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Набор скоро начнётся NCT07143383

CAMHS and Social Prescribing Applications

Без фазы С лечением Mental Health

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: Social Prescribing, Signposting.
Кому может быть актуально
Состояния в реестре: Mental Health. Базовые параметры: 11 лет — 18 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Background: Social prescribing (SP) is a mechanism for linking patients with non-medical forms of community support and has demonstrated mental health benefits for adults and young people (YP). However, SP is predominantly based in primary care, which limits accessibility for YP who typically engage less with this setting. Within CAMHS (Child and Adolescent Mental Health Services), SP has only recently begun to be trialed, mainly as a pre-treatment option while waiting for care. The CASPA study will pilot a novel SP pathway embedded after the start of psychological treatment in CAMHS, aiming to test its feasibility, acceptability, and potential impact on mental health and wellbeing through a randomized controlled trial. Methods: CASPA is a two-group (intervention vs. active control) parallel randomized pilot study with YP as the unit of randomization. A total of 120 YP aged 11-18, who have started psychological treatment for emotional difficulties in one of three CAMHS sites in England, will be recruited. Participants in the intervention group will receive a co-produced, person-centered SP pathway involving up to six sessions with a trained Link Worker (LW). These sessions will help identify 'what matters to them' and connect YP with locally mapped community activities and support (e.g. arts, sports, volunteering). Participants in the control group will receive signposting to the same community resources via a leaflet from CAMHS staff or researchers. Quantitative data will be collected at baseline, 3-month and 6-month follow-up, including measures of resilience, mental health, wellbeing, service use, and quality of life. Primary outcomes include feasibility, acceptability, and appropriateness of the intervention, assessed through validated measures and participation metrics, alongside any evidence of impact. Qualitative interviews with YP, CAMHS staff, and LWs will explore implementation experiences, barriers, facilitators, and mechanisms of impact. Discussion: The CASPA study will generate preliminary evidence regarding the feasibility, acceptability, and appropriateness of offering SP after psychological treatment within CAMHS has started. It will also provide early insights into whether this approach can improve outcomes for YP with emotional difficulties. Findings will inform decisions on the design and justification for a future full-scale clinical and cost-effectiveness trial.

Вмешательства

  • Поведенческое Social Prescribing
    SP is a person-centered approach to wellbeing involving the co-development of a non-clinical prescription, between an individual (i.e. young person) and Link Workers (LWs), based on the perceived difficulties for the referral and the YPs values, needs and preferences. LWs have a good knowledge of their local areas, via community asset mapping and networking, allowing them to connect individuals with different types of available support and activities. Typically, SP ranges from 6-12 sessions (ave
  • Поведенческое Signposting
    Those in the control group will receive signposting to activities and local sources of support in their communities. This will consist of a CAMHS clinician or researcher meeting with YP identified and providing them with a leaflet detailing the same local sources of support identified by the LW from asset mapping.

Первичные конечные точки

  • Acceptability (young people) [Срок оценки: 3 and 6 months]
Вторичные конечные точки (11)
  • Acceptability (CAMHS Staff and LWs) [Срок оценки: 6 months]
  • Feasibility (young people) [Срок оценки: Post intervention (t least 3 months)]
  • Feasibility (CAMHS Staff and LWs) [Срок оценки: 6 months]
  • Appropriateness (young people) [Срок оценки: 3 and 6 months]
  • Appropriateness (CAMHS Staff and LWs) [Срок оценки: 6 months]
  • Wellbeing: ONS Personal Wellbeing Questions [Срок оценки: Baseline, 3 and 6 months]
  • Depression: Short Mood and Feelings Questionnaire. [Срок оценки: Baseline, 3 and 6 months]
  • Anxiety: Generalised Anxiety Disorder-7 Questionnaire. [Срок оценки: Baseline, 3 and 6 months]
  • Stress: Perceived Stress Scale-4. [Срок оценки: Baseline, 3 and 6 months]
  • Service Use: Short-Client Service Receipt of Inventory. [Срок оценки: Baseline, 3 and 6 months]
  • Quality of Life: Child Health Utility-9D. [Срок оценки: Baseline, 3 and 6 months]

Критерии участия

Eligibility criteria

Критерии включения

(i) CAMHS

  • Wish to participate in CASPA
  • Located in England

(ii) YP Participants

  • Aged between 11 to 18 years
  • Capacity to give assent (if under 16), or
  • Capacity to give informed consent (if aged 16 or over or has Gillick competence if aged under 16)
  • Have started psychological treatment in CAMHS for an emotional difficulty (e.g. depression, anxiety)

(iii) Parent/Guardian Participants

  • Aged 18 or over
  • Capacity to give informed consent for YP involvement in CASPA (when the YP is aged between 11-15 and lacks Gillick competence)

(iv) CAMHS staff and LWs:

  • Aged 18 or over
  • Capacity to give informed consent to participate in CASPA

Exclusion criteria (i) YP participants

  • YP with emotional difficulties put on an enhanced specialist pathway due to another severe and complex difficulty which requires intensive input (e.g. anorexia, psychosis or severe and complex difficulties (as judged by the assessing clinician))

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
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. PMID 28851459
  • Stevens K. Developing a descriptive system for a new preference-based measure of health-related quality of life for children. Qual Life Res. 2009 Oct;18(8):1105-13. doi: 10.1007/s11136-009-9524-9. Epub 2009 Aug 20. PMID 19693703
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. PMID 16717171
  • PISA (2022): PISA 2022 Assessment and Analytical Framework. OECD; 2023. doi:10.1787/dfe0bf9c-en
  • ONS (2003). Personal well-being in the UK: April 2022 to March 2023. https://www.ons.gov.uk/peoplepopulationandcommunity/wellbeing/bulletins/measuringnationalwellbeing/april2022tomarch2023
  • MSC (2011): UCL Social Research Institute Centre for Longitudinal Studies (2011). MCS Age 11 Child Self-Completion Questionnaire: England.
  • EBPU. Session Feedback Questionnaire . London; 2012. Available: https://www.corc.uk.net/media/1405/sfq_questionnaire.pdf
  • MacDermott, S. T., Gullone, E., Allen, J. S., King, N. J., & Tonge, B. (2010). The emotion regulation index for children and adolescents (ERICA): A psychometric investigation. Journal of Psychopathology and Behavioral Assessment, 32(3), 301-314. https://doi.org/10.1007/s10862-009-9154-0

Идентификаторы

NCT: NCT07143383 · 177012

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