Un ensayo controlado aleatorio que prueba el efecto del programa Youth Mindful Awareness sobre el afecto negativo (YMAP2). (YMAP2)
Abordar el afecto negativo mediante el entrenamiento de atención plena en jóvenes en riesgo de internalizar problemas (R33)
The goal of this randomized clinical trial is to compare the effects of an online mindfulness program to an active supportive comparison condition and a no-intervention control group on reducing and preventing mood and anxiety symptoms in at-risk youth. Youth who are high on trait negative affect will be randomized to one of the three conditions. The primary outcomes of interest are reductions in momentary negative affect and internalizing problems in adolescents ages 12 to 17 years old. All participants will be evaluated prior to being randomized, after the 9-session intervention period, and at a 6-month follow-up.
The first hypothesis is that the mindfulness intervention will predict decreases in stressor-reactive momentary negative affect and internalizing symptoms. The second hypothesis is that changes in momentary negative affect will partially account for the effects of the mindfulness intervention on internalizing symptoms.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Rates of anxiety and depression in youth are substantial, causing a major unmet need for effective prevention and treatment. A salient risk factor for anxiety and depression is negative affectivity - a partially heritable propensity to experience and express more frequent, intense, and enduring aversive emotional states. Prior longitudinal studies have shown that elevated trait negative affectivity (tNA) during mid-adolescence predicted internalizing disorders later in adolescence and early adulthood, and this relation was partially mediated by changes in momentary negative affect (mNA) measured with ecological momentary assessment (EMA). The conceptual rationale for this investigation is as follows: Trait negative affectivity (tNA) is a risk factor for internalizing symptoms and disorders. tNA also predicts higher levels of momentary negative affect (mNA), measured with EMA, which in turn partially accounts for the prospective association between tNA and symptoms of anxiety and depression. Mindfulness interventions reduce both mNA and internalizing symptoms. Given these empirical relations, this study will test whether in youth with high levels of tNA, an online, coached mindfulness program reduces mNA, as measured with EMA, and whether significantly reducing mNA via a mindfulness intervention then prevents the worsening or onset of internalizing problems.
Mindfulness-based interventions have been found to reduce negative affect and internalizing symptoms in children and adolescents. This study will evaluate changes in mNA as a transdiagnostic target of mindfulness-based training in youth at high risk (i.e., high tNA) for internalizing problems, and the degree to which reductions in such mNA partially account for the effects of mindfulness training on internalizing outcomes in youth. This randomized controlled prevention trial will test the extent to which youth assigned to an online, coached mindfulness program as compared to youth in a supportive attention comparison intervention and a no-intervention control condition will show reduced mNA and its two components -- stressor-independent and stressor-reactive momentary negative affect. The mindfulness training will be implemented through mobile technology (e.g., online program). Investigating the efficacy of an online mode of delivery of mindfulness with support of a coach can advance the prevention of internalizing psychopathology in a manner that could be disseminated broadly. Such technology would improve access to care for youth who can be easily identified as being vulnerable to internalizing problems due to having high levels of tNA.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Judith A Garber, PhD
- Número de teléfono: 6153305605
- Correo electrónico: jgarber.vanderbilt@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Steven D Hollon, PhD
- Número de teléfono: 6153305604
- Correo electrónico: steven.d.hollon@vanderbilt.edu
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90095
- Reclutamiento
- University of California, Los Angeles
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Contacto:
- Michelle G Craske, PhD
- Número de teléfono: 310-825-8403
- Correo electrónico: MCraske@mednet.ucla.edu
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Contacto:
- Denise A Chavira, PhD
- Número de teléfono: 310-825-8466
- Correo electrónico: dchavira@psych.ucla.edu
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Illinois
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Evanston, Illinois, Estados Unidos, 60208
- Reclutamiento
- Northwestern University
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Contacto:
- Richard E Zinbarg, PhD
- Número de teléfono: 847-467-2290
- Correo electrónico: rzinbarg@northwestern.edu
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Contacto:
- Emma K Adam, PhD
- Número de teléfono: 847-467-2010
- Correo electrónico: ek-adam@northwestern.edu
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203-5721
- Reclutamiento
- Vanderbilt University
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Contacto:
