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Feasibility of SUPPORT-TBI

17 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Intervención / Tratamiento

Descripción detallada

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).

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jessica Kersey, PhD, OTR/L
  • Número de teléfono: 3142737540
  • Correo electrónico: jkersey@wustl.edu

Copia de seguridad de contactos de estudio

  • Nombre: Curtis Comer, Clinical Research Coordinator I
  • Número de teléfono: 3142733288
  • Correo electrónico: curtisccomer@wustl.edu

Ubicaciones de estudio

    • Missouri
      • St Louis, Missouri, Estados Unidos, 63110
        • Reclutamiento
        • Washington University School of Medicine
        • Contacto:
          • Jessica Kersey, PhD, OTR/L
          • Número de teléfono: 3142737540
          • Correo electrónico: jkersey@wustl.edu
        • Contacto:
          • Curtis Comer, Clinical Research Coordinator I
          • Correo electrónico: jkersey@wustl.edu
        • Investigador principal:
          • Jessica Kersey

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
HEAL Treatment Expectancy Short Form
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
MOS Social Support Survey
Periodo de tiempo: 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
Periodo de tiempo: Baseline, Post-intervention (12 weeks)
Computer adaptive test examining social participation abilities; scores reported as T-scores.
Baseline, Post-intervention (12 weeks)
PROMIS-29
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Jessica Kersey, PhD, OTR/L, Washington University School of Medicine

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

17 de agosto de 2026

Finalización primaria (Estimado)

31 de diciembre de 2027

Finalización del estudio (Estimado)

31 de marzo de 2028

Fechas de registro del estudio

Enviado por primera vez

22 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de junio de 2026

Publicado por primera vez (Actual)

4 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de agosto de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 202512160
  • KL2TR002346 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Marco de tiempo para compartir 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.

Criterios de acceso compartido de 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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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