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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02935218
Other study ID # RenRos01
Secondary ID
Status Completed
Phase N/A
First received August 30, 2016
Last updated October 13, 2016
Start date January 2015
Est. completion date October 2015

Study information

Verified date September 2016
Source Freie Universität Berlin
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

N=15 mothers with Borderline Personality Disorder who had young children (aged 0-6 years) participated in a 12-week training program. To estimate the participants' impairment, parental stress and psychological distress were assessed before the training. After the training, participants and trainers were asked to provide feedback regarding the valuation of and the changes due to the training.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date October 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Borderline diagnosis in mothers

- Infants between 6 months and 6 years

- Mothers and their children must be in regular contact with each other

Exclusion Criteria:

- Acute child endangerment

- Maternal acute suicidality

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Behavioral:
Parenting Skills for Mothers with BPD
The cognitive-behavioral Group Training for mothers with BPD consists of 12 weekly sessions promoting parenting skills including primary needs of children, stress and stress management, dealing with conflicts, mindfulness, emotion regulation, routine and flexibility, the role of the body in parenting, basic assumptions about parenting, and self-care.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Freie Universität Berlin

Outcome

Type Measure Description Time frame Safety issue
Primary written feedback the participants provide written feedback regarding the changes due to the parental skills training 12 weeks No
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