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Набор скоро начнётся NCT07463001

Optimization and Testing Effectiveness of a Collaborative Intervention for School Attendance Problems in Norwegian Municipalities

Без фазы С лечением School Attendance Problems

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: Back2School.
Кому может быть актуально
Состояния в реестре: School Attendance Problems. Базовые параметры: 9 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
Норвегия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

In this study we will investigate the effects of an intervention called Back2School, revised and adapted for Norwegian conditions on school attendance. A total of 240 participants will be recruited. All participants who have been enrolled will receive the intervention. Half of the participants will receive the intervention without delay (the experiment group), and the other half will receive it following a 13-week period (the control group). Following consent, screening for eligibility and randomization, the intervention will start with an assessment related to the individual participant and condition at the participants' school. Based on this a shared understanding and an intervention plan is developed. Over a 13-week period the youth, the family and the school, work together guided by the municipal team to increase attendance and solve problems related to this. Assessments will be carried out after the intervention and 6 months later.

Вмешательства

  • Поведенческое Back2School
    The revised Back2S school manual consists of an initial assessment, a case formulation conference, 16 sessions and 3 meetings with different participants (parents, youth, school personnel) over 13 weeks. There is a booster session 12 weeks after the final session and one 24 weeks after the final session.

Первичные конечные точки

  • School attendance [Срок оценки: Direct: Avg at Baseline, 2 weeks at end (13 weeks from baseline), 2 weeks at 6 months (37 w from baseline) Delayed: Avg at baseline, 2 weeks before start (13 w from baseline) 2 weeks at end (28 w from baseline), 2 weeks at 6 months (54 w from baseline)]
  • General functioning [Срок оценки: Direct start group: Will be measured at Baseline (T1), Week 15 from baseline (T2), Week 37 from baseline (T3) Delayed access group: Baseline (T1), Week 15 from Baseline (T1a), Week 29 from baseline (T2), Week 54 from baseline (T3)]
Вторичные конечные точки (3)
  • Change in Quality of life [Срок оценки: Direct start group: Will be measured at Baseline (T1), Week 15 from baseline (T2), Week 37 from baseline (T3) Delayed access group: Baseline (T1), Week 15 from Baseline (T1a), Week 29 from baseline (T2), Week 54 from baseline (T3)]
  • Change in symptoms of anxiety [Срок оценки: Direct start group: Will be measured at Baseline (T1), Week 15 from baseline (T2), Week 37 from baseline (T3) Delayed access group: Baseline (T1), Week 15 from Baseline (T1a), Week 29 from baseline (T2), Week 54 from baseline (T3)]
  • Change in symptoms of Depression [Срок оценки: Direct start group: Will be measured at Baseline (T1), Week 15 from baseline (T2), Week 37 from baseline (T3) Delayed access group: Baseline (T1), Week 15 from Baseline (T1a), Week 29 from baseline (T2), Week 54 from baseline (T3)]

Критерии участия

Критерии включения

  • Participants must be between the ages of 9 and 15 at the time of enrollment.
  • Participants must have less than 80% attendance for the last 12 weeks of school at the time of screening.
  • At least one parent has to talk and understand Norwegian.
  • At least one parent has to be motivated to participate.
  • The school must agree to participate in the intervention

Критерии исключения

1 The participant has a known diagnosis of autism-spectrum disorder, psychosis, and/or eating disorder.

2\. Participant needs acute psychiatric intervention.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Норвегия · 4 центра
  • NORCE, RKBU Vest — Bergen
  • Pilar, Regionsenter for barn og unges psykiske helse — Oslo
  • UIT, RKBU Nord — Tromsø
  • Norwegian University of Scinece and Technology — Trondheim

Идентификаторы

NCT: NCT07463001 · 353222 · 907476 · 658505

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