Optimizing Treatment for Depressed Parents of Children With Emotional and Behavioural Problems (OPTED)
4 de agosto de 2026 actualizado por: Brendan Andrade, University of Toronto
Optimizing Treatment for Depressed Parents of Children With Emotional and Behavioural Problems (OPTED): A Randomized and Controlled Trial
Standard Behavioral Parent Training (BPT) is often less effective for parents experiencing depression. As such, the Addressing Depression and Positive Parenting Techniques (ADAPT) intervention is a novel BPT tailored to address the unique emotional and cognitive needs of depressed parents to improve treatment outcomes.
The objective of this study is to determine the efficacy of ADAPT in reducing child emotional and behavioral difficulties compared to the gold-standard Incredible Years Parenting Program (IYPP).
This study is a 4-year, individually-randomized group treatment (IRGT), parallel-group trial. We aim to recruit 180 caregivers and their children (aged 6-11 years) seeking treatment for their child's emotional and behavioral difficulties from multiple mental health centres across Toronto, including but not limited to the University of Toronto, Centre for Addiction and Mental Health (CAMH), and Women's College Hospital (WCH).
Participants will be asked to complete research measures:
- before randomization
- post-treatment
- 6 months after the end of treatment
Participants will be randomized to either the experimental ADAPT intervention - A 10-session virtual program (1 individual, 9 group) focused on emotion regulation, distress tolerance, and cognitive restructuring, or the control intervention: Incredible Years Parent Program (IYPP) - A 12-session gold-standard BPT delivered virtually.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
180
Fase
- No aplica
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: Brendan Andrade, PhD
- Número de teléfono: 416-946-5905
- Correo electrónico: brendan.andrade@utoronto.ca
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá
- Reclutamiento
- Ontario Institute for Studies in Education (OISE)
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Contacto:
- Madison Moloney
- Número de teléfono: 30525 416-535-8501
- Correo electrónico: madison.moloney@utoronto.ca
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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:
- 18 years of age or above
- has a child aged 6-11 years with clinically elevated emotional and behavioural disorders (Abnormal Range, 93rd percentile) on the Total Difficulties Scale of the Strength and Difficulties Questionnaire (SDQ)
- parent shows clinical elevations for mild-moderate depression on the Patient Health Questionnaire-8 (PHQ-8) (>4 and <15)
- capacity to tolerate a virtual group context assessed by clinical interview
Exclusion Criteria:
- Parent shows active suicidal ideation, substance use disorder, or psychosis
- they cannot communicate in English
- child previously diagnosed with autism or an intellectual disability
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: ADAPT Treatment
Participants in the experimental arm will receive the novel Addressing Depression and Positiving Parenting Techniques (ADAPT) treatment.
ADAPT is a targeted treatment adapted by the Co-PI based on the Parenting a Child Who Has Intense Emotions program.
The treatment has modules that help parents build emotion regulation skills, distress tolerance skills, and helpful ways of thinking about their parenting.
The program also contains components of standard behavioural parent training, including strategies to build family structure, routines, and predictable parenting responses to children's behavioral challenges.
Additionally, ADAPT includes elements of Dialectical Behaviour Therapy (DBT), an effective intervention for the treatment of adults and youth with dysregulated emotion and behavior.
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ADAPT is a 10-session virtual caregiver program (one individual engagement session and nine group sessions) that was developed with clinician and parent input.
The initial engagement session is an individual meeting between the group facilitator and parent to build rapport and learn about the parent's unique challenges and parenting needs.
Based on a motivational interviewing framework, this session is designed to gather information, discuss readiness for treatment and goals.
The questions and tools used in this session help to build a collaborative understanding of unique child and parent needs that may be addressed through ADAPT and leave the parent with the hope that ADAPT can be helpful.
The 9 virtual group treatment sessions that follow include modules to help parents understand the multiple potential contributions to their child's emotional/behavioral challenges, build their own emotion regulation skills, distress tolerance skills, and more helpful ways of thinking.
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Comparador activo: Incredible Years Parenting Program (IYPP)
Participants randomized to the control arm will receive the Incredible Years Parenting Program (IYPP).
IYPP is a best-practice and widely used treatment for parents of children with EBD.
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The 12-session manualized treatment is considered a gold-standard treatment because it has shown efficacy in large-scale randomized and controlled trials and meta-analyses.
