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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06102564
Other study ID # ERCPN 264_29_02_2023
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 2023
Est. completion date July 2025

Study information

Verified date October 2023
Source Maastricht University
Contact Jeffrey Roelofs, PhD
Phone +31433881607
Email j.roelofs@maastrichtuniversity.nl
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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". 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date July 2025
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Eligible patients for the group schematherapy are mothers with young children (0-5 years), with a cluster C personality disorder. Exclusion Criteria: - 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) - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Group schematherapy
Brief group schematherapy for mothers with young children (age 0-5) focused on attachment relations between mother and child

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Psychologiepraktijk Esra

Outcome

Type Measure Description Time frame Safety issue
Other The Working Model of the child interview (WMCI; Zeanah, Benoit & Barton, 1996) The WMCI is a semistructured interview to asses the internal representations of their child and relationship with the child. Inclusion Week 1
Other The Childhood Trauma Questionnaire (CTQ; Bernstein, 1994) A self report measure to identify diffent types of childhood trauma and abuse. Inclusion Week 1
Primary 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) 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)
Primary The Parental Reflective Functioning Questionnaire (PRFQ, 2009) A self-report instrument of reflective functioning. 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 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 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 The Schema Mode Inventory (SMI, Lobbestael, 2017) To asses schema modes (118 items) 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 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. 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 The Beck Depression Inventory (BDI; Beck et al., 1996) A self-report questionnaire of depressive symptoms. 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)
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