NCT07674017

Brief Summary

This study examined whether Mentalization-Based Treatment for Children (MBT-C) could improve emotion regulation and emotional awareness among children in foster care. Thirty children aged 7-12 years were randomly assigned to either an MBT-C intervention group or a control group. The intervention group participated in 12 treatment sessions, while the control group received no intervention. Results showed that children who received MBT-C demonstrated improvements in adaptive emotion regulation and emotional awareness, and these improvements were maintained two months later. The findings suggest that MBT-C may be a useful intervention for supporting the emotional development of children in foster care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 2, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 20, 2026

Last Update Submit

June 25, 2026

Conditions

Keywords

Foster childrenEmotion regulationEmotional awarenessMentalization

Outcome Measures

Primary Outcomes (2)

  • Emotional awareness

    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

    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.

Study Arms (2)

MBT-C

EXPERIMENTAL
Behavioral: Mentalization-based treatment for children

Control group

NO INTERVENTION

Interventions

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.

MBT-C

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Presence of an intellectual disability.
  • A diagnosed psychiatric disorder documented in the records of the Child Welfare Organization.
  • Participating in other psychotherapeutic interventions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan Welfare Organization

Isfahan, Iran

Location

MeSH Terms

Conditions

Emotional Regulation

Interventions

Mentalization-Based Therapy

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.A. in psychology

Study Record Dates

First Submitted

June 20, 2026

First Posted

June 29, 2026

Study Start

April 2, 2024

Primary Completion

October 22, 2024

Study Completion

October 22, 2024

Last Updated

June 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations