- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07647900
Photography-Based Intervention for Children With Attention Deficit Hyperactivity Disorder
Photography-Based Intervention to Improve Emotion Wellbeing and Symptoms in Children With Attention Deficit Hyperactivity Disorder
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Hong Kong
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Hong Kong, Hong Kong, Hong Kong
- Ka Po Wong
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- ethnic Chinese aged between 8-12 years old
- documented diagnosis of ADHD by a psychiatrist according to the ICD-10 HKD or DSM-5 criteria
- stable on current treatment for ADHD eight weeks before baseline
- ability to read Chinese and listen to Cantonese
- able to operate a camera; 8) willingness of
- their guardians to provide informed consent
Exclusion Criteria:
- general intellectual functioning below the low-average range (estimated IQ < 80)
- unstable screened via parental declaration and medication review
- comorbid psychiatric disorder, severe physical or learning disability that prevents functional participation in photography tasks
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Photography-based intervention group
The participants in this group will have a six-weekly photography course.
Each session is about 60 minutes.
Four participants will be arranged together to conduct one session.
In each session, a photographer will teach the participants basic photography skills and give a theme for the participants to take photos which will be used for sharing in the next session.
Themes mainly are emotions and objects.
In the sharing, the photographer will ask the participants to explain the reasons why take these photos and the photographer will explain the different types of emotions to the participants based on the themes.
The participants can express their views and feelings regarding their photos.
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The programme follows a structured progression across six sessions, each building upon previous learning whilst introducing new skills and concepts. For the first session, participants build rapport and introduce photography techniques (composition, lighting) alongside emotional awareness to capture basic emotional states. For the second and third sessions, they explore personal emotions and triggers through self-portraits and visual documentation. For the fourth and fifth sessions, they focus on the ADHD journey via strength-based photo narratives and collaborative projects to enhance peer support and social learning. In the last session, they consolidated skills into personal visual toolkits for ongoing regulation, concluding with a final project presentation and maintenance planning. |
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Sin intervención: Waitlist control group
The participants maintained their Treatment-as-Usual (TAU).
Participants in the waitlist group received the identical photography-based psychoeducation program immediately after the post-intervention assessment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Emotional Awareness
Periodo de tiempo: From enrollment to the end of treatment at 8 weeks and 3-month follow-up
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Participants' emotional functioning was evaluated by a licensed clinical psychologist using an adapted version of the Emotion Awareness Questionnaire (EAQ; Rieffe et al., 2007).
To fit the clinical evaluation context and focus specifically on the core processing stages of emotion identification and expression, the questionnaire was adapted into an informant-report format consisting of two selected subscales (10 items in total): Verbal Sharing of Emotions (3 items) and Differentiating Emotions (7 items).
Items in this adapted version were rated on a 4-point Likert scale ranging from 1 (never) to 4 (always).
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From enrollment to the end of treatment at 8 weeks and 3-month follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Emotion Recognition
Periodo de tiempo: From enrollment to the end of treatment at 8 weeks and 3-month follow up
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Participants' ability to accurately identify emotional states from non-verbal cues was evaluated using a customized, 7-item Facial Emotion Recognition Task (FERT) based on the universal emotional categories established by Ekman and Friesen (1975).
Children were presented with seven distinct facial-expression stimuli, each representing a specific emotion category: happiness, surprise, anger, contempt, disgust, fear, and sadness.
The facial stimuli were presented on a computer screen by a licensed clinical psychologist.
For each item, participants were instructed to identify or label the displayed emotion.
The performance was scored based on overall accuracy (total correct answers out of 7), with higher scores indicating a better capacity for facial emotion recognition.
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From enrollment to the end of treatment at 8 weeks and 3-month follow up
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Happiness
Periodo de tiempo: From enrollment to the end of treatment at 8 weeks and 3-month follow-up
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The 4-item Subjective Happiness Scale (SHS; Lyubomirsky & Lepper, 1999) was utilized to measure subjective happiness.
Respondents rated items on a 7-point Likert scale ( 1 = strongly disagree 1=strongly disagree, 7 = strongly agree 7=strongly agree).
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From enrollment to the end of treatment at 8 weeks and 3-month follow-up
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ADHD symptoms
Periodo de tiempo: From enrollment to the end of treatment at 8 weeks and 3-month follow up
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The teacher-rated Chinese version of the Swanson, Nolan, and Pelham, Version IV (SNAP-IV-18) 18-item scale (Swanson, 1992), which assesses inattention (9 items) and hyperactivity/ impulsivity (9 items).
A 4-point Likert scale will be used, ranging from 0 (not at all) to 3 (very much).
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From enrollment to the end of treatment at 8 weeks and 3-month follow up
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HSEARS20230714001
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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