- Judith A Garber, PhD
- Número de teléfono: 6153305605
- Correo electrónico: jgarber.vanderbilt@gmail.com
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Contacto:
- Steven D Hollon, PhD
- Número de teléfono: 6153305604
- Correo electrónico: steven.d.hollon@vanderbilt.edu
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Investigador principal:
- Judith A Garber, PhD
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Sub-Investigador:
- Steven D Hollon, PhD
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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:
- Ages 12, 13, 14, 15, 16, 17
- Parental Consent
- Participant Assent
- Live in Illinois, California, or Tennessee
Exclusion Criteria:
- current diagnosis of an anxiety or depressive disorder with significant clinical impairment
- current alcohol or substance use disorder
- current serious suicidal ideation or behavior
- lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay
- reading level below 4th grade
- not English speaking at a level that would allow them to participate in the intervention and assessments
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Mindfulness Program
The Mindfulness Program is an online, coached intervention that teaches mindfulness activities such as calm breathing, listening, acceptance, gratitude, and compassion. Participants meet with their coach weekly for nine 30-minute, weekly sessions in which they learn mindfulness skills and practice using the mindfulness exercises between sessions. Meetings are done remotely (e.g., Zoom). |
Online, coached mindfulness training program |
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Comparador activo: Supportive Active Comparison
The Supportive Active condition involves participants meeting remotely (e.g., Zoom) with a coach for nine 30-minute, weekly sessions during which teens discuss their thoughts and feelings about things going on in their life. Coaches are instructed to use active listening, open-ended questions, empathy, reflection, and unconditional positive regard. Between sessions, teens use expressive writing to describe and understand their thoughts and feelings about situations in their life. |
Remote meetings with a supportive coach
Otros nombres:
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Sin intervención: Control
This is an assessment only control condition. Participants complete all of the same measures as do youth in the other two conditions at the same time points (i.e., baseline, post-intervention (about 10 weeks after baseline) and at a six-month follow-up. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Ecological Momentary Assessment of Momentary Negative Affect and Stress
Periodo de tiempo: week 10
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EMA involves assessments four times a day for 7 days. The measures of momentray negative affect (mNA) from the EMA are Stressor-Independent (mNA-SI), Stressor-Reactive (mNA-SR), and average mNA. |
week 10
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Internalizing symptoms factor
Periodo de tiempo: week 12
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The internalizing symptoms factor is based on a principal components analyses (PCAs) of the change scores for child symptom scales including the Negative Affectivity (NA-15), the Patient Health Question 9 (PHQ9 - measure of depressive symptoms), Generalized Anxiety Disorder 7 (GAD7 - measure of symptoms of anxiety), and the Screen for Child Anxiety Related Disorders (SCARED). |
week 12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Internalizing symptoms factor
Periodo de tiempo: Six-months
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The internalizing symptoms factor is based on a principal components analyses (PCAs) of the change scores for child symptom scales including the Negative Affectivity (NA-15), the Patient Health Question 9 (PHQ9 - measure of depressive symptoms), Generalized Anxiety Disorder 7 (GAD7 - measure of symptoms of anxiety), and the Screen for Child Anxiety Related Disorders (SCARED). |
Six-months
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Diagnoses of Anxiety and Depressive Disorders
Periodo de tiempo: week 12
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The Schedule for Affective Disorders and Schizophrenia for School-Age Children - Present and Lifetime Version assesses diagnoses at and since baseline and screens for exclusion criteria at baseline (Kaufman et al., 1997). |
week 12
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Diagnoses of Anxiety and Depressive Disorders
Periodo de tiempo: Six-months
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The Schedule for Affective Disorders and Schizophrenia for School-Age Children - Present and Lifetime Version (KSADs-PL) assesses diagnoses of anxiety and depressive disorders since the post-intervention assessment. |
Six-months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Megan M Saylor, PhD, Vanderbilt University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Palabras clave
Otros números de identificación del estudio
- R33MH119270 (Subvención/contrato del NIH de EE. UU.)
- 4R33MH119270-03 (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.
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