A Transdiagnostic Mentalization-based Intervention for Parents With Mental Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lighthouse MBT Parenting Program (LPP), Care as usual (CAU).
- Who it may be relevant to
- Registry conditions: Mental Disorder, Behavior Disorders, Diagnosis, Psychiatric, Diagnosis Dual. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Behavioral 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. - 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. Parents are offered the possibility of bringing their spouse or offspring to one of the sessions.
Primary outcome measures
- Parenting stress assessed with Parenting Stress Index - Short Form (PSI-4-SF) [Time frame: Baseline, and at 6, 12, and 24 months post randomization]
Secondary outcome measures (7)
- Psychological adjustment in children assessed with the Strenght and Difficulties Questionnaire - Extended version (SDQ) [Time frame: 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) [Time frame: Baseline, and at 6, 12, and 24 months post randomization]
- Family functioning assessed with the McMaster Family Assessment Device - General Functioning Scale (FAD-GF). [Time frame: 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) [Time frame: Baseline, and at 6, 12, and 24 months post randomization]
- Parenting competence assessed with the Parenting Sense of Competence (PSOC) [Time frame: Baseline, and at 6, 12, and 24 months post randomization]
- Psychiatric symptom severity in parents assessed with the Brief Symptom Inventory (BSI) [Time frame: 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) [Time frame: Baseline, and at 6, 12, and 24 months post 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Denmark · 2 centers
- Psychotherapeutic Centre Stolpegaard — Gentofte Municipality
- Psychotherapeutic Centre Stolpegård — Gentofte Municipality
Publications
- 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
Identifiers
NCT: NCT06315114 · p-2023-15049 · H-23064491