Cluster C Personality Disorder (Diagnosis)NCT06102564
GST-moms: Effects of Group-schematherapy on Mother-child Attachment Relations
An observational study of Cluster C Personality Disorder (Diagnosis) and Mother-Child Relations, run by Maastricht University.
Trial summary
The birth of a baby can be a stressful period. Dysfunctional schemas of the 'new' parent can be triggered making it more difficult to discern what the baby needs are. In schema therapy terms, mentalizing capacity is best described as the "healthy adult mode". Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cluster C Personality Disorder (Diagnosis), Mother-Child Relations
- What is being tested?
- Group schematherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Jul 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Mothers with young children (0-5 years) with Cluster C personality disorder or mixed/other personality disorder (cluster C and cluster B traits) who encounter problems in the mother-child interaction. They may have depressive and/or anxiety symptoms aswell.
Who may be able to join
- Eligible patients for the group schematherapy are mothers with young children (0-5 years), with a cluster C personality disorder.
Who cannot join
- Acute Suicidal or chronic suicidality
- Psychotic disorder
- Autistic spectrum disorder
- Bipolar disorder
- Developmental disorders
- Any other AS-I disorder that requires treatment first (severe depression, alcohol and/or drugs abuse)
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- Cluster A or B personality disorders (traits of cluster B in combination with Cluster C personality disorder is included)
- Neuropsychological damage
- General problems for group therapy (auditory impairment, severe physical disability, insufficant Dutch comprehension, IQ < 80)
- Self-mutilation
Trial locations and contacts
No sites are listed yet.
Esra Schuiling-Kayihan, MSc contact
About this study
Official title: GST-moms: Effects of Group-schematherapy on Mother-child Attachment
The birth of a baby can be a stressful period. Dysfunctional schemas of the 'new' parent can be triggered making it more difficult to discern what the baby needs are. In schema therapy terms, mentalizing capacity is best described as the "healthy adult mode". A parent who responds to her baby from a healthy adult mode provides the baby a safe environment for self-development. However, interpreting the baby's signals can be a constant challenge for some parents. This can trigger early attachment relationships and schemas. At such times, the parent may become overwhelmed by their own emotions and respond less adequate to the child's needs. Distorted parental reflective functioning is associated both with insecure attachment and poor affect regulation in the parent and with various psychological disorders in the child. Treatments aimed at improving parental reflectiveness seem to have a positive impact on the quality of the attachment between parents and their baby.
The objective of this study is to measure the effects of the group-schematherapy for mothers with young children (GST moms) on mother-child attachment relations. The aim is to help moms regulate their own emotions, by understanding their own modes and schema's. In doing so will help them feel more confident to mentalize about their child and to adequately respond to their needs and emotionally bond with their baby. The researchers anticipate it will improve the quality of attachment between mother and child. Many studies have been done on the effectiveness of group schematherapy however there are no studies specifically for schematherapy for parents, in this case mothers. GST moms can be an early intervention aimed at prevention of psychological problems with the child.
- Being tested
- Group schematherapy
- Keywords
- Group Schematherapy, Mother-child attachment, Effectiviness
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group schematherapyBehavioural
Brief group schematherapy for mothers with young children (age 0-5) focused on attachment relations between mother and child
What is being measured
The primary outcome is the main question the study is designed to answer.
The Maternal Postnatal attachment Scale (MPAS, 2015)
A 19 item self-report questionnaire that is used to assess mother-to-infant attachment (theemotional bond or affection experienced by the parent towards the infant)
Measured: Inclusion (week 1), start therapy (variable; at least 20 weeks after inclusion), evaluation (week 10), end of group therapy (week 20), follow-up (3 months completion = week 20)
The Parental Reflective Functioning Questionnaire (PRFQ, 2009)
A self-report instrument of reflective functioning.
Measured: Inclusion (week 1), start therapy (variable; at least 20 weeks after inclusion), evaluation (week 10), end of group therapy (week 20), follow-up (3 months completion = week 20)
Secondary outcomes (4)
The Young Schema Questionnaire YSQ-S3 (YSQ-S3; Young, 1994).
De Young Schema Questionnaire is a self-report instrument to assess 18 dysfunctional schemas and consists of 90 items
Measured: Inclusion (week 1), start therapy (variable; at least 20 weeks after inclusion), evaluation (week 10), end of group therapy (week 20), follow-up (3 months completion = week 20)
The Schema Mode Inventory (SMI, Lobbestael, 2017)
To asses schema modes (118 items)
Measured: Inclusion (week 1), start therapy (variable; at least 20 weeks after inclusion), evaluation (week 10), end of group therapy (week 20), follow-up (3 months completion = week 20)
Brief Sympthom Inventory (BSI, Derogatis, 1975, de Beurs, 2006)
A self-report questionnaire to evaluate a broad range of psychological problems and symptoms of psychopathology.
Measured: Inclusion (week 1), start therapy (variable; at least 20 weeks after inclusion), evaluation (week 10), end of group therapy (week 20), follow-up (3 months completion = week 20)
The Beck Depression Inventory (BDI; Beck et al., 1996)
A self-report questionnaire of depressive symptoms.
