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Идёт набор NCT05603000

Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties

Без фазы С лечением Anxiety Depression Behavior Problem

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: Emotion Focused Family Therapy.
Кому может быть актуально
Состояния в реестре: Anxiety, Depression, Behavior Problem. Базовые параметры: 7 лет — 15 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Randomized Controlled Trial of Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties

Обзор

Emotion Focused Family Therapy (EFFT) is a promising intervention that aims to teach parents advanced skills to support their child's development of emotion skills and increase their adaptive behaviours, potentially leading to improvements in their child's psychological functioning and family functioning more broadly. This randomized controlled trial (RCT; EFFT vs waitlist control) will (1) test the efficacy of a 6-week group EFFT program on parent and child outcomes and (2) examine maintenance of treatment gains up to four months post-intervention.

Подробное описание

This randomized controlled trial (RCT) will test the efficacy of a 6-week Emotion Focused Family Therapy (EFFT) group program on parent and child outcomes, compared to a waitlist control. Families will be randomized to either the EFFT group treatment or a waitlist. The RCT will evaluate changes in parent functioning, child functioning, and parent-child relationship functioning. A 4-month follow-up will test whether any changes from pre-to-post intervention are maintained at 4 months.

The RCT will also test proposed mechanisms of change (parent-child relationship quality, family functioning) and moderators of treatment effectiveness (parental stress).

Вмешательства

  • Поведенческое Emotion Focused Family Therapy
    The Emotion Focused Family Therapy (EFFT) intervention for this study will be delivered to groups of four to ten parents over six weekly sessions of two hours each. The goal of EFFT is to teach and empower parents to coach their child to process the emotions at the source of their mental health symptoms, to increase their child's adaptive behaviours, and to repair emotional injuries within the parent-child relationship. EFFT also targets parents' own emotional challenges that may prevent them fr

Первичные конечные точки

  • Change in parental psychopathology symptoms at 6 weeks and 4 months [Срок оценки: Change at 6 weeks; Change at 4 months]
  • Change in child psychopathology symptoms at 6 weeks and 4 months [Срок оценки: Change at 6 weeks; Change at 4 months]
  • Change in parental emotion regulation at 6 weeks and 4 months [Срок оценки: Change at 6 weeks; Change at 4 months]
  • Change in child emotion regulation at 6 weeks and 4 months [Срок оценки: Change at 6 weeks; Change at 4 months]
  • Change in parent-child co-regulation at 6 weeks and 4 months [Срок оценки: Change at 6 weeks; Change at 4 months]
  • Change in parent-child relationship functioning at 6 weeks and 4 months [Срок оценки: Change at 6 weeks; Change at 4 months]
Вторичные конечные точки (8)
  • Change in parental emotion socialization at 6 weeks and 4 months [Срок оценки: Change at 6 weeks; Change at 4 months]
  • Change in parental emotion blocks at 6 weeks and 4 months [Срок оценки: Change at 6 weeks; Change at 4 months]
  • Change in parental self-efficacy at 6 weeks and 4 months [Срок оценки: Change at 6 weeks; Change at 4 months]
  • Fidelity of EFFT program [Срок оценки: Throughout intervention over 6 weeks]
  • Change in perceived parental stress at 6 weeks and 4 months [Срок оценки: Change at 6 weeks; Change at 4 months]
  • Parental treatment satisfaction [Срок оценки: At 6 weeks]
  • Parent-reported change in familial functioning at 6 weeks and 4 months [Срок оценки: Change at 6 weeks; Change at 4 months]
  • Change in physiological arousal at 6 weeks and 4 months [Срок оценки: Change at 6 weeks; Change at 4 months]

Критерии участия

Критерии включения

  • Parent of child aged 7 to 15 years old with anxiety, depression, or behavioural challenges
  • Parent of child is willing to participate in intervention
  • Parent is living at home with the child

Критерии исключения

  • Parent or child not proficient enough in speaking/understanding English to complete measures or EFFT intervention components
  • Parent or child with a severe mental health disorder (e.g., active suicidality and psychosis) is not considered suitable for the trial intervention due to the clinical need for immediate intervention
  • Parent or child is actively receiving, or due to receive, intensive psychological intervention focused on cognitive and/or behavioural strategies to intervene with emotional or behavioural difficulties
  • Parent or child has any disabilities in language, speech or hearing that would interfere with their completion of the EFFT and measures
  • Parent or child are allergic to adhesive electrode gel use in some tasks (i.e., sodium chloride)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • Maplewoods Centre for Family Therapy and Child Psychology, University of Guelph — Guelph

Публикации

  • National Research Council (US) and Institute of Medicine (US) Committee on the Prevention of Mental Disorders and Substance Abuse Among Children, Youth, and Young Adults: Research Advances and Promising Interventions; O'Connell ME, Boat T, Warner KE, editors. Preventing Mental, Emotional, and Behavioral Disorders Among Young People: Progress and Possibilities. Washington (DC): National Academies P PMID 20662125
  • Ogundele MO. Behavioural and emotional disorders in childhood: A brief overview for paediatricians. World J Clin Pediatr. 2018 Feb 8;7(1):9-26. doi: 10.5409/wjcp.v7.i1.9. eCollection 2018 Feb 8. PMID 29456928
  • Campbell SB, Shaw DS, Gilliom M. Early externalizing behavior problems: toddlers and preschoolers at risk for later maladjustment. Dev Psychopathol. 2000 Summer;12(3):467-88. doi: 10.1017/s0954579400003114. PMID 11014748
  • Freuchen A, Kjelsberg E, Lundervold AJ, Groholt B. Differences between children and adolescents who commit suicide and their peers: A psychological autopsy of suicide victims compared to accident victims and a community sample. Child Adolesc Psychiatry Ment Health. 2012 Jan 4;6:1. doi: 10.1186/1753-2000-6-1. PMID 22216948
  • Reef J, Diamantopoulou S, van Meurs I, Verhulst FC, van der Ende J. Developmental trajectories of child to adolescent externalizing behavior and adult DSM-IV disorder: results of a 24-year longitudinal study. Soc Psychiatry Psychiatr Epidemiol. 2011 Dec;46(12):1233-41. doi: 10.1007/s00127-010-0297-9. Epub 2010 Oct 10. PMID 20936464
  • Buckholdt KE, Parra GR, Jobe-Shields L. Intergenerational Transmission of Emotion Dysregulation Through Parental Invalidation of Emotions: Implications for Adolescent Internalizing and Externalizing Behaviors. J Child Fam Stud. 2014 Feb 1;23(2):324-332. doi: 10.1007/s10826-013-9768-4. PMID 24855329
  • Cao M, Powers A, Cross D, Bradley B, Jovanovic T. Maternal emotion dysregulation, parenting stress, and child physiological anxiety during dark-enhanced startle. Dev Psychobiol. 2017 Dec;59(8):1021-1030. doi: 10.1002/dev.21574. Epub 2017 Oct 13. PMID 29027660
  • Fabes RA, Leonard SA, Kupanoff K, Martin CL. Parental coping with children's negative emotions: relations with children's emotional and social responding. Child Dev. 2001 May-Jun;72(3):907-20. doi: 10.1111/1467-8624.00323. PMID 11405590

Идентификаторы

NCT: NCT05603000 · EFFT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