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Набор по приглашению NCT07339696

Danish Access to Support and Help (DASH): Increasing Access to an Evidence-based Intervention for Children With ADHD and Their Parents

Наблюдательное ADHD - Attention Deficit Disorder With Hyperactivity Attention Concentration Difficulty

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: New Forest Parenting Programme.
Кому может быть актуально
Состояния в реестре: ADHD - Attention Deficit Disorder With Hyperactivity, Attention Concentration Difficulty. Базовые параметры: 3 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
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

DANISH TITLE: Projekt Rette hjælp Til børn Med ADHD Eller Udfordringer Med Uro og Koncentration

Обзор

The aim of this study is to devise implementation strategies for the New Forest Parenting Programme (NFPP) to support a community implementation model (NFPP-CIM) and test its feasibility and acceptability for parents and stakeholders.

Подробное описание

Background Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition associated with substantial individual and societal costs. Although effective behavioural interventions such as the New Forest Parenting Programme (NFPP) are available, access to evidence-based parent training remains limited in community settings. The current study addresses the gap between research and practice by supporting the implementation of NFPP within local Child and Family Services in Danish municipalities.

Purpose and Rationale The primary aim of this study is to develop and evaluate the feasibility and acceptability of a community implementation model for the New Forest Parenting Programme (NFPP-CIM). The project is designed as a Hybrid Type II feasibility study, focusing on both implementation processes and perceived effects in real-world community contexts. The study seeks to determine whether the NFPP-CIM can support feasible, acceptable, and sustainable delivery of NFPP by local practitioners, thereby informing future large-scale implementation.

Objectives

The study objectives are guided by the Expert Recommendations for Implementing Change (ERIC) framework and include:

To develop an NFPP Community Implementation Model (NFPP-CIM) tailored to Danish municipal contexts.

To assess the feasibility and acceptability of the NFPP-CIM among families of children with ADHD or difficulties related to attention and activity regulation, as well as among community-level stakeholders (e.g. practitioners and managers).

To explore perceived changes in family functioning and everyday life associated with participation in NFPP-CIM, and to consider how these experiences align with findings previously reported in specialist settings.

Study Design and Setting The study will employ a pre-post hybrid effectiveness-implementation design. NFPP-CIM will be delivered in three Danish municipalities by trained community practitioners in collaboration with local child and family services. Quantitative and qualitative data will be collected to examine implementation outcomes and user experiences. The project emphasizes co-creation, user participation, and interagency collaboration to strengthen local ownership and sustainability.

Implementation Outcomes Consistent with the study's implementation focus, feasibility and acceptability constitute central outcomes of the project.

Feasibility of implementing the NFPP-CIM will be assessed using quantitative implementation indicators, including:

Recruitment rate, defined as the proportion of eligible families who consent to participate (assessed from initial contact to enrollment).

Completion rate, defined as the proportion of enrolled families who complete the intervention and post-intervention assessment.

Practitioner adherence, defined as fidelity to the NFPP-CIM manual, assessed through session checklists completed throughout the intervention period (approximately 16 weeks).

Acceptability of the NFPP-CIM will be examined using qualitative methods, including semi-structured interviews and brief open-ended satisfaction questionnaires completed by parents. These data will explore the perceived practicality, usefulness, and overall experience of participating in the intervention. Acceptability data will be collected at post-intervention, within six weeks after completion of the programme.

Expected Outcomes and Significance Findings will provide insight into how NFPP can be effectively implemented and scaled up in community settings. Specifically, the study will inform refinement of NFPP training models for local practitioners, strategies for user involvement, and approaches to sustaining cross-sector collaboration. By focusing on real-world feasibility and stakeholder experiences, the study aims to bridge the gap between evidence-based ADHD interventions and community-based practice and to support improved access to high-quality services for families.

Вмешательства

  • Поведенческое New Forest Parenting Programme
    Parent training for children who has difficulties with attention and activity or ADHD

Первичные конечные точки

  • Primary Outcome (exploratory clinical signal): ADHD Rating Scale-IV (ADHD-RS-IV) Danish Version - parent ratings [Срок оценки: Change in ADHD symptoms measured by ADHD-RS from baseline to post-intervention. I.e. From T1: enrolment (baseline) to T2: T2 (End of treatment): approximately 16 weeks after T1 to T3 (Follow-up): approximately 36 weeks after T2.]
Вторичные конечные точки (3)
  • The Strengths and Difficulties Questionnaire (SDQ) - Danish parent version [Срок оценки: Change in SDQ scores from baseline (T1) at enrollment, to post-intervention (T2) approximately 16 weeks after T1, and to follow-up (T3) approximately 36 weeks after T2.]
  • The Parenting Sense of Competence Scale (PSOC) Danish version - parent ratings [Срок оценки: Change in PSOC scores from baseline (T1) at enrollment, to post-intervention (T2) approximately 16 weeks after T1, and to follow-up (T3) approximately 36 weeks after T2.]
  • Family Strain Index (FSI) - parent ratings [Срок оценки: Change in FSI scores from baseline (T1) at enrollment, to post-intervention (T2) approximately 16 weeks after T1, and to follow-up (T3) approximately 36 weeks after T2.]

Критерии участия

Критерии включения

  • Families receiving services through municipal child and family clinics in Denmark
  • Child aged 3-12 years
  • Parent-perceived difficulties with attention and activity regulation, including those with a diagnosis or suspected diagnosis of ADHD.
  • All custodial parents willing and able to provide informed consent
  • Parents interested in participating in the New Forest Parenting Programme - Community Implementation Model (NFPP-CIM)

Критерии исключения

  • Families not receiving services through municipal child and family clinics
  • Parents unable to provide informed consent
  • Families unable to participate in the intervention due to severe child or family circumstances that preclude engagement (e.g. acute crisis requiring alternative services, Parents or children with severe mental or physical illness that would prevent active participation in the intervention)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Дания · 1 центр
  • Forskningsafdelingen - Børne- og Ungdomspsykiatrisk Afdeling, Psykiatrien-Skejby — Aarhus

Публикации

  • Alexandre, J.L., et al., The ADHD rating scale-IV preschool version: Factor structure, reliability, validity, and standardisation in a Danish community sample. Research in Developmental Disabilities, 2018. 78: p. 125-135. Arnfred, J., et al., Danish norms for the Strengths and Difficulties Questionnaire. Danish medical journal, 2019. 66(6). Borrelli, B., The assessment, monitoring, and enhancement

Идентификаторы

NCT: NCT07339696 · 152531 · 152531

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