Clinical trial NCT06252090: Feasibility and Acceptability Trial of a Short Term Mentalization Based Treatment for Adolescents With Depression
Official title: Feasibility and Acceptability of Mentalization-based Treatment for Early Adolescents With Depression: A Short Term Psychotherapy Approach for Patients and Their Families
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: Depression
Adolescent
Mentalization
Family
Psychotherapy
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
Collaborators: name: University Diego Portales
First posted: 2024-02-09
Enrollment: 15
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate major depressive disorder (DSM-5-TR and psychiatric interview).
* Written informed consent.
* Presence of at least one legally responsible adult consenting to participate in the therapeutic process.

Exclusion Criteria:

* Diagnoses of autism spectrum disorders
* Psychosis
* Bipolar affective disorder
* Active suicidal ideation
* Substance use disorder.
* Pregnancy

Primary outcomes:
measure: Recruitment rate
timeFrame: After 3 months (at the end of therapy)
measure: Data attrition rate
timeFrame: After 3 months (at the end of therapy)
measure: Follow-up rate
timeFrame: After 6 months (3 months after the end of therapy)
measure: Adherence rate
timeFrame: After 3 months (at the end of therapy)
measure: Overall satisfaction with the intervention
timeFrame: Change from baseline in CEQ at 3 months (at the end of therapy)
Secondary outcomes:
measure: Depressive symptomatology (adolescents)
timeFrame: Change from baseline in the RCADS-30 depression subscale scores at 3 months (end of therapy) and at 5 months (follow-up)]
measure: Depressive symptomatology (responsible adult)
timeFrame: Change from baseline in PHQ-9 scores at 3 months (end of therapy) and 5 months (follow up).
measure: Anxious symptomatology (adolescent)
timeFrame: 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).
measure: Anxious symptomatology (responsible adult)
timeFrame: 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).
measure: Externalizing and internalizing symptomatology (adolescent)
timeFrame: Change from baseline in the SDQ-SF scores at 3 months (end of therapy) and at 5 months (follow-up)
measure: Family cohesion
timeFrame: Change from baseline in the FACES III scores at 3 months (end of therapy) and at 5 months (follow-up)
Other outcomes:
measure: Therapeutic alliance
timeFrame: Change in VTAS-SF scores through study completion, an average of 3 months
measure: Adherence to the therapeutic model
timeFrame: Change in MBT-ACS scores through study completion, an average of 3 months
measure: Quality of patients' mentalization
timeFrame: Change in OMP-A scores through study completion, an average of 3 months
measure: Psychological well-being (responsible adult)
timeFrame: Change in CORE-OM through study completion, an average of 3 months
measure: Psychological well-being (adolescent)
timeFrame: Change in YP-CORE through study completion, an average of 3 months
Locations:
city: Valparaíso
country: Chile
facility: Jean & Marrie Thierry family public health center
Study officials:
References: