Child Mental HealthWellComNCT06795347
Wellbeing and Resilience Among 1-3 Years Old Children of Mothers with Complex Mental Health Problems: a Pragmatic Clinical Trial of Online VIPP-SD Vs. Care As Usual
A study testing Online VIPP-SD and Care As Usual in people with Child Mental Health and Behavioral Symptoms, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Children of parents with severe mental disorders have an increased risk of mental disorders themselves, with more than half of this population diagnosed with a mental health condition during their life time. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Child Mental Health, Behavioral Symptoms, Child of Impaired Parents
- What is being tested?
- Online VIPP-SD and Care As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2025to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child age 1 year, 0 months until 3 years, 0 months
- living with their mother in the Region of Southern Denmark
- mother has a mental disorder (Schizophrenia ICD-10: F20-29, Bipolar disorder ICD-10: F30-31, Moderate to severe depression ICD-10: F32-33 or Emotionally unstable personality disorder F60.3) verified in the Danish National Hospital Register-Psyk/the Danish Psychiatric Central Research Register or by a clinician at the mental health services via the patient record
- mother has had at least one in- or outpatient contact with mental health services within 12 months before birth of the child or during the child's lifetime verified in the Danish National Hospital Register or by a clinician at the mental health services via the patient record
Who cannot join
- current in-patient status of the mother
- current substance or alcohol abuse of the mother
- mother has insufficient knowledge of Danish (interpreter required)
- repeated intrauterine exposure to euphoriants or large amounts of alcohol (≥5 units per time or ≥7units per week) of the child
- known syndrome or autism spectrum disorder of the child
- mother or child has sensory impairment
Show all 9Show fewer
- sibling participating in study
- family participating in another closely related research trial receiving an individualized video-feedback intervention
- participating in active court proceedings
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Research Unit of Child and Adolescent Psychiatry, Mental Health Services in the Region of Southern Denmark
Odense C, Region Syddanmark, 5000
Kirstine A Davidsen, PhD, +4599448681, kirstine.agnete.davidsen@rsyd.dk
About this study
Official title: Wellbeing and Resilience Among 1-3 Years Old Children of Mothers with Complex Mental Health Problems: a Pragmatic Clinical Trial
Children of parents with severe mental disorders have an increased risk of mental disorders themselves, with more than half of this population diagnosed with a mental health condition during their life time. Already during early childhood, the risk of a mental health diagnosis is elevated by a factor 2-5, compared to children of parents without severe mental disorders. This highlights the need for preventive interventions.
Mental health during early childhood is inextricably linked with early parent-child interaction. Sensitive parenting plays a crucial role in the socio-emotional development of the child, and severe parental mental disorders may affect the quality of parent-child interaction.
Read more
Therefore, we will test the effect of an intervention promoting sensitive parenting on mental health outcomes of 1-3 years old children of parents with severe mental disorders. The intervention will be tested in a randomized clinical trial comparing the intervention "Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline" (VIPP-SD) delivered online to Care As Usual. Our hypothesis is, that children in the Intervention Group will display lower levels of behavioral problems and increased attachment security compared to children in the Care As Usual Group.
The study will be conducted in the department of Child and Adolescent Psychiatry, Mental Health Services in the Region of Southern Denmark. Participants are mothers with a diagnosis of schizophrenia, bipolar disorder, emotionally unstable personality disorder or moderate to severe depression living in the Region of Southern Denmark with their 1-3 years old child, and the father/cohabitating partner. Participants will be recruited via psychiatric outpatient clinics in the region or on the basis of information from health registers.
The primary outcome of the study is child behavioral problems. Secondary child outcomes are attachment security and mental health. Parental outcomes are parental stress and quality of life. Child cognition, parental psychiatric symptoms, childhood trauma, sensitivity, parental reflective functioning and service use data are also assessed in the study. Data are collected at baseline as well as 5 and 11 months after randomization. All participants will have the opportunity to receive feedback on their child's cognitive functioning and mental health status at baseline and at the end of the study.
