life, and even a shorter lifespan.
The investigators developed a program where a person with TBI and one close supporter work together with a therapist over 12 weekly sessions.
They learn skills in communication, setting shared goals, supporting each other emotionally, and problem-solving, with occasional guidance from a peer mentor who has been through a similar experience.
This study will determine whether the program is practical to deliver.
We are conducting a pilot study with 30 pairs of participants to test whether sessions run smoothly, whether people show up and stay engaged, and whether participants find the program worthwhile.
Based on what they learn, the investigators will refine this program before testing it on a larger scale.
If successful, this could lead to a practical, low-risk intervention that improves the lives of people with TBI and the family members and friends who support them.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
People with traumatic brain injury (TBI) experience poor long-term health and daily life participation, yet current rehabilitation approaches fail to meaningfully improve these outcomes.
Social support is closely associated with daily life participation and a range of physical and mental health outcomes.
Further, it is an important protective factor against functional decline, chronic disease, mental illness, and early mortality.
While social support is important for quality of life, few rehabilitation interventions leverage it as a mechanism for improving outcomes.
People with TBI have particularly low social support.
They experience shrinking social networks, loss of friendships, high rates of divorce, and reduced quality of family relationships.
Yet, people with TBI value strong reciprocal relationships with one or two close family members as the key component of social support.
This project will examine the feasibility of a novel dyadic intervention (SUPPORT-TBI) aimed at enhancing social support to promote greater participation and long-term health outcomes among people with TBI by improving the quality of a support relationship between the person with TBI and a close family member or friend.
The goals of this intervention are to provide the dyad with strategies to sustain an effective support relationship.
The investigators have designed SUPPORT-TBI to improve social support through five central intervention elements (1) communication strategies, (2) shared goals and activities, (3) psychosocial support, (4) peer mentorship, and (5) joint problem-solving.
This intervention was developed based on a core elements review of existing social support intervention literature in other fields and populations and was guided by input from people with brain injury, their family members, brain injury rehabilitation providers, and brain injury intervention researchers.
The investigators are currently refining it through a case series study.
Though conceptually promising, evidence-based, and rooted in stakeholder priorities, our early pilot testing of this intervention has demonstrated that the proposed 12 weekly sessions is a burdensome time commitment and is difficult to schedule when involving the person with TBI, their support person, and peer mentors.
These barriers, in addition to insurance barriers that limit coverage of outpatient and community-based rehabilitation services, suggest important implementation barriers that must be addressed as investigators refine this intervention protocol.
To address this, investigators propose to optimize the intervention using the Multiphase Optimization Strategy (MOST).
This framework will allow investigators to identify which intervention components, delivery structures, and dosages maximize efficiency without compromising intervention effects.
In the proposed study, investigators will conduct the preparation phase of the MOST framework, which involves testing the feasibility of the proposed intervention elements to inform the design of a factorial, randomized optimization trial (MOST Phase 2).
Investigators will conduct a feasibility study of the full protocol with 30 dyads, and examine participant satisfaction (HEAL Treatment Expectancy Short Form), engagement in intervention sessions(Pittsburgh Rehabilitation Participation Scale), and fidelity of delivery (study-specific fidelity checklist) of each intervention session.
Then the investigators will select the combinations of conditions to be tested in the optimization phase by refining the delivery of each intervention element for feasibility and identifying the intervention elements, dosages, and delivery models likely to contribute to intervention effects while minimizing participant burden.
This will enable the investigators to develop a thoughtful, comprehensive optimization study (MOST phase 2), and an eventual confirmation study to examine intervention effectiveness (MOST phase 3).
