An interventional study of Short term mentalization-based treatment for adolescents (MBT-A) in Depression, sponsored by Universidad de Valparaiso. Recruiting at 1 site in Chile. Open to participants aged 10 Years to 14 Years. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Universidad de Valparaiso · Not applicable, Interventional, and Treatment
A feasibility pilot trial that aims to evaluate the acceptability and feasibility of mentalization-based treatment for adolescents (MBT-A) adapted for early adolescents diagnosed with depression.
Background. Adolescent depression is a highly prevalent public health concern, entailing substantial developmental impairments, a risk of chronicity, and severe outcomes, including suicide. Recent years have seen an escalation in depressive symptoms among adolescents, exacerbated by the COVID-19 pandemic. Currently, Chile lacks specific evidence-based clinical guidelines for family interventions in adolescent depression. Nonetheless, the executive summary of the Clinical Practice Guidelines for the Management of Adolescent Depression recognizes the need for such interventions. The 2022-2025 agenda for children and adolescents incorporates these interventions as part of the recommendations, addressing challenges identified by the System of Guarantees for the Comprehensive Protection of the Rights of Children and Adolescents and aligning with the International Convention on the Rights of Children and Adolescents' standards. The strategy proposed herein-a brief, mentalization-based treatment intervention for adolescents-aligns with two pivotal considerations for adolescent mental health care: accommodating the neurodevelopmental changes and vulnerabilities of this demographic, and leveraging the preventative potential of family interventions at a systemic level.
Aims. The study is a feasibility pilot trial that aims to evaluate the acceptability and feasibility of a short term mentalization based treatment for adolescents (MBT-A). 15 families of adolescents with a diagnosis of mild and moderate unipolar depression between 10 and 14 years old who consult at a primary health care center in Valparaíso will be recruited.
Methods. The design is based on the principles of the Consolidated Standards of Reporting Trials - Extension to Randomized Pilot and Feasibility Trials (CONSORT). Acceptability and feasibility outcomes will be assessed by means of questionnaires and interviews with both consultants and interveners, considering the training, clinical supervision, and intervention processes. Feasibility (recruitment, data attrition, and follow-up rates) and acceptability (adherence rate and CEQ) of the intervention, along with depressive (PHQ-9/RCADS-30), anxious (DASS-21), externalizing/internalizing (SDQ-SF) symptomatology, and Family Cohesion (FACES III) as secondary outcomes, will be considered. Therapeutic alliance (VTAS-SF), adherence to the therapeutic model (MBT-ACS), quality of patients' mentalization (OMP-A), and psychological well-being (CORE-OM/YP-CORE) will be assessed as well. The results of the analysis of interviews, as well as the calculation of the effect size of the intervention for the various outcomes, are considered as parameters and guidelines for a future RCT.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 15 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Universidad de Valparaiso is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short term Mentalization-based treatment for adolescents (psychotherapy).
Other: Short term mentalization-based treatment for adolescents (MBT-A)
The general framework of intervention corresponds to the Mentalization-Based Treatment model for adolescents (MBT-A). In this study, the model was adapted to a brief, time-limited format (12 sessions) aimed at both the adolescent and their family. The model retains the main characteristics of Mentalization-Based Therapy, such as the therapist's basic attitude toward actively promoting patients' mentalization, uncertainty of mental states, focus on the here and now, and the use of affect as a mechanism for change.
Recruitment rate
Number of subjects who agree to participate in the study compared to the number of subjects who are invited.
Time frame: After 3 months (at the end of therapy)
Data attrition rate
Number of subjects who complete the study with respect to subjects who are originally enrolled.
Time frame: After 3 months (at the end of therapy)
Follow-up rate
Number of subjects completing treatment and completing follow-up evaluations
Time frame: After 6 months (3 months after the end of therapy)
Adherence rate
Percentage of subjects completing all protocol assessments (including attendance at all 12 sessions).
Time frame: After 3 months (at the end of therapy)
Overall satisfaction with the intervention
Credibility/Expectancy Questionnaire (CEQ). Values range between 0 and 10 points. Each of the 8 items are analyzed separately. Higher scores indicate a better outcome, with the exception of item 6, which is reversed.
Time frame: Change from baseline in CEQ at 3 months (at the end of therapy)
Depressive symptomatology (adolescents)
Depression subscale of the Revised Child Anxiety and Depression Scale-30 (RCADS-30) for adolescents. Values range between 0 and 15 points. Lower scores indicate a better outcome.
Time frame: Change from baseline in the RCADS-30 depression subscale scores at 3 months (end of therapy) and at 5 months (follow-up)]
Depressive symptomatology (responsible adult)
Patient Health Questionnaire-9 (PHQ-9). Values range between 0 and 27 points. Lower scores indicate a better outcome.
Time frame: Change from baseline in PHQ-9 scores at 3 months (end of therapy) and 5 months (follow up).
Anxious symptomatology (adolescent)
Generalized anxiety subscale of the Revised Child Anxiety and Depression Scale-30 (RCADS-30) for adolescents. Values range between 0 and 15 points. Lower scores indicate a better outcome.
Time frame: Change from baseline in Generalized anxiety subscale of the Revised Child Anxiety and Depression Scale-30 (RCADS-30) for adolescents scores at 3 months (end of therapy) and 5 months (follow up).
Anxious symptomatology (responsible adult)
Anxiety subscale of the Depression, Anxiety and Stress Scale-21 (DASS-21). Values range between 0 and 21 points. Lower scores indicate a better outcome.
Time frame: Change from baseline in Anxiety subscale of the Depression, Anxiety and Stress Scale-21 (DASS-21) scores at 3 months (end of therapy) and 5 months (follow up).
Externalizing and internalizing symptomatology (adolescent)
Strengths and Difficulties Questionnaire - Short Form (SDQ-SF). Values range between 0 and 40 points. Lower scores indicate a better outcome.
Time frame: Change from baseline in the SDQ-SF scores at 3 months (end of therapy) and at 5 months (follow-up)
Family cohesion
Family Cohesion (FACES III). Values range between 0 and 50 points. Values between 41 to 45 (cohesion) and 25 to 28 (adaptability) indicate a better outcome.
Time frame: Change from baseline in the FACES III scores at 3 months (end of therapy) and at 5 months (follow-up)
Therapeutic alliance
Vanderbilt Therapeutic Alliance Scale - Short Form (VTAS-SF). Values range between 0 and 5 points. Each of the 5 items are analyzed separately. Higher scores indicate a better outcome, with the exception of item 3, which is reversed.
Time frame: Change in VTAS-SF scores through study completion, an average of 3 months
Adherence to the therapeutic model
Mentalization based treatment adherence and competence scale (MBT-ACS). Values range between 0 and 7 points. Higher scores indicate a better outcome.
Time frame: Change in MBT-ACS scores through study completion, an average of 3 months
Quality of patients' mentalization
Observational System for mentalization adolescent psychotherapy (OMP-A). Values range between 0 and 5 points. Higher scores indicate a better outcome.
Time frame: Change in OMP-A scores through study completion, an average of 3 months
Psychological well-being (responsible adult)
Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM). Values range between 0 and 136 points. Lower scores indicate a better outcome.
Time frame: Change in CORE-OM through study completion, an average of 3 months
Psychological well-being (adolescent)
Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE). Values range between 0 and 40 points. Lower scores indicate a better outcome.
Time frame: Change in YP-CORE through study completion, an average of 3 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Dec 2024, 15 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 15 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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