Parents are helped to shift their children's emotional and behavioral difficulties through improved parental skills and competencies with behaviour management, and a parental problem-solving approach.
IYPP will be delivered virtually.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in child emotional and behavioral difficulties
Periodo de tiempo: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Child emotional and behavioural difficulties are assessed using the Behaviour and Feelings Survey (BFS).
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in parental depression
Periodo de tiempo: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Parental depression is assessed using the Patient Health Questionnaire (PHQ-8).
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Changes in parental quality of life
Periodo de tiempo: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Quality of life is assessed using the World Health Organization Disability Assessment 2.0 (WHODAS).
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Changes in broad parenting practices
Periodo de tiempo: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Parenting practices are assessed using the Multidimensional Assessment of Parenting (MAPS).
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Changes in parental stress
Periodo de tiempo: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Parental stress is assessed using the self-reported scores on items of the Stress subscale of the Depression, Anxiety, and Stress Scale (DASS-21).
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in parental cognition
Periodo de tiempo: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Parent cognition is assessed using the Parent Cognition Scale (PCS).
The PCS will be examined as a predictor of initial symptom severity and potential treatment mechanism.
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Changes in parent emotion regulation
Periodo de tiempo: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Parent emotion regulaiton is assessed using the Affect Regulation Checklist (ARC).
The PCS will be examined as a predictor of initial symptom severity and potential treatment mechanism.
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Changes in real-time parent-reported child emotional and behavioral difficulties
Periodo de tiempo: Baseline (pre-randomization) and post-treatment (12-weeks post-randomization)
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Real-time parent-reported child emotional and behavioral difficulties will be assessed via ecological momentary assessment (EMA) at pre- and post-treatment, capturing momentary ratings of child symptoms.
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Baseline (pre-randomization) and post-treatment (12-weeks post-randomization)
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Changes in the implementation of parenting skills
Periodo de tiempo: Baseline (pre-randomization) and post-treatment (12-weeks post-randomization).
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Implementation of parenting skills is assessed using the Parenting Skill Use Diary (PSUD).
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Baseline (pre-randomization) and post-treatment (12-weeks post-randomization).
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Changes in child depressive symptoms
Periodo de tiempo: Baseline (pre-randomization) and post-treatment (12-weeks post-randomization).
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Child depressive symptoms will be assessed using the child-reported Short Mood and Feelings Questionnaire (SMFQ).
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Baseline (pre-randomization) and post-treatment (12-weeks post-randomization).
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Changes in child irritability
Periodo de tiempo: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Child irritability will be assessed using the parent-reported Affective Reactivity Index (ARI).
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Changes in child perceptions of parenting behaviour
Periodo de tiempo: Baseline (pre-randomization) and post-treatment (12-weeks post-randomization)
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Child perceptions of parenting behaviour will be assessed using the Children's Report of Parenting Behavior Inventory (CRPBI).
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Baseline (pre-randomization) and post-treatment (12-weeks post-randomization)
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Changes in parental competence need satisfaction and frustration
Periodo de tiempo: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Parental competence need satisfaction and frustration will be assessed using the relevant subscales of the Basic Psychological Need Satisfaction and Frustration Scale (BPNSFS).
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Changes in child callous-unemotional traits
Periodo de tiempo: Baseline (pre-randomization), post-treatment (12 weeks post-randomization), and 6-month follow-up
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Child callous-unemotional traits will be assessed using the Inventory of Callous-Unemotional Traits (ICU).
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Baseline (pre-randomization), post-treatment (12 weeks post-randomization), and 6-month follow-up
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Changes in child self-reported emotion-regulation
Periodo de tiempo: Baseline (pre-randomization) and post-treatment (12 weeks post-randomization)
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Child self-reported emotion-regulation will be assessed using the Children's Emotion Management Scales (CEMS).
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Baseline (pre-randomization) and post-treatment (12 weeks post-randomization)
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Changes in parental self-efficacy
Periodo de tiempo: Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Parental self-efficacy is assessed using the Parenting Sense of Competence Scale (PSOC).
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Baseline (pre-randomization), post-treatment (12-weeks post-randomization), and 6-month follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de agosto de 2030
Finalización del estudio (Estimado)
1 de agosto de 2030
Fechas de registro del estudio
Enviado por primera vez
8 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de agosto de 2026
Publicado por primera vez (Actual)
6 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 50526 (SMART IRB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified study data may be shared with other reseachers upon request at the disrection of the PI.
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. .