NCT06315114

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Mar 2024Apr 2028

First Submitted

Initial submission to the registry

March 5, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

4.1 years

First QC Date

March 5, 2024

Last Update Submit

May 9, 2025

Conditions

Mental DisorderBehavior DisordersDiagnosis, PsychiatricDiagnosis DualSevere Mental DisorderMental IllnessPsychiatric DisorderPsychiatric DiseasePsychiatric Illness

Keywords

Mental disorderParentChildPreventive interventionPreventionIntergenerational transmission

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • 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

  • +2 more secondary outcomes

Other Outcomes (3)

  • Parental mentalizing assessed with the Parental Reflective Functioning Questionnaire (PRFQ)

    Baseline, and at 6, 12, and 24 months post randomization

  • Mind-mindedness assessed with the Representational Mind-Mindedness (MM) interview

    Baseline and at 6 months post randomization

  • Epistemic trust assessed with the Epistemic Trust, Mistrust, and Credulity Ques-tionnaire (ETMCQ)

    Baseline and at 6 months post randomization

Study Arms (2)

Lighthouse MBT Parenting Program (LPP)

EXPERIMENTAL

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)

Care as usual (CAU)

ACTIVE COMPARATOR

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)

Interventions

Lighthouse MBT Parenting Program (LPP)BEHAVIORAL

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.

Lighthouse MBT Parenting Program (LPP)
Care as usual (CAU)BEHAVIORAL

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.

Care as usual (CAU)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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')
  • 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

You may not qualify if:

  • 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
  • Acute suicidal risk or state of crises
  • Lack of informed consent
  • Acute child endangerment
  • Participation in another parenting focused intervention simultaniously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Psychotherapeutic Centre Stolpegaard

Gentofte Municipality, Capital Region, 2820, Denmark

RECRUITING

Psychotherapeutic Centre Stolpegård

Gentofte Municipality, 2820, Denmark

RECRUITING

Related Links

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Sebastian Simonsen, Doctor

    Mental Health Service, Capital Region, Denmark

    STUDY DIRECTOR

Central Study Contacts

Emilie Hestbaek, Msc in Psyc.

CONTACT

+4528302849emilie.hestbaek.jacobsen@regionh.dk

Sebastian Simonsen, Doctor

CONTACT

sebastian.simonsen@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 18, 2024

Study Start

March 11, 2024

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

No plan yet

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Fall 2028
Access Criteria
For more information contact PI

Locations

DK(2)