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

Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06312410
• Other study ID #: H-23067714
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2024
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Anne A.E. Thorup, Professor
• Phone: +4526210826
• Email: Anne.Amalie.Elgaard.Thorup[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

A detailed study protocol will be published in 2024

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1452
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 17 Years

Eligibility

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)?

Related Conditions & MeSH terms

• Child
• Child of Impaired Parents
• Mental Disorder
• Mental Disorders
• Parents
• Preventive Health Services
• Psychotic Disorders

Intervention

Other:
• VIA Family 2.0
Multidisciplinary team based preventive intervention. For details, please see arm/group description.

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Aalborg Psychiatric Hospital, Ebbefos Fonden, KV Fonden, Liljeborgfonden, Lundbeck Foundation, Novo Nordisk A/S, TrygFonden, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Vineland Adaptive Behavior Scales-Second Edition (Vineland-II)	A clinician rated semi-structured interview with the primary caregiver about the child measuring the child's development and functioning.	Baseline, end of intervention (24 months) and 36 months follow up.
Other	Change in children's quality of life (KIDSCREEN-27)	A 27 item self-report questionnaire assessing health related Quality of Life completed by the child from age 8. Each item is rated on a 5-point Likert scale. A higher score indicates a better quality of life	Baseline, end of intervention (24 months) and 36 months follow up.
Other	Change in Ages and Stages Questionnaire:SE-2 (ASQ-SE)	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.	Baseline, after 6 months, after 12 months, after 18 months, after 24 months and 36 months (for children aged 3-5 years)
Other	Change in Daily Life Stressor Scale (DLSS)	14 item questionnaire measuring child stress, scores range from 0-56, the higher score the higher level of perceived stress	Baseline, end of intervention (24 months) and 36 months follow up.
Other	Change in Child and Youth Resilience Measure (CYRM-R)	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.	Baseline, end of intervention (24 months) and 36 months follow up.
Other	Alarm Distress Baby Scale (ADBB)	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	Baseline, after 6 month (for children age 0-2 years), after 12 month, after 18 months, after 24 months), and 36 months follow up
Other	Change in Personal and Social Performance Scale (PSP)	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.	Baseline, end of intervention (24 months) and 36 months follow up.
Other	Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS)	14 item questionnaire measuring mental wellbeing (non-index parent) scores range from 14 to 70, the higher scores, the better mental wellbeing	Baseline, end of intervention (24 months) and 36 months follow up.
Other	Change in Global Assessment of Function - Symptoms (GAF-S)	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.	Baseline, end of intervention (24 months) and 36 months follow up.
Other	Change in Kessler Psychological Distress Scale, K10	10 item questionnaire on psychological distress with a five-level response scale. Scale from 10-50. Higher score indicating higher level of psychological distress.	Baseline, end of intervention (24 months) and 36 months follow up.
Other	Change in General Self-Efficacy Scale (GSE)	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.	Baseline, end of intervention (24 months) and 36 months follow up.
Other	Change in Social Provision Scale-short form (SPS)	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	Baseline, end of intervention (24 months), and 36 months follow up
Other	Change in Quality-adjusted life year (EQ-5D)	6 item questionnaire, range from 0-100, the higher score the better health	Baseline, end of intervention (24 months) and 36 months follow up.
Other	Change in Self-Stigma of Mental Illness Scale - short form (SSMIS-SF)	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).	Baseline, end of intervention (24 months) and 36 months follow up.
Other	Change in The Questionnaire about the Process of Recovery (QPR)	15 item questionnaire on the process of recovery on a 4-point scale. Higher scores are indicative of recovery. Only index parent.	Baseline, end of intervention (24 months) and 36 months follow up.
Primary	Change in Strengths and Difficulties Questionnaire (SDQ)	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).	Baseline, end of intervention (24 months) and 36 months follow up.
Primary	Change in Bayley-4 Bayley Scales Test for Infant and Toddler Development	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	Baseline, after 6 months, after 12 months, after 18 months and after 24 months.
Primary	Change in Family Assessment Device - General Function Scale (FAD-GF)	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.	Baseline, end of intervention (24 months), and 36 months follow up
Primary	Change in Parental Stress Scale (PSS)	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.	Baseline, end of intervention (24 months) and 36 months follow up.
Secondary	Change in Home Observation for Measurement of the Environment (HOME)	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.	Baseline, end of intervention (24 months) and 36 months follow up.
Secondary	Change in Parenting and Family Adjustment Scales (PAFAS)	30 item questionnaire assessing changes in parenting practices, parental adjustment, and family relationships. Scores from 0-90, higher scores indicates poorer parenting or adaptation	Baseline, end of intervention (24 months), and 36 months follow up
Secondary	Change in Children's Global Assessment Scale (CGAS)	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.	Baseline, end of intervention (24 months) and 36 months follow up
Secondary	Change in Perceived Stress Scale (PSS)	10 item questionnaire measuring perceived stress (parents)	Baseline, end of intervention (24 months) and 36 months follow up.
Secondary	Client Satisfaction Scale (CSQ)	Questionnaire with 8 items measuring patient/client .Total scores range from 8 to 32, with the higher number indicating greater satisfaction.	End of intervention (24 months)