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NCT Number: NCT06312410

The VIA Family 2.0 - a Family Based Intervention for Families with Parental Mental Illness

VIA Family 2.0 - a Family Based Intervention for families with parental mental illness

Background: Children born to parents with mental illness have consistently been shown to have increased risks for a range of negative life outcomes including increased frequencies of mental disorders, somatic disorders, poorer cognitive functioning, social, emotional and behavioral problems and lower quality of life. Further these children are often overlooked by both society and mental health services, although they represent a potential for prevention and early intervention.

A collaboration between researchers and clinicians from two regions, the Capital Region and the North Region Denmark has been established as the Research Center for Family Based Interventions. The research center is an umbrella for a series of research activities, all focusing on children and adolescents in families with parental mental illness.

Method: A large randomized, controlled trial (RCT) for families with parental mental illness will be conducted in order to evaluate the effect of a two-year multidisciplinary, holistic team intervention (the VIA Family 2.0 team intervention) against treatment as usual (TAU). Inclusion criteria will be biological children 0-17 of parents with any mental disorder treated in the secondary sector at any time of their life and receiving treatment in primary or secondary sector within the previous three years. A total of 870 children or approx. 600 families will be included from two sites. Primary outcomes will be changes in child well being, parental stress, family functioning and quality of the home environment, .

Time plan: The RCT will start including families from March 1st, 2024 to Dec 2025 (or later if needed). All families will be assessed at baseline and at end of treatment, i.e. after 24 months and after 36 months. Baseline data will inform the intervention team about each family's needs, problems, and motivation. TAU will be similar in the two regions, which means three family meetings and option for children to participate in peer groups.

Challenges: final funding is being applied for. Recruitment of families can be challenging but we have decades of experience in conducting research in the field. Since both the target group, their potential problems and the intervention is complex, primary outcome is difficult to determine.

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Key information

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VIA Family 2.0 at BFOR, Gentofte Hospitalsvej 3A, Gentofte Hospital

Copenhagen, Hellerup, 2900, Denmark

Location status: Recruiting

Location contact

Anne Thorup, Phd

CONTACT

[email protected]

+4526210826

Lene F Eplov

CONTACT

Rikke Vinding, MS

CONTACT

[email protected]

anne ranning

CONTACT

jan sandberg

CONTACT

marlene Lauritsen

CONTACT

merete nordentoft

CONTACT

About this study

A detailed study protocol will be published in 2024

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least one of the parents must be living in Capital Region or in Region North, Denmark, and at least one biological child under age 18 must be living with one of the parents. Only biological children of the parent with at mental health problem can be included.
  • The parent with the mental health problems has at some point been diagnosed in the secondary sector and has within the last three years been treated in the primary sector (GP or private psychiatric clinic) or in the secondary sector (hospital psychiatry).
  • Patients with substance abuse can only be included if substance abuse is a secondary diagnosis to another mental illness disorder being treated within the secondary sector during the last three years.
  • All adult participants must give informed consent. Both parents will need to consent in case of shared custody, but do not have to participate if they are reluctant to do so.

Exclusion criteria

  • Not fulfilling inclusion criteria
  • Not giving informed consent
  • Living at Læsø or at Bornholm, Denmark
  • Children placed in care outside of the home fulltime in institution of professional family care (the family is not excluded if the children placed in part time in care outside home or fulltime family care within the family)
  • No risk factors found after baseline assessment (as described in the stepped care model) at baseline - these families can be re-referred if their situation changes.
  • Ongoing intensive family treatment in the municipality (for example staying at an institution for parental evaluation by the authorities)?

Treatment and study plan

VIA Family 2.0

Other

Multidisciplinary team based preventive intervention. For details, please see arm/group description.

Primary outcomes

  1. Change in Strengths and Difficulties Questionnaire (SDQ)

    Time frame: Baseline, end of intervention (24 months) and 36 months follow up.

