A Transdiagnostic Mentalization-based Intervention for Parents With Mental Disorders (LIGHTHOUSE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Illness; Behavior Disorders; Psychiatric Disorder; Mental Disorder; Severe Mental Disorder; Psychiatric Illness; Diagnosis, Psychiatric; Psychiatric Disease; Diagnosis Dual
• Intervention / Treatment: Behavioral: Lighthouse MBT Parenting Program (LPP); Behavioral: Care as usual (CAU)

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.

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emilie Hestbaek, Msc in Psyc.; Phone Number: +4528302849; Email: emilie.hestbaek.jacobsen@regionh.dk
• Study Contact Backup: Name: Sebastian Simonsen, Doctor; Email: sebastian.simonsen@regionh.dk

Study Locations

• Denmark
  • Gentofte, Denmark, 2820
    • Recruiting
    • Psychotherapeutic Centre Stolpegård
    • Contact: Sebastian Simonsen, Doctor; Email: sebastian.simonsen@regionh.dk
    • Contact: Emilie Hestbaek, Msc in Psyc; Phone Number: +4528302849; Email: emilie.hestbaek.jacobsen@regionh.dk
  • Capital Region
    • Gentofte, Capital Region, Denmark, 2820
      • Recruiting
      • Psychotherapeutic Centre Stolpegaard
      • Contact: Emilie Hestbaek; Phone Number: +4528302849; Email: emilie.hestbaek.jacobsen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting stress assessed with Parenting Stress Index - Short Form (PSI-4-SF)	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.	Baseline, and at 6, 12, and 24 months post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological adjustment in children assessed with the Strenght and Difficulties Questionnaire - Extended version (SDQ)	SDQ is a 25-item questionnaire assessing parent-reported child emotional and behavioural problems. The SDQ has five scales (scored 0-10); emotional problems, conduct problems, hyperactivity, peer problems and pro-social scale. The scales are combined (excluding the pro-social scale) into a 'total difficulties' score (Range: 0-40, with higher scores indicating more problems). The items on the overall distress and impairment can be summed to generate an impact score (Range: 0-10), indicating the need for assessment and possible intervention. Parents rate the degree to which they agree with each statement (NT: Not true, ST: Somewhat true, CT: Certainly true). Higher scores indicate more problems or more functional impairment.	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)	WHOQL-BREF is a 26-item questionnaire assessing self-reported quality of life. The instrument measures an individual's overall quality of life and general health and four health dimensions: Physical health, psychological, social relationships, and environment. The domain scores are scaled in a positive direction with higher scores indicating a higher quality of life. The two domains assessing psychological health (6 items) and social relationsships (3-items) and the measure of the overall quality of life and general health (2 items) will be used.	Baseline, and at 6, 12, and 24 months post randomization
Family functioning assessed with the McMaster Family Assessment Device - General Functioning Scale (FAD-GF).	The FAD is a questionnaire assessing self-reported perceptions of the parent's current family relationships. It consists of five subscales: problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, and general functioning. Parents rate each statement on a 4-point scale (SA: Strongly agree, A: Agree, D: Disagree, SD: Strongly Disagree). Only the general functioning (6-items) subscale will be used.Range: 6-24, with higher scores indicating more functional impairment.	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)	ACE CYW is questionnaire assessing parent-reported childhood adversity in children and adolescents. The instrument is comprised of two sections: Section 1 consists of the traditional ten ACEs covering exposure to childhood psychological, physical, and sexual abuse as well as household dysfunction, including domestic violence, substance use, and incarceration. Section 2 includes seven (CYW ACE-Q Child) or nine (CYW ACE-Q Teen) items assessing for exposure to additional early life stressors, including involvement in the Foster Care system, bullying, loss of parent or guardian due to death, deportation or migration, medical trauma, exposure to community violence, and discrimination. Parents are asked to how many categories apply to their child (i.e. they do not specificy which categories applies). Parents tally the number for each section, and report the total number, thus resulting in two total scores. Higher scores indicates exposure to more adverse events.	Baseline, and at 6, 12, and 24 months post randomization
Parenting competence assessed with the Parenting Sense of Competence (PSOC)	PSOC is a 16-item questionnaire assessing self-reported parenting competence It consists of 2 subscales: Parental satisfaction and parental self-efficacy. Parents rate each item on a 6-point scale.ossible scores range from 10 to 60 for Efficacy and 6 to 36 for Satisfaction. Lower scores may indicate a parent's uncertainty about whether they have the knowledge or skills required to be an effective parent.	Baseline, and at 6, 12, and 24 months post randomization
Psychiatric symptom severity in parents assessed with the Brief Symptom Inventory (BSI)	BSI is a 53-item questionnaire assessing self-reported severity of psychiatric symptoms adapted from the Symptom Checlist Revised (SCL-90-R). it covers 9 symptom dimensions: Somatization, Obsession-Compulsion, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation and Psychoticism; and three global indices of distress: Global Severity Index, Positive Symptom Distress Index, and Positive Symptom Total. The global indices measure current or past level of symptomatology, intensity of symptoms, and number of reported symptoms, respectively. Parents rate each statement on a 5-point scale ranging from 0 (not at all ) to 4 (extremely). Range: 0-212, with higher scores indicating higher symptom severity	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)	EQ-5D is a 5-item questionnaire assessing health related quality of life and level of functioning. Parents select one out of three statements within each of five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Higher scores indicates better quality of life. The statements are complemented by a visual analog scale in which parents are asked to rate the health ranging form 0 (worst imaginable health) to 100 (best imaginale health)	Baseline, and at 6, 12, and 24 months post randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental mentalizing assessed with the Parental Reflective Functioning Questionnaire (PRFQ)	PRFQ is a 18-item questionnaire assessing self-reported parental mentalizing.Higher scores on the PM indicates impaired mentalizing, while high and low scores on IC and CMS indicates impaired mentalizing.	Baseline, and at 6, 12, and 24 months post randomization
Mind-mindedness assessed with the Representational Mind-Mindedness (MM) interview	In the MM interview, parents are asked to describe their child. The response is taped and verbatim transcribed. The description is the coded following the guidelines from the coding manual (Meins & Fernyhough, 2015). Total score range: 0-150, with higher scores indicating better mentalizing.	Baseline and at 6 months post randomization
Epistemic trust assessed with the Epistemic Trust, Mistrust, and Credulity Ques-tionnaire (ETMCQ)	ETMCQ is a 18-item questionnaire assessing self-reported trust in others. Higher scores on trust indicates higher levels of trust, while higher scores on mistrust and credulity indicates epistemic mistrust.	Baseline and at 6 months post randomization

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborators: University of Copenhagen
• Investigators: Study Director: Sebastian Simonsen, Doctor, Mental Health Service, Capital Region, Denmark

Publications and helpful links

Helpful Links

• Profile of project leader
• Description of trial

Study record dates

Study Major Dates

• Study Start (Estimated): March 11, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Child; Prevention; Parent; Mental disorder; Intergenerational transmission; Preventive intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Disease; Psychotic Disorders; Problem Behavior; Mental Disorders
• Other Study ID Numbers: p-2023-15049; H-23064491 (Other Identifier: Regional Committee of Health Research Ethics (VEK))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: No plan yet
• IPD Sharing Time Frame: Fall 2028
• IPD Sharing Access Criteria: For more information contact PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No