Measured: Inclusion (week 1), start therapy (variable; at least 20 weeks after inclusion), evaluation (week 10), end of group therapy (week 20), follow-up (3 months completion = week 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster C Personality Disorder (Diagnosis)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Psychologiepraktijk Esra
- Responsible party
- Principal investigator, Jeffrey Roelofs, Maastricht University
- Investigators
- Jeffrey Roelofs, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102564
- Sponsor's protocol ID
- ERCPN 264_29_02_2023
- Status last verified
- Oct 2023
- First submitted
- 13 Apr 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GST-moms: Effects of Group-schematherapy on Mother-child Attachment
- ClinicalTrials.gov ID
- NCT06102564
- Acronym / sponsor ID
- ERCPN 264_29_02_2023
- Keywords
- Group Schematherapy, Mother-child attachment, Effectiviness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Psychologiepraktijk Esra
- Study start
- Nov 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 26 Oct 2023 (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.
The birth of a baby can be a stressful period. Dysfunctional schemas of the 'new' parent can be triggered making it more difficult to discern what the baby needs are. In schema therapy terms, mentalizing capacity is best described as the "healthy adult mode". A parent who responds to her baby from a healthy adult mode provides the baby a safe environment for self-development. However, interpreting the baby's signals can be a constant challenge for some parents. This can trigger early attachment relationships and schemas. At such times, the parent may become overwhelmed by their own emotions and respond less adequate to the child's needs. Distorted parental reflective functioning is associated both with insecure attachment and poor affect regulation in the parent and with various psychological disorders in the child. Treatments aimed at improving parental reflectiveness seem to have a positive impact on the quality of the attachment between parents and their baby.
The objective of this study is to measure the effects of the group-schematherapy for mothers with young children (GST moms) on mother-child attachment relations. The aim is to help moms regulate their own emotions, by understanding their own modes and schema's. In doing so will help them feel more confident to mentalize about their child and to adequately respond to their needs and emotionally bond with their baby. The researchers anticipate it will improve the quality of attachment between mother and child. Many studies have been done on the effectiveness of group schematherapy however there are no studies specifically for schematherapy for parents, in this case mothers. GST moms can be an early intervention aimed at prevention of psychological problems with the child.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mothers with young children (0-5 years) with Cluster C personality disorder or mixed/other personality disorder (cluster C and cluster B traits) who encounter problems in the mother-child interaction. They may have depressive and/or anxiety symptoms aswell.
Key inclusion criteria (1 listed)
- Eligible patients for the group schematherapy are mothers with young children (0-5 years), with a cluster C personality disorder.
Key exclusion criteria (10 listed)
- Acute Suicidal or chronic suicidality
- Psychotic disorder
- Autistic spectrum disorder
- Bipolar disorder
- Developmental disorders
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 |
|---|---|---|
| Group schematherapyBrief group schematherapy for mothers with young children (age 0-5) focused on attachment relations between mother and child | Behavioural | – |
Primary outcome
The Maternal Postnatal attachment Scale (MPAS, 2015)
Time frame: Inclusion (week 1), start therapy (variable; at least 20 weeks after inclusion), evaluation (week 10), end of group therapy (week 20), follow-up (3 months completion = week 20)
A 19 item self-report questionnaire that is used to assess mother-to-infant attachment (theemotional bond or affection experienced by the parent towards the infant)
The Parental Reflective Functioning Questionnaire (PRFQ, 2009)
Time frame: Inclusion (week 1), start therapy (variable; at least 20 weeks after inclusion), evaluation (week 10), end of group therapy (week 20), follow-up (3 months completion = week 20)
A self-report instrument of reflective functioning.
4 secondary outcomes
The Young Schema Questionnaire YSQ-S3 (YSQ-S3; Young, 1994).
Time frame: Inclusion (week 1), start therapy (variable; at least 20 weeks after inclusion), evaluation (week 10), end of group therapy (week 20), follow-up (3 months completion = week 20)
The Schema Mode Inventory (SMI, Lobbestael, 2017)
Time frame: Inclusion (week 1), start therapy (variable; at least 20 weeks after inclusion), evaluation (week 10), end of group therapy (week 20), follow-up (3 months completion = week 20)
Brief Sympthom Inventory (BSI, Derogatis, 1975, de Beurs, 2006)
Time frame: Inclusion (week 1), start therapy (variable; at least 20 weeks after inclusion), evaluation (week 10), end of group therapy (week 20), follow-up (3 months completion = week 20)
The Beck Depression Inventory (BDI; Beck et al., 1996)
Time frame: Inclusion (week 1), start therapy (variable; at least 20 weeks after inclusion), evaluation (week 10), end of group therapy (week 20), follow-up (3 months completion = week 20)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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. This study is not recruiting at the moment.
Esra Schuiling-Kayihan, MSc contact
Jeffrey Roelofs, PhD principal investigator
Maastricht University
Questions about this trial
What is this clinical trial studying?
An observational study of Cluster C Personality Disorder (Diagnosis) and Mother-Child Relations, run by Maastricht University.
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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Roelofs, PhD (+31433881607, j.roelofs@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Maternal Postnatal attachment Scale (MPAS, 2015) (time frame: Inclusion (week 1), start therapy (variable; at least 20 weeks after inclusion), evaluation (week 10), end of group therapy (week 20), follow-up (3 months completion = week 20)). The study lists 2 primary outcomes in all. 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 26 Oct 2023.