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Идёт набор NCT06315114

A Transdiagnostic Mentalization-based Intervention for Parents With Mental Disorders

Без фазы С лечением Mental Disorder Behavior Disorders Diagnosis, Psychiatric Diagnosis Dual

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: Lighthouse MBT Parenting Program (LPP), Care as usual (CAU).
Кому может быть актуально
Состояния в реестре: Mental Disorder, Behavior Disorders, Diagnosis, Psychiatric, Diagnosis Dual. Базовые параметры: 18 лет — 65 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

A Transdiagnostic Mentalization-based Intervention (LIGHTHOUSE Parenting Program) Versus Care as Usual for Parents With Mental Disorders in Adult Mental Health Service: a Randomised Clinical Trial

Обзор

The aim of this randomised clinical trial is to evaluate the short and longterm effects of a transdiagnostic mentalization-based intervention (Lighthouse MBT Parenting Program) compared to care as usal (CAU) for parents with a mental disorder in adult mental health service.

Подробное описание

According to the World Health Organization (WHO), 970 million people worldwide suffer from mental disorders, many of whom are parents. Cross-sectional studies indicate that between 15-55% of the patients attending adult mental health service (AMHS) are parents. In Denmark, about 430.000 children have at least one parent with a mental disorder.

Parental mental health problems have a detrimental impact on parenting, leading to long-term negative consequences for their children. Robust evidence shows that children of parents with mental disorders have an elevated risk of various adverse outcomes and events, such as developing a mental disorder themselves and exposure to child maltreatment, compared to children of healthy unaffected parents, suggesting an intergenerational transmission of adversity from parent to child. Mental disorders in parents thus leaves deep traces throughout their children's' lives and entails major socio-economic consequences. Given the high prevalence and substantial burden of parental mental disorders, there is an urgent need for evidence-based interventions targeting the specific needs of this population to prevent the adverse impact on their children. Despite this, the existing services in AMHS for parents with mental disorders are insufficient, and not evidence based. The present trial seeks to fill in this gap.

This is an investigator-initiated single-center, two-arm, parallel group randomized clinical trial testing for superiority of a transdiagnostic mentalization-based intervention (Lighthouse MBT Parenting Program) versus care as usual in 170 parents with various mental disorders. The experimental intervention and active control group intervention are delivered as an add-on to the participants' outpatient treatment.

Participants will be recruited from the outpatient clinics at Psychotherapy Centre Stolpegaard (PCS), Capital Region of Denmark. Participants will be included if they comply with the eligibility criteria. Participants will be assessed at baseline, and at 6, 12, and 24 months follow-up after randomization.

Вмешательства

  • Поведенческое Lighthouse MBT Parenting Program (LPP)
    The experimental group is a manualized transdiagnostic mentalization-based parenting intervention (Lighthouse MBT Parenting Program). This is a 12-week parenting group intervention (weekly session of 2 hours) with one preperatory initial individual session (1 hour) before the group commence.
  • Поведенческое Care as usual (CAU)
    1-2 next of kin sessions (called 'Familiesamtale') is considered the care as usual offered to parents in adult mental health service in the Capital Region of Denmark. Parents are offered the possibility of bringing their spouse or offspring to one of the sessions.

Первичные конечные точки

  • Parenting stress assessed with Parenting Stress Index - Short Form (PSI-4-SF) [Срок оценки: Baseline, and at 6, 12, and 24 months post randomization]
Вторичные конечные точки (7)
  • Psychological adjustment in children assessed with the Strenght and Difficulties Questionnaire - Extended version (SDQ) [Срок оценки: Baseline, and at 6, 12, and 24 months post randomization]
  • Quality of life in parents assessed with the World Health Organization Questionnaire of Life - BREF (WHOQL-BREF) [Срок оценки: Baseline, and at 6, 12, and 24 months post randomization]
  • Family functioning assessed with the McMaster Family Assessment Device - General Functioning Scale (FAD-GF). [Срок оценки: Baseline, and at 6, 12, and 24 months post randomization]
  • Childhood adversity in children assessed with the Adverse Child Experciences Questionnaire (ACE) extended version developed by the Center for Youth Wellness (CYW) [Срок оценки: Baseline, and at 6, 12, and 24 months post randomization]
  • Parenting competence assessed with the Parenting Sense of Competence (PSOC) [Срок оценки: Baseline, and at 6, 12, and 24 months post randomization]
  • Psychiatric symptom severity in parents assessed with the Brief Symptom Inventory (BSI) [Срок оценки: Baseline, and at 6, 12, and 24 months post randomization]
  • Health related quality of life and functioning in parents assessed with the European Quality of life - 5 Dimensions (EQ-5D) [Срок оценки: Baseline, and at 6, 12, and 24 months post randomization]

Критерии участия

Inclusion Criteria exclusive to the Outpatient Clinic

  • Age >18 years
  • Seeking treatment for one of the following non-psychotic disorders according to ICD-10: obsessive-compulsive disorder and anxiety disorders (F40-42), posttraumatic stress disorder (DF43), personality disorders (F60-61), or one of the previous disorders and a drug-or alcohol related disorder (F10-19) (i.e. 'dual diagnosis disorder')

Inclusion Criteria exclusive to the trial:

  • Parent of at least one child aged 0-17 years of age at baseline
  • Fluent i.e., sufficient Danish language skills
  • Parent is living with child or is in regular contact (min. 5 days monthly)
  • Written informed consent

Exclusion Criteria exclusive to the Outpatient Clinic:

  • Possibility of a learning disability (IQ<75)
  • A diagnosis of schizotypal personality disorder or antisocial personality disorder
  • Presence of a comorbid psychiatric disorder that requires specialist treatment elsewhere
  • Concurrent psychotherapeutic treatment outside the clinic

Exclusion Criteria exclusive to the trial:

  • Acute suicidal risk or state of crises
  • Lack of informed consent
  • Acute child endangerment
  • Participation in another parenting focused intervention simultaniously

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
Простое слепое
Основная цель
Лечение

Центры проведения

Дания · 2 центра
  • Psychotherapeutic Centre Stolpegaard — Gentofte Municipality
  • Psychotherapeutic Centre Stolpegård — Gentofte Municipality

Публикации

  • Hestbaek E, Vaever MS, Juul S, Sorensen P, Sleed M, Simonsen S. A transdiagnostic mentalization-based parenting intervention versus care as usual for parents with mental disorders in adult mental health services in Denmark: protocol for a randomized clinical trial. Trials. 2026 Mar 10;27(1):305. doi: 10.1186/s13063-026-09587-6. PMID 41808113

Идентификаторы

NCT: NCT06315114 · p-2023-15049 · H-23064491

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