Type d'étude
Interventionnel
Inscription (Estimé)
60
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Jessica Kersey, PhD, OTR/L
- Numéro de téléphone: 3142737540
- E-mail: jkersey@wustl.edu
Sauvegarde des contacts de l'étude
- Nom: Curtis Comer, Clinical Research Coordinator I
- Numéro de téléphone: 3142733288
- E-mail: curtisccomer@wustl.edu
Lieux d'étude
-
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Missouri
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St Louis, Missouri, États-Unis, 63110
- Recrutement
- Washington University School of Medicine
-
Contact:
- Jessica Kersey, PhD, OTR/L
- Numéro de téléphone: 3142737540
- E-mail: jkersey@wustl.edu
-
Contact:
- Curtis Comer, Clinical Research Coordinator I
- E-mail: jkersey@wustl.edu
-
Chercheur principal:
- Jessica Kersey
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Age 18 or older
- Live in a community setting (not an institutional setting)
- Sustained a traumatic brain injury more than 6 months prior to enrollment
- Report mild-moderate TBI-related disability (score of 5 or greater) on the Glasgow Outcome Scale - Extended
- Report low social support (score of less than 50 on the MOS Social Support Survey)
Exclusion Criteria:
- Insufficient English language fluency
- Active substance use disorder (meets diagnostic criteria on the PRIME-MD MINI alcohol or non-alcoholic substances modules)
- Active, untreated psychotic disorder (meets diagnostic criteria on the PRIME-MD MINI psychotic disorders module)
- Severe memory impairment (score of less than 21 on the Montreal Cognitive Assessment)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: SUPPORT-TBI
This novel dyadic intervention incorporates essential elements of communication strategies, shared goals and activities, psychosocial support, peer mentorship, and problem-solving.
The person with TBI and a close supporter complete intervention procedures together and work to develop sustainable strategies for an effective support relationship.
The intervention is delivered in weekly 1-hour sessions for 12 consecutive weeks.
|
This novel dyadic intervention incorporates essential elements of communication strategies, shared goals and activities, psychosocial support, peer mentorship, and problem-solving.
The person with TBI and a close supporter complete intervention procedures together and work to develop sustainable strategies for an effective support relationship.
The intervention is delivered in weekly 1-hour sessions for 12 consecutive weeks.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
HEAL Treatment Expectancy Short Form
Délai: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
|
6-item measure of intervention satisfaction with a 5-point Likert scale (range 6-30).
|
Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
|
|
Pittsburgh Rehabilitation Participation Scale
Délai: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
|
Measure of engagement in intervention sessions (range 1-6); administered each session and combined into an intervention-wide engagement score.
|
Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
|
|
Study-specific fidelity checklist
Délai: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
|
Checklist measuring the percentage of adherence to the outlined intervention elements; administered each session and combined into an intervention-wide adherence rate.
|
Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
MOS Social Support Survey
Délai: Baseline, Post-intervention (12 weeks)
|
19-item questionnaire examining perceived social support on a 5-point Likert scale with transformed scores (0-100).
|
Baseline, Post-intervention (12 weeks)
|
|
PROMIS Ability to Participate in Social Roles and Activities
Délai: Baseline, Post-intervention (12 weeks)
|
Computer adaptive test examining social participation abilities; scores reported as T-scores.
|
Baseline, Post-intervention (12 weeks)
|
|
PROMIS-29
Délai: Baseline, Post-intervention (12 weeks)
|
29-item measure of multiple health domains using a 5-point Likert scale and reported as T-scores.
|
Baseline, Post-intervention (12 weeks)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jessica Kersey, PhD, OTR/L, Washington University School of Medicine
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
17 août 2026
Achèvement primaire (Estimé)
31 décembre 2027
Achèvement de l'étude (Estimé)
31 mars 2028
Dates d'inscription aux études
Première soumission
22 mai 2026
Première soumission répondant aux critères de contrôle qualité
1 juin 2026
Première publication (Réel)
4 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 août 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 202512160
- KL2TR002346 (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) ?
OUI
Description du régime IPD
This study will produce feasibility data and clinical outcome data on 30 participants with brain injury and 30 support providers, comprising 30 total dyads who complete all research procedures together.
Data collection will be performed at Washington University medical campus or community sites in and around St. Louis, MO.
Session-level outcome data will include the patient-reported HEAL Treatment Expectancy short form, the HEAL Patient-Provider Connection short form, the Pittsburgh Rehabilitation Participation Scale, and our study-specific fidelity checklist.
Intervention-level outcome data will include the Client Satisfaction Questionnaire-8, MOS Social Support Survey, PROMIS Ability to Participate in Social Roles and Activities, and PROMIS-29.
Individual level processed data will be available for sharing.
Délai de partage IPD
Data will be made available within 6 months of the end of the grant period and will remain available for a minimum of 10 years.
Critères d'accès au partage IPD
There are no anticipated factors or limitations that will affect the access, distribution, or reuse of the de-identified scientific data generated by this proposal.
Controlled access will not be used.
The data that is shared will be shared by unrestricted download.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .