- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07674017
Effectiveness of MBT-C Among Foster Children
Effectiveness of Mentalization-Based Treatment on Emotion Regulation and Emotional Awareness Among Children in Foster Care
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Isfahan, Iran
- Isfahan Welfare Organization
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- having emotional and behavioral difficulties, diagnosed using the cutoff score of 14 or higher on the carer-report version of the Strengths and Difficulties Questionnaire (SDQ), including scores of 5 or higher on the Emotional Symptoms subscale and 3 or higher on the Conduct Problems subscale.
- Aged 7 to 12 years.
- Living with foster parents for at least 4 weeks
Exclusion Criteria:
- Presence of an intellectual disability.
- A diagnosed psychiatric disorder documented in the records of the Child Welfare Organization.
- Participating in other psychotherapeutic interventions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: MBT-C
|
MBT-C is a transdiagnostic, time-limited, and manualized psychotherapy for children, delivered with parallel parent sessions. The model emphasizes a predetermined number of sessions, a treatment calendar, and a focused case formulation. A clear therapeutic contract is established at the beginning with both parents and children, fostering collaboration, agency, and transparency which is a significant aspect of the mentalizing stance. While MBTC is designed to address multiple domains, including explicit mentalization, attention control, and relational capacities, these domains were considered supportive targets in the present study, as they contribute to strengthening children's emotion regulation. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional awareness
Time Frame: Baseline: One day before the first intervention session. Post-test: One day after the final intervention session. Follow-up: Two months after the final intervention session.
|
Emotional awareness is defined as the conscious ability to recognize, differentiate, and verbalize one's own emotions, while also identifying and interpreting the emotions of others, thereby supporting adaptive coping and psychological wellbeing.
It was measured using the Emotion Awareness Questionnaire (EAQ).
It is a 30-item self-report measure of emotional awareness comprising six subscales: Differentiating Emotions, Verbal Sharing of Emotions, Bodily Awareness of Emotions, Acting Out Emotions, Analysis of Emotions, and Awareness of Others' Emotions.
Subscale scores may be examined separately, and a total score can be calculated to reflect overall emotional awareness.
Total scores range from 30 to 90, with higher scores indicating greater emotional awareness.
|
Baseline: One day before the first intervention session. Post-test: One day after the final intervention session. Follow-up: Two months after the final intervention session.
|
|
Emotion regulation
Time Frame: Baseline: One day before the first intervention session. Post-test: One day after the final intervention session. Follow-up: Two months after the final intervention session.
|
Emotion regulation refers to the internal and external processes through which individuals monitor, evaluate, and modify emotional experiences to achieve adaptive functioning.
It was measured using The Emotional Regulation Checklist (ERC).
This 24-item checklist is a caregiver-report measure designed to assess children's emotional expressiveness and regulation.
Respondents rate each item on a 4-point Likert scale, ranging from 1 (rarely/never) to 4 (almost always).
The ERC comprises two distinct subscales: Emotion Regulation (8 items; score range = 8-32) and Lability/Negativity (15 items; score range = 15-60).
Scores for each subscale can be interpreted independently, with higher scores on the Emotion Regulation subscale indicating stronger regulatory capacities and higher scores on the Lability/Negativity subscale reflecting greater emotional dysregulation.
|
Baseline: One day before the first intervention session. Post-test: One day after the final intervention session. Follow-up: Two months after the final intervention session.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IR.ARDAKAN.REC.1403.023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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