After baseline assessments, participants will be randomized to either intervention or the control group.
The intervention, VIPP-SD, is delivered online apart from the first session, which is conducted as a home visit. VIPP-SD is based on attachment and social learning theory. It is manualized and consists of 12 individual sessions alternating between video-recording of mother and child in pre-defined everyday situations and review/discussion of the video recordings with the mother/parents. Focus of the intervention is the childs signals and needs, and how to promote healthy socio-emotional development of the child. VIPP-SD will be carried out by health care professionals trained and certified in VIPP-SD.
Participants who are randomized to the control condition, Care As Usual, will continue as they did before enrollment to the study. Care As Usual is defined as any kind of help and support related to the social-emotional development and mental wellbeing of the child in the municipality or mental health services.
- Being tested
- Online VIPP-SD, Care As Usual
- Keywords
- Parental psychiatric disorder, Child mental disorders, Prevention, Socio-emotional development, Child behavioral problems, Child externalizing problems, Parental sensitivity
- Medical subject headings
- Behavioral Symptoms, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online VIPP-SDBehavioural
The Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline is delivered online in this study. VIPP-SD is a manualized parenting intervention. The online version consists of 12 individual sessions, where the first and hereafter every second session consists of video recordings of mother and child in pre-defined everyday situations. The recordings are reviewed and discussed with the mother/parents during subsequent video-feedback sessions, where positive sequences in the interaction are pointed out by the intervener and form the basis of a discussion of pre-defined themes regarding child signals, attachment, child development, limit setting and sensitive parenting. The 12 sessions are conducted within five months from randomization with weekly or bi-weekly intervals.
Care As UsualBehavioural
Care As Usual is defined as any kind of help and support the parents may receive related to the socio-emotional development and mental wellbeing of their child in the municipality or the mental health services.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (VIPP-SD) | Experimental | Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) delivered online Receives: Behavioral: Online VIPP-SD |
| Care As Usual | Other | Care As Usual is defined as any kind of help and support the parents may receive related to the socio-emotional development and mental wellbeing of their child in the municipality or the mental health services. Receives: Behavioral: Care As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preschool Parental Account of Children's symptoms (P-PACS)
The P-PACS is a semistructured researcher-led interview administered to the mother, assessing level of child behavioral problems. Change in level of child behavioral problems is the primary outcome of the study.
Measured: The P-PACS will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.
Secondary outcomes (9)
Child Behavior Check List/1 ½-5 (CBCL/1 ½-5)
The Danish version of the CBCL/1 ½-5 will be completed by both (cohabitating) parents. Change in Total problems score, and Internalizing and Externalizing subscale scores is used as a secondary outcome measure.
Measured: CBCL/1 ½-5 will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.
Caregiver-Teacher Report Form (C-TRF)
The Danish version of the C-TRF will be completed by the child's day care teacher. Change in Total problems score, and Internalizing and Externalizing subscale scores is used as a secondary outcome measure.
Measured: C-TRF will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.
Baby-DIPS
The Baby-DIPS is a structured interview designed for the diagnosis of former and current regulatory problems (excessive crying, feeding or sleeping disorder). It is conducted with the mother. Change in regulatory problems will be used as a secondary outcome.
Measured: Baby-DIPS will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.
the Brief Attachment Scale-16 (BAS-16)
BAS-16 is used for evaluating child attachment security in relation to both mother and (cohabitating) father. The BAS-16 is based on two scales, the "happy and harmonious interactions" and "proximity and physical-contact seeking". Change in mean score will be used as outcome.
Measured: The BAS-16 will be administered at baseline (T0) and 11 months (T2) after randomization.
Parental Stress Scale (PSS)
The questionnaire Parental Stress Scale will be completed by both (cohabitating) parents. A total score and two subscale scores (Parental Stress and Parental Satisfaction) will be calculated.
Change in mean scores will be used as outcome.
Measured: The Parental Stress Scale will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.