    Primary outcome for children/adolescents aged 3 years to 17 years will be child's development and wellbeing measured by Strengths and Difficulties Questionnaire (SDQ), which has been used in several other studies, is easy to complete, has Danish norms and is a part of the diagnostic evaluation, Development and Well-Being Assessment, (DAWBA), will be used for psychopathology assessment as well, and can be filled in digitally by the primary caregiver before the clinical assessment. The higher score, the more problems Rated by child from age 11 and by always by parent. A 25 item self-report questionnaire assessing developmental, behavioural and emotional problems completed by children aged 11-17. Items are rated on a three-point Likert scale (0= not true, 1= somewhat true, 2= certainly true).

  2. Change in Bayley-4 Bayley Scales Test for Infant and Toddler Development

    Time frame: Baseline, after 6 months, after 12 months, after 18 months and after 24 months.

    The primary outcome for the youngest children aged 0-2 years will be scores from Bayley-4, a clinical test of the child's cognitive, language, motor and emotional development, conducted by a trained researcher. Scores range from 1-19, the higher score the better functioning

  3. Change in Family Assessment Device - General Function Scale (FAD-GF)

    Time frame: Baseline, end of intervention (24 months), and 36 months follow up

    Primary outcome for the whole family is family functioning rated by the primary caregiver. Family function will be measured by the questionnaire Family Assessment Device, a 12 item questionnaire by the parents and children from age 12 Scale from 1-4. Low score represents better outcome.

  4. Change in Parental Stress Scale (PSS)

    Time frame: Baseline, end of intervention (24 months) and 36 months follow up.

    The primary outcome for the parents is parental stress measured by the Parental Stress Scale (PSS), which is a 18 item parent-reported questionnaire on the quality of experienced stress related to parenting. Score 1-5. A higher score indicates more parental stress.

Secondary outcomes

  1. Change in Home Observation for Measurement of the Environment (HOME)

    Time frame: Baseline, end of intervention (24 months) and 36 months follow up.

    A clinician rated semi-structured interview with both caregiver and child measuring stimulation and support in the home environment (scale 0-60/62 dep on age versions). Higher score represents better outcome.

  2. Change in Parenting and Family Adjustment Scales (PAFAS)

    Time frame: Baseline, end of intervention (24 months), and 36 months follow up

    30 item questionnaire assessing changes in parenting practices, parental adjustment, and family relationships. Scores from 0-90, higher scores indicates poorer parenting or adaptation

  3. Change in Children's Global Assessment Scale (CGAS)

    Time frame: Baseline, end of intervention (24 months) and 36 months follow up

    A clinical rated measurement based on interview to assess general functioning in children. Information is obtained from the child and the caregiver, separately. Scale from 1-100. Higher score indicates better functioning.

  4. Change in Perceived Stress Scale (PSS)

    Time frame: Baseline, end of intervention (24 months) and 36 months follow up.

    10 item questionnaire measuring perceived stress (parents)

  5. Client Satisfaction Scale (CSQ)

    Time frame: End of intervention (24 months)

    Questionnaire with 8 items measuring patient/client .Total scores range from 8 to 32, with the higher number indicating greater satisfaction.

Other outcomes

  1. Change in Ages and Stages Questionnaire:SE-2 (ASQ-SE)

    Time frame: Baseline, after 6 months, after 12 months, after 18 months, after 24 months and 36 months (for children aged 3-5 years)

    Questionnaire measuring child social and emotional development and milestones. Scores range from 0-465, higher scores above cut-off (59) indicate social and emotional problems.

  2. Change in Daily Life Stressor Scale (DLSS)

    Time frame: Baseline, end of intervention (24 months) and 36 months follow up.

    14 item questionnaire measuring child stress, scores range from 0-56, the higher score the higher level of perceived stress

  3. Change in Child and Youth Resilience Measure (CYRM-R)

    Time frame: Baseline, end of intervention (24 months) and 36 months follow up.

    A 12 item self-report questionnaire from age 5 assessing resiliency in children across a number of areas including personal skills, peer support, social skills, physical and psychological caregiving, educational and cultural. Items are rated on a 3- or 5-point Likert scale. Higher scores indicating greater resiliency.

