- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02742831
A Pilot Intervention With Families of Children With Special Health Care Needs
A Theory-Based Intervention to Prevent Child Neglect in High-Risk
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This pilot randomized controlled trial will be conducted with 60 caregivers of children with special health care needs who have been reported to the child protection team at Boston Medical Center with concern for neglect that was ultimately not substantiated. Half of the subjects will be randomly assigned to receive the 6-session, one-on-one, in-person, behavioral intervention focused on problem solving, emotional regulation, and distress tolerance. The other half will be randomly assigned to the control group and will receive periodic check-ins and referrals to community resources as needed. Both groups will be followed for 12 months after randomization.
Children who have previously experienced neglect, or other forms of maltreatment, will not included in the study. Children will be defined as having special health care needs if they have a chronic physical, emotional, or behavioral condition.
With this pilot, the investigators aim to field-test study mechanics, including enrollment, randomization, and the collection of baseline and follow-up data; and obtain empiric estimates of study parameters to inform a subsequent fully-powered randomized controlled trial.
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Boston Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Primary caregiver of a child under age 7 with a special health care need, defined as a chronic physical, emotional, or behavioral health condition
- Child has been referred to the Child Protection Team for neglect that was ultimately not substantiated
- Fluent in English or Spanish
Exclusion Criteria:
- Prior history of substantiated child maltreatment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervention
The intervention group will receive a one-on-one in-person intervention of 6 sessions, each lasting approximately 60 minutes. The intervention is intended to be delivered over a period of 12 weeks, with sessions occurring every 1-2 weeks. The overview of the 6 sessions is as follows:
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The intervention group will receive a 6-session intervention. The overview of the 6 sessions is as follows:
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Comparador activo: Control
The families in the control group will be contacted by a member of the study team 6 times in 12 weeks to approximate the frequency of contact that the intervention group receives.
The study team member will check in with families on the telephone or in person and will help them connect with clinic and community resources as needed.
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The families in the control group will be contacted by a member of the study team 6 times in 12 weeks to approximate the frequency of contact that the intervention group receives.
The study team member will check in with families on the telephone or in person and will help them connect with clinic and community resources as needed.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Study Logistics - subject enrollment
Periodo de tiempo: Monthly change from baseline to 12 months post randomization
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As this is a pilot study, the primary objective is to field test study logistics, including subject enrollment.
The investigators will review monthly counts of enrolled subjects from baseline to 12 months post-randomization, and will compare the number of subjects in each study arm to target enrollment goals.
Because of emerging consensus that group-to-group comparisons in a pilot study are not only invalid but also misleading, estimating effect size is deliberately not our primary study objective.
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Monthly change from baseline to 12 months post randomization
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Study Logistics - fidelity of intervention delivery
Periodo de tiempo: 3 months post randomization
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For the intervention group, treatment fidelity will be assessed by audio taping a random 10% of sessions and scoring them with standardized instruments.
The investigators will measure the proportion of sessions delivered with fidelity.
Because of emerging consensus that group-to-group comparisons in a pilot study are not only invalid but also misleading, estimating effect size is deliberately not our primary study objective.
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3 months post randomization
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Re-referral to child protection team or social services
Periodo de tiempo: 3 months post randomization
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The investigators will obtain empirical estimates of the proportion of control group subjects to be re-referred to child protection team or social services by 3 months post randomization.
This will allow the investigators to power a later study for this dichotomous outcome.
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3 months post randomization
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Re-referral to child protection team or social services
Periodo de tiempo: 6 months post randomization
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The investigators will obtain empirical estimates of the proportion of control group subjects to be re-referred to child protection team or social services by 6 months post randomization.
This will allow the investigators to power a later study for this dichotomous outcome.
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6 months post randomization
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Re-referral to child protection team or social services
Periodo de tiempo: 12 months post randomization
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The investigators will obtain empirical estimates of the proportion of control group subjects to be re-referred to child protection team or social services by 12 months post randomization.
This will allow the investigators to power a later study for this dichotomous outcome.
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12 months post randomization
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Adherence to recommended medical care
Periodo de tiempo: 3 months post randomization
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The investigators will conduct chart review to count the number of missed medical appointments, emergency department visits, and hospitalizations in the 90 days preceding the analysis.
The investigators will specifically examine the proportion of control group subjects to experience each outcome and will use this data to power a later study.
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3 months post randomization
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Adherence to recommended medical care
Periodo de tiempo: 6 months post randomization
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The investigators will conduct chart review to count the number of missed medical appointments, emergency department visits, and hospitalizations in the 90 days preceding the analysis.
The investigators will specifically examine the proportion of control group subjects to experience each outcome and will use this data to power a later study.
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6 months post randomization
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Adherence to recommended medical care
Periodo de tiempo: 12 months post randomization
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The investigators will conduct chart review to count the number of missed medical appointments, emergency department visits, and hospitalizations in the 90 days preceding the analysis.
The investigators will specifically examine the proportion of control group subjects to experience each outcome and will use this data to power a later study.
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12 months post randomization
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Parental well-being and mental health - Quick Inventory of Depressive Symptomatology
Periodo de tiempo: Change in score from baseline to 12 months post randomization
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The investigators will use validated measures to evaluate parental well-being.
The measures include the Quick Inventory of Depressive Symptomatology.
The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (depression present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up.
This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.
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Change in score from baseline to 12 months post randomization
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Parental well-being and mental health - the Social Adjustment Scale-Short Report
Periodo de tiempo: Change in score from baseline to 12 months post randomization
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The investigators will use validated measures to evaluate parental well-being.
The measures include the Social Adjustment Scale-Short Report.
The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (social adjustment present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up.
This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.
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Change in score from baseline to 12 months post randomization
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Parental well-being and mental health - the Medical Outcomes Survey Social Support
Periodo de tiempo: Change in score from baseline to 12 months post randomization
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The investigators will use validated measures to evaluate parental well-being.
The measures include the Medical Outcomes Survey Social Support.
The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (social support present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up.
This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.
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Change in score from baseline to 12 months post randomization
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Parental well-being and mental health - the Perceived Stress Scale
Periodo de tiempo: Change in score from baseline to 12 months post randomization
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The investigators will use validated measures to evaluate parental well-being.
The measures include the Perceived Stress Scale.
The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (stress present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up.
This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.
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Change in score from baseline to 12 months post randomization
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Parental well-being and mental health - the Parenting Stress-Short Form
Periodo de tiempo: Change in score from baseline to 12 months post randomization
|
The investigators will use validated measures to evaluate parental well-being.
The measures include the Parenting Stress-Short Form.
The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (parenting stress present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up.
This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.
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Change in score from baseline to 12 months post randomization
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Parental well-being and mental health - the Parenting Scale
Periodo de tiempo: Change in score from baseline to 12 months post randomization
|
The investigators will use validated measures to evaluate parental well-being.
The measures include the Parenting Scale.
The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (parenting style present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up.
This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.
|
Change in score from baseline to 12 months post randomization
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Parental well-being and mental health - the Parent Development Interview-Revised
Periodo de tiempo: Change in score from baseline to 12 months post randomization
|
The investigators will use validated measures to evaluate parental well-being.
The measures include the Parent Development Interview-Revised.
The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (reflective functioning present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up.
This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.
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Change in score from baseline to 12 months post randomization
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Caroline J Kistin, MD, MSc, Boston University School of Medicine/Boston Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- H-35105
- 1K23HD078503-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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