Parental Sensitivity
Parental sensitivity wil be assessed with the Coding of Interactive behavior on the basis of video-recordings of child in interaction with mother and father/cohabitating partner during a structured interaction containing a difficult task. The sensitivity socre is a composite score based on predefined parental subscales and ranges between one and five, with high scores indicating a high degree of sensitivity.
Measured: Sensitivity will be assessed at T0 and T1.
Parental Reflective Functioning Questionnaire (PRFQ)
The PRFQ is a questionnaire assessing self-reported parental reflective functioning. The items are divided into three categories: Prementalizing modes, Certainty about mental states and Interest and curiousity about mental states.
Measured: The PRFQ will be completed by both (cohabitating) parents at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.
EQ-5D-5L
Quality of life is assessed with the Danish version of the EQ-5D-5L, a self-report measure assessing the impact of health on an individual's everyday life. EQ-5D-5L is completed by both (cohabitating) parents. Change in mean score will be used as secondary outcome measure.
Measured: EQ-5D-5L will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.
Symptom Checklist-90-revised (SCL-90-R)
The SCL-90-R is a self-report questionnaire, which will be used to evaluate parental psychopathology. It is completed by both (cohabitating) parents.
Measured: The SCL-90-R is completed at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Mental HealthStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark
- Responsible party
- Principal investigator, Kirstine Agnete Davidsen, University of Southern Denmark
- Investigators
- Davi, Principal investigator, Region of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795347
- Sponsor's protocol ID
- S-20240007
- Other IDs
- 158789
- Acronym
- WellCom
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellbeing and Resilience Among 1-3 Years Old Children of Mothers with Complex Mental Health Problems: a Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT06795347
- Acronym / sponsor ID
- WellCom / S-20240007
- Keywords
- Parental psychiatric disorder, Child mental disorders, Prevention, Socio-emotional development, Child behavioral problems, Child externalizing problems, Parental sensitivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Region of Southern Denmark
- Study start
- Feb 2025 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children of parents with severe mental disorders have an increased risk of mental disorders themselves, with more than half of this population diagnosed with a mental health condition during their life time. Already during early childhood, the risk of a mental health diagnosis is elevated by a factor 2-5, compared to children of parents without severe mental disorders. This highlights the need for preventive interventions.
Mental health during early childhood is inextricably linked with early parent-child interaction. Sensitive parenting plays a crucial role in the socio-emotional development of the child, and severe parental mental disorders may affect the quality of parent-child interaction.
Therefore, we will test the effect of an intervention promoting sensitive parenting on mental health outcomes of 1-3 years old children of parents with severe mental disorders. The intervention will be tested in a randomized clinical trial comparing the intervention "Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline" (VIPP-SD) delivered online to Care As Usual. Our hypothesis is, that children in the Intervention Group will display lower levels of behavioral problems and increased attachment security compared to children in the Care As Usual Group.
The study will be conducted in the department of Child and Adolescent Psychiatry, Mental Health Services in the Region of Southern Denmark. Participants are mothers with a diagnosis of schizophrenia, bipolar disorder, emotionally unstable personality disorder or moderate to severe depression living in the Region of Southern Denmark with their 1-3 years old child, and the father/cohabitating partner. Participants will be recruited via psychiatric outpatient clinics in the region or on the basis of information from health registers.
The primary outcome of the study is child behavioral problems. Secondary child outcomes are attachment security and mental health. Parental outcomes are parental stress and quality of life. Child cognition, parental psychiatric symptoms, childhood trauma, sensitivity, parental reflective functioning and service use data are also assessed in the study. Data are collected at baseline as well as 5 and 11 months after randomization. All participants will have the opportunity to receive feedback on their child's cognitive functioning and mental health status at baseline and at the end of the study.
After baseline assessments, participants will be randomized to either intervention or the control group.
The intervention, VIPP-SD, is delivered online apart from the first session, which is conducted as a home visit. VIPP-SD is based on attachment and social learning theory. It is manualized and consists of 12 individual sessions alternating between video-recording of mother and child in pre-defined everyday situations and review/discussion of the video recordings with the mother/parents. Focus of the intervention is the childs signals and needs, and how to promote healthy socio-emotional development of the child. VIPP-SD will be carried out by health care professionals trained and certified in VIPP-SD.