  4. Alarm Distress Baby Scale (ADBB)

    Time frame: Baseline, after 6 month (for children age 0-2 years), after 12 month, after 18 months, after 24 months), and 36 months follow up

    Test for children aged 2-24 months measuring social withdrawal, scores range from 0-32, scores above 4 indicate social withdrawal, the higher score the more severe

  5. Change in Personal and Social Performance Scale (PSP)

    Time frame: Baseline, end of intervention (24 months) and 36 months follow up.

    An interviewer-rated scale assessing the parent's personal and social functioning over four domains (social activities, social relationships, self-care and aggressive behavior).

    Scores range from 1-100, the higher score the better social functioning.

  6. Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS)

    Time frame: Baseline, end of intervention (24 months) and 36 months follow up.

    14 item questionnaire measuring mental wellbeing (non-index parent) scores range from 14 to 70, the higher scores, the better mental wellbeing

  7. Change in Global Assessment of Function - Symptoms (GAF-S)

    Time frame: Baseline, end of intervention (24 months) and 36 months follow up.

    An interviewer-rated scale assessing the Parents Level of Psychiatric Symptoms. GAF-S provides a score from 1-100, with higher scores indicating better outcome.

  8. Change in Kessler Psychological Distress Scale, K10

    Time frame: Baseline, end of intervention (24 months) and 36 months follow up.

    10 item questionnaire on psychological distress with a five-level response scale. Scale from 10-50. Higher score indicating higher level of psychological distress.

  9. Change in General Self-Efficacy Scale (GSE)

    Time frame: Baseline, end of intervention (24 months) and 36 months follow up.

    10 item questionnaire measuring general belief in one's own capabilities. Self-report. Total score is measured. Ranges from 10 to 40. Higher scores indicates better self-efficacy.

  10. Change in Social Provision Scale-short form (SPS)

    Time frame: Baseline, end of intervention (24 months), and 36 months follow up

    The perceived social network can be understood as a resource for resilience and will be measured with Social Provision Scale (SPS) short form, a.10 item questionnaire, with scores ranging from 10-40, the higher score the better social provision perceived

  11. Change in Quality-adjusted life year (EQ-5D)

    Time frame: Baseline, end of intervention (24 months) and 36 months follow up.

    6 item questionnaire, range from 0-100, the higher score the better health

  12. Change in Self-Stigma of Mental Illness Scale - short form (SSMIS-SF)

    Time frame: Baseline, end of intervention (24 months) and 36 months follow up.

    20 item questionnaire on mental health self-stigma (only index parent), in four subscales (stereotype awareness, stereotype agreement, application to self , harm to self-esteem), each scoring from 5 (low) to 45 (high).

  13. Change in The Questionnaire about the Process of Recovery (QPR)

    Time frame: Baseline, end of intervention (24 months) and 36 months follow up.

    15 item questionnaire on the process of recovery on a 4-point scale. Higher scores are indicative of recovery. Only index parent.

  14. General Intelligence Test (RIST)

    Time frame: Baseline

    A clinician rated test measuring general intelligence. The RIST comprises a verbal subtest (Guess What) and a nonverbal subtest (Odd-Item Out).

    Guess What is a classic measure of crystallized intelligence, whereas Odd-Item Out shares characteristics with fluid intelligence.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne A.E. Thorup, Professor

CONTACT

[email protected]

+4526210826

Signe Heuckendorff, PhD

CONTACT

[email protected]

+4561630066

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • Aalborg Psychiatric Hospital
  • Ebbefos Fonden
  • KV Fonden
  • Liljeborgfonden
  • Lundbeck Foundation
  • Novo Nordisk A/S
  • TrygFonden, Denmark

Registry information

Official study title

The VIA Family 2.0 Study: a Randomized Clinical Trial Evaluating Family-based Interventions for Children Born to Parents with Mental Disorders

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 15, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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