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Идёт набор NCT06194994

Emotion Regulation as a Moderator of Two Different Treatments for Children With ODD

Без фазы С лечением Oppositional Defiant Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Parent Management Training, Tuning Your Temper.
Кому может быть актуально
Состояния в реестре: Oppositional Defiant Disorder. Базовые параметры: 6 лет — 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Iceland
Следующий шаг
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Официальное название

Emotion Regulation as a Moderator of Two Different Treatments for Children With Oppositional Defiant Disorder: A Randomized Clinical Trial

Обзор

The goal of this randomized controlled trial is to is to test emotion regulation as a moderator of two different treatments for children with Oppositional Defiant Disorder (ODD). The main question it aims to answer is whether treatment gains be increased when children with ODD receive a treatment congruent with their emotion regulation skill problems. Participants will be divided into two groups based on their response patterns; a high emotion dysregulation group and a low emotion dysregulation group. Within each group, children will then be randomly assigned to either a behavioral parent training intervention or a child directed treatment involving problem solving and emotion regulation skills.

Подробное описание

Emotion regulation has been implicated in the development of ODD. Two types of treatment are commonly used for children with ODD, behavioral parent training and child directed cognitive treatments. Parent training focuses on increasing compliance and reducing defiant behaviour while the child directed treatments focus on increasing the child's problem solving skills and emotion regulation. The investigators will assess emotion regulation and emotional lability in children diagnosed with ODD and divide them into two groups based on their response patterns; a high emotion dysregulation group and a low emotion dysregulation group. Within each group, children will then be randomly assigned to either a behavioral parent training intervention or a child directed treatment involving problem solving and emotion regulation skills, which makes it possible to assess the effects of the different interventions for the two distinct groups. Treatment effects will be assessed at pre- and post-treatment as well as at 6 and 18 month follow-up. Comorbid conditions will be tested as moderators.

Вмешательства

  • Поведенческое Parent Management Training
    Behavioral parent training program aimed at increasing compliance and positive behaviours while decreasing disruptive behaviours
  • Поведенческое Tuning Your Temper
    Cognitive behavioural treatment for children focusing on arousal reduction, problem solving and cognitive restructuring.

Первичные конечные точки

  • Disruptive Behaviour Rating Scale [Срок оценки: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.]
  • Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL) [Срок оценки: Pre-treatment; 6-month follow-up; 18-month follow-up.]
Вторичные конечные точки (5)
  • Strength and difficulties questionnaire [Срок оценки: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.]
  • Home Situations Questionnaire [Срок оценки: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.]
  • Social Skills Rating System [Срок оценки: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.]
  • Parent Stress Index [Срок оценки: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.]
  • Pediatric Quality of Life Index [Срок оценки: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.]

Критерии участия

Критерии включения

  • Diagnosed with Oppositional Defiant Disorder
  • Icelandic speaking (child and parent/guardian)

Критерии исключения

  • IQ below 70 (full scale score)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Iceland · 1 центр
  • University of Iceland — Reykjavik

Публикации

  • Njardvik U, Smaradottir H, Ost LG. The Effects of Emotion Regulation Treatment on Disruptive Behavior Problems in Children: A Randomized Controlled Trial. Res Child Adolesc Psychopathol. 2022 Jul;50(7):895-905. doi: 10.1007/s10802-022-00903-7. Epub 2022 Feb 8. PMID 35133557
  • Barkley, R. A. (2013). Defiant children: A clinician's manual for assessment and parent training: Guilford press

Идентификаторы

NCT: NCT06194994 · UI-2023-ODDEMREG

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