Participants who are randomized to the control condition, Care As Usual, will continue as they did before enrollment to the study. Care As Usual is defined as any kind of help and support related to the social-emotional development and mental wellbeing of the child in the municipality or mental health services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (VIPP-SD) | Experimental | Behavioral: Online VIPP-SDVideo-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) delivered online |
| Care As Usual | Other | Behavioral: Care As UsualCare As Usual is defined as any kind of help and support the parents may receive related to the socio-emotional development and mental wellbeing of their child in the municipality or the mental health services. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- child age 1 year, 0 months until 3 years, 0 months
- living with their mother in the Region of Southern Denmark
- mother has a mental disorder (Schizophrenia ICD-10: F20-29, Bipolar disorder ICD-10: F30-31, Moderate to severe depression ICD-10: F32-33 or Emotionally unstable personality disorder F60.3) verified in the Danish National Hospital Register-Psyk/the Danish Psychiatric Central Research Register or by a clinician at the mental health services via the patient record
- mother has had at least one in- or outpatient contact with mental health services within 12 months before birth of the child or during the child's lifetime verified in the Danish National Hospital Register or by a clinician at the mental health services via the patient record
Key exclusion criteria (9 listed)
- current in-patient status of the mother
- current substance or alcohol abuse of the mother
- mother has insufficient knowledge of Danish (interpreter required)
- repeated intrauterine exposure to euphoriants or large amounts of alcohol (≥5 units per time or ≥7units per week) of the child
- known syndrome or autism spectrum disorder of the child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online VIPP-SDThe Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline is delivered online in this study. VIPP-SD is a manualized parenting intervention. The online version consists of 12 individual sessions, where the first and hereafter every second session consists of video recordings of mother and child in pre-defined everyday situations. The recordings are reviewed and discussed with the mother/parents during subsequent video-feedback sessions, where positive sequences in the interaction are pointed out by the intervener and form the basis of a discussion of pre-defined themes regarding child signals, attachment, child development, limit setting and sensitive parenting. The 12 sessions are conducted within five months from randomization with weekly or bi-weekly intervals. | Behavioural | Intervention (VIPP-SD) |
| Care As UsualCare As Usual is defined as any kind of help and support the parents may receive related to the socio-emotional development and mental wellbeing of their child in the municipality or the mental health services. | Behavioural | Care As Usual |
Primary outcome
Preschool Parental Account of Children's symptoms (P-PACS)
Time frame: The P-PACS will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.
The P-PACS is a semistructured researcher-led interview administered to the mother, assessing level of child behavioral problems. Change in level of child behavioral problems is the primary outcome of the study.
9 secondary outcomes
Child Behavior Check List/1 ½-5 (CBCL/1 ½-5)
Time frame: CBCL/1 ½-5 will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.
Caregiver-Teacher Report Form (C-TRF)
Time frame: C-TRF will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.
Baby-DIPS
Time frame: Baby-DIPS will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.
the Brief Attachment Scale-16 (BAS-16)
Time frame: The BAS-16 will be administered at baseline (T0) and 11 months (T2) after randomization.
Parental Stress Scale (PSS)
Time frame: The Parental Stress Scale will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.
Parental Sensitivity
Time frame: Sensitivity will be assessed at T0 and T1.
Parental Reflective Functioning Questionnaire (PRFQ)
Time frame: The PRFQ will be completed by both (cohabitating) parents at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.
EQ-5D-5L
Time frame: EQ-5D-5L will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.
Symptom Checklist-90-revised (SCL-90-R)
Time frame: The SCL-90-R is completed at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Davi principal investigator
Region of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online VIPP-SD and Care As Usual in people with Child Mental Health and Behavioral Symptoms, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirstine A Davidsen, PhD (+4599448681, kirstine.agnete.davidsen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preschool Parental Account of Children's symptoms (P-PACS) (time frame: The P-PACS will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.