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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Mental Disorder
- Sponsor
- Mental Health Services in the Capital Region, Denmark
- Enrollment
- 170
- Locations
- 2
- Primary Endpoint
- Parenting stress assessed with Parenting Stress Index - Short Form (PSI-4-SF)
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Parenting stress assessed with Parenting Stress Index - Short Form (PSI-4-SF)
Time Frame: 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.
Secondary Outcomes
- 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)