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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 3
- 主要终点
- Parenting stress assessed with Parenting Stress Index - Short Form (PSI-4-SF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Lighthouse MBT Parenting Program (LPP) (Behavioral)
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.
干预措施: Care as usual (CAU) (Behavioral)
结局指标
主要结局
Parenting stress assessed with Parenting Stress Index - Short Form (PSI-4-SF)
时间窗: Baseline, and at 6, 12, and 24 months post randomization
PSI-4-SF is a 36-item questionnaire assessing self-reported levels of parenting stress. The PSI-4-SF consists of three subscales: Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC). A total stress score indicates the overall level of parenting stress as experienced by the parent. Parents rate the degree to which they agree with each statement (SA: Strongly agree, A: Agree, NS: Not sure; D: Disagree, SD: Strongly Disagree). Range: 36-180 with higher scores indicating higher levels of parenting stress.
次要结局
- Psychological adjustment in children assessed with the Strenght and Difficulties Questionnaire - Extended version (SDQ)(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)(Baseline, and at 6, 12, and 24 months post randomization)
- Family functioning assessed with the McMaster Family Assessment Device - General Functioning Scale (FAD-GF).(Baseline, and at 6, 12, and 24 months post randomization)
- Psychiatric symptom severity in parents assessed with the Brief Symptom Inventory (BSI)(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)(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)(Baseline, and at 6, 12, and 24 months post randomization)
- Parenting competence assessed with the Parenting Sense of Competence (PSOC)(Baseline, and at 6, 12, and 24 months post randomization)