Foster CareNCT07674017
Effectiveness of MBT-C Among Foster Children
A study testing Mentalization-based treatment for children in people with Foster Care, run by Ardakan University at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Foster Care
- What is being tested?
- Mentalization-based treatment for children
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- 2 Apr 2024to 22 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Presence of an intellectual disability.
- A diagnosed psychiatric disorder documented in the records of the Child Welfare Organization.
- Participating in other psychotherapeutic interventions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Mentalization-Based Treatment on Emotion Regulation and Emotional Awareness Among Children in Foster Care
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.
- Conditions
- Foster Care
- Being tested
- Mentalization-based treatment for children
- Keywords
- Foster children, Emotion regulation, Emotional awareness, Mentalization
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentalization-based treatment for childrenBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MBT-C | Experimental | Not described Receives: Behavioral: Mentalization-based treatment for children |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start2 Apr 2024
- Primary completion22 Oct 2024
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foster CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asieh Hasanpour Souderjani, Ardakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674017
- Sponsor's protocol ID
- IR.ARDAKAN.REC.1403.023
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mentalization-Based Treatment on Emotion Regulation and Emotional Awareness Among Children in Foster Care
- ClinicalTrials.gov ID
- NCT07674017
- Acronym / sponsor ID
- IR.ARDAKAN.REC.1403.023
- Conditions
- Foster Care
- Keywords
- Foster children, Emotion regulation, Emotional awareness, Mentalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ardakan UniversityUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBT-C | Experimental | Behavioral: Mentalization-based treatment for children |
| Control group | No intervention | – |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Presence of an intellectual disability.
- A diagnosed psychiatric disorder documented in the records of the Child Welfare Organization.
- Participating in other psychotherapeutic interventions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentalization-based treatment for childrenMBT-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. | Behavioural | MBT-C |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentalization-based treatment for children in people with Foster Care, run by Ardakan University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.