Ensayo de optimización factorial para probar los efectos de los componentes de intervención de afrontamiento
Promoción de un afrontamiento efectivo por parte de los niños expuestos al conflicto interparental posterior al divorcio para reducir el riesgo de problemas de salud mental
This study will identify components for inclusion in a coping intervention package to reduce mental health problems among children exposed to high interparental conflict after parental separation/divorce. Reappraisal, distraction, and relaxation coping strategies are related to fewer mental health problems among children, making intervention components based on these strategies key candidates for inclusion in an optimized coping intervention. The primary aim is to experimentally assess the main and interactive effects of three digital intervention coping components (reappraisal, distraction, relaxation) on children's coping efficacy, emotional security, and internalizing and externalizing problems. Secondary aims are to assess indirect effects of the intervention components on children's coping efficacy, emotional security, and internalizing and externalizing problems through their cognitive, emotional, and behavioral reactions to post-separation/divorce interparental conflict events.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
A randomized and counterbalanced 2x2x2 factorial trial (N = 144 children, ages 9-12) will be conducted to assess the individual effects of the three digital coping intervention components. The three components to be tested will be: (1) Reappraisal (No vs. Yes), (2) Distraction (No vs. Yes), (3) Relaxation (No vs. Yes). Components that meet a priori thresholds for meaningful change will be combined to form an intervention package that will be evaluated in a subsequent randomized controlled trial.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Arizona
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Tempe, Arizona, Estados Unidos, 85087
- Arizona State University
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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:
- child between ages 9-12 whose parents are separated or divorced
- child and one parent are fluent in English
- a parent with sufficient contact (i.e., at least 4 overnights and/or 12 daytime visits per month) with child who is willing to complete study assessments and has legal right to give permission for the child to participate in research
- child-report of high exposure to IPC (mean Z score ≥ 40th percentile on the two child report measures of IPC; score standardization based on data from 559 youth whose parents participated in an experimental parenting program)
- elevated internalizing or externalizing problems (T score in the borderline clinical range according to either child or parent report on the BPM).
Exclusion Criteria:
- in active therapy
- score ≥ 99th percentile on either internalizing and externalizing problems subscale
- endorse suicidality (will be ineligible for the study and referred for treatment)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Education
Participants will complete an educational digital module and no skills-based digital modules. |
This is a constant component; all participants will get a psychoeducation digital module. |
|
Experimental: Education + Reappraisal
Participants will complete an educational digital module and a skills-based digital module that teaches reappraisal coping. |
This is a constant component; all participants will get a psychoeducation digital module. This digital module will teach reappraisal coping skills. |
|
Experimental: Education + Distraction
Participants will complete an educational digital module and a skills-based digital module that teaches distraction coping. |
This is a constant component; all participants will get a psychoeducation digital module. This digital module will teach distraction coping skills. |
|
Experimental: Education + Relaxation
Participants will complete an educational digital module and a skills-based digital module that teaches relaxation coping. |
This is a constant component; all participants will get a psychoeducation digital module. This digital module will teach relaxation coping skills. |
|
Experimental: Education + Reappraisal + Distraction
Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches distraction coping. |
This is a constant component; all participants will get a psychoeducation digital module. This digital module will teach reappraisal coping skills. This digital module will teach distraction coping skills. |
|
Experimental: Education + Reappraisal + Relaxation
Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches relaxation coping. |
This is a constant component; all participants will get a psychoeducation digital module. This digital module will teach reappraisal coping skills. This digital module will teach relaxation coping skills. |
|
Experimental: Education + Distraction + Relaxation
Participants will complete an educational digital module and two skills-based digital modules, one that teaches distraction coping and one that teaches relaxation coping. |
This is a constant component; all participants will get a psychoeducation digital module. This digital module will teach distraction coping skills. This digital module will teach relaxation coping skills. |
|
Experimental: Education + Reappraisal + Distraction + Relaxation
Participants will complete an educational digital module and three skills-based digital modules, one that teaches reappraisal coping, one that teaches distraction coping, and one that teaches relaxation coping. |
This is a constant component; all participants will get a psychoeducation digital module. This digital module will teach reappraisal coping skills. This digital module will teach distraction coping skills. This digital module will teach relaxation coping skills. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean Child-Reported Interparental Emotional Security Score on the SIS-SF at 3-Month Follow-Up
Periodo de tiempo: approximately 3 months after posttest
|
Child-reported Security in the Interparental Subsystem Scale-Short Form (SIS-SF; Holt et al., 2020). The score is the mean of 17 items rated from 0 (not at all true) to 3 (very true for me). Higher scores indicate greater interparental emotional security (better outcome). The outcome table reports observed scores; factorial analyses adjust for baseline SIS-SF and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Child-Reported Family Emotional Security Score on the SIFS at 3-Month Follow-Up
Periodo de tiempo: approximately 3 months after posttest
|
Child-reported Security in the Family System Scale (SIFS; Forman & Davies, 2005). The score is the mean of 24 items rated from 0 (completely disagree) to 3 (completely agree). Higher scores indicate greater family emotional security (better outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline SIFS score and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Child-Reported Coping Efficacy Score on the CES at 3-Month Follow-Up
Periodo de tiempo: approximately 3 months after posttest
|
Child-reported Coping Efficacy Scale (CES; Sandler et al., 2000). The score is the mean of 7 items rated from 0 (not at all) to 3 (very). Higher scores indicate greater coping efficacy (better outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline CES score and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Child-Reported Internalizing Problems Score on the BPM at 3-Month Follow-Up
Periodo de tiempo: approximately 3 months after posttest
|
Child-reported Brief Problem Monitor (BPM) Internalizing Problems scale. The score is the mean of 6 items rated from 0 (not true) to 2 (very true). Higher scores indicate more internalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline child-reported BPM Internalizing Problems score and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Parent-Reported Internalizing Problems Score on the BPM at 3-Month Follow-Up
Periodo de tiempo: approximately 3 months after posttest
|
Parent-reported Brief Problem Monitor (BPM) Internalizing Problems scale. The score is the mean of 6 items rated from 0 (not true) to 2 (very true). Higher scores indicate more internalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline parent-reported BPM Internalizing Problems score and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Child-Reported Externalizing Problems Score on the BPM at 3-Month Follow-Up
Periodo de tiempo: approximately 3 months after posttest
|
Child-reported Brief Problem Monitor (BPM) Externalizing Problems scale. The score is the mean of 7 items rated from 0 (not true) to 2 (very true). Higher scores indicate more externalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline child-reported BPM Externalizing Problems score and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Parent-Reported Externalizing Problems Score on the BPM at 3-Month Follow-Up
Periodo de tiempo: approximately 3 months after posttest
|
Parent-reported Brief Problem Monitor (BPM) Externalizing Problems scale. The score is the mean of 7 items rated from 0 (not true) to 2 (very true). Higher scores indicate more externalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline parent-reported BPM Externalizing Problems score and prespecified covariates. |
approximately 3 months after posttest
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Karey L O'Hara, PhD, Arizona State University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00016078
- K01MH120321 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Study results will be shared through presentations at conferences and submissions in peer-reviewed journals. In addition, after taking all steps necessary to minimize possible re-identification of confidential data, I will make data, codebooks, and analysis scripts available to appropriate parties to verify findings and conclusions.
Marco de tiempo para compartir IPD
one year post data collection
Criterios de acceso compartido de IPD
qualified researchers who have gained IRB approval and pre-registered their analyses
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
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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