A Transdiagnostic Mentalization-based Intervention for Parents With Mental Disorders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Lighthouse MBT Parenting Program (LPP)Experimental treatment 1 intervention
Group B: Care as usual (CAU)Active comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
Baseline, and at 6, 12, and 24 months post randomization
2

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.

Time frame
Baseline, and at 6, 12, and 24 months post randomization
3

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.

Time frame
Baseline, and at 6, 12, and 24 months post randomization
4

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.

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

Other outcomes

1

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.

Time frame
Baseline, and at 6, 12, and 24 months post randomization
2

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.

Time frame
Baseline and at 6 months post randomization
3

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.

Time frame
Baseline and at 6 months post randomization

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