Feasibility and Acceptability of Mentalization-based Treatment for Early Adolescents With Depression: A Short Term Psychotherapy Approach for Patients and Their Families
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Diagnoses of autism spectrum disorders
- •Psychosis
- •Bipolar affective disorder
- •Active suicidal ideation
- •Substance use disorder.
- •Pregnancy
结局指标
主要结局
Recruitment rate
时间窗: After 3 months (at the end of therapy)
Number of subjects who agree to participate in the study compared to the number of subjects who are invited.
Overall satisfaction with the intervention
时间窗: Change from baseline in CEQ at 3 months (at the end of therapy)
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.
Data attrition rate
时间窗: After 3 months (at the end of therapy)
Number of subjects who complete the study with respect to subjects who are originally enrolled.
Follow-up rate
时间窗: After 6 months (3 months after the end of therapy)
Number of subjects completing treatment and completing follow-up evaluations
Adherence rate
时间窗: After 3 months (at the end of therapy)
Percentage of subjects completing all protocol assessments (including attendance at all 12 sessions).
次要结局
- Depressive symptomatology (adolescents)(Change from baseline in the RCADS-30 depression subscale scores at 3 months (end of therapy) and at 5 months (follow-up)])
- Anxious symptomatology (adolescent)(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).)
- Depressive symptomatology (responsible adult)(Change