NCT06102564

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

April 13, 2023

Last Update Submit

October 21, 2023

Conditions

Keywords

Group SchematherapyMother-child attachmentEffectiviness

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (4)

  • The Young Schema Questionnaire YSQ-S3 (YSQ-S3; Young, 1994).

    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)

    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)

    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)

    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)

Other Outcomes (2)

  • The Working Model of the child interview (WMCI; Zeanah, Benoit & Barton, 1996)

    Inclusion Week 1

  • The Childhood Trauma Questionnaire (CTQ; Bernstein, 1994)

    Inclusion Week 1

Interventions

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

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Eligible patients for the group schematherapy are mothers with young children (0-5 years), with a cluster C personality disorder.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeffrey Roelofs, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Esra Schuiling-Kayihan, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator/Clinical professor (PhD)

Study Record Dates

First Submitted

April 13, 2023

First Posted

October 26, 2023

Study Start

November 1, 2023

Primary Completion

December 1, 2024

Study Completion

July 1, 2025

Last Updated

October 26, 2023

Record last verified: 2023-10