Clinical trial NCT06315114: A Transdiagnostic Mentalization-based Intervention for Parents With Mental Disorders
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Disorder
Behavior Disorders
Diagnosis, Psychiatric
Diagnosis Dual
Severe Mental Disorder
Mental Illness
Psychiatric Disorder
Psychiatric Disease
Psychiatric Illness
Keywords: Mental disorder
Parent
Child
Preventive intervention
Prevention
Intergenerational transmission
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2024-03-18
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parenting stress assessed with Parenting Stress Index - Short Form (PSI-4-SF)
timeFrame: Baseline, and at 6, 12, and 24 months post randomization
Secondary outcomes:
measure: Psychological adjustment in children assessed with the Strenght and Difficulties Questionnaire - Extended version (SDQ)
timeFrame: Baseline, and at 6, 12, and 24 months post randomization
measure: Quality of life in parents assessed with the World Health Organization Questionnaire of Life - BREF (WHOQL-BREF)
timeFrame: Baseline, and at 6, 12, and 24 months post randomization
measure: Family functioning assessed with the McMaster Family Assessment Device - General Functioning Scale (FAD-GF).
timeFrame: Baseline, and at 6, 12, and 24 months post randomization
measure: Childhood adversity in children assessed with the Adverse Child Experciences Questionnaire (ACE) extended version developed by the Center for Youth Wellness (CYW)
timeFrame: Baseline, and at 6, 12, and 24 months post randomization
measure: Parenting competence assessed with the Parenting Sense of Competence (PSOC)
timeFrame: Baseline, and at 6, 12, and 24 months post randomization
measure: Psychiatric symptom severity in parents assessed with the Brief Symptom Inventory (BSI)
timeFrame: Baseline, and at 6, 12, and 24 months post randomization
measure: Health related quality of life and functioning in parents assessed with the European Quality of life - 5 Dimensions (EQ-5D)
timeFrame: Baseline, and at 6, 12, and 24 months post randomization
Other outcomes:
measure: Parental mentalizing assessed with the Parental Reflective Functioning Questionnaire (PRFQ)
timeFrame: Baseline, and at 6, 12, and 24 months post randomization
measure: Mind-mindedness assessed with the Representational Mind-Mindedness (MM) interview
timeFrame: Baseline and at 6 months post randomization
measure: Epistemic trust assessed with the Epistemic Trust, Mistrust, and Credulity Ques-tionnaire (ETMCQ)
timeFrame: Baseline and at 6 months post randomization
Locations:
city: Gentofte
country: Denmark
facility: Psychotherapeutic Centre Stolpegaard
state: Capital Region
city: Gentofte
country: Denmark
facility: Psychotherapeutic Centre Stolpegård
Study officials:
affiliation: Mental Health Service, Capital Region, Denmark
name: Sebastian Simonsen, Doctor
role: STUDY_DIRECTOR
References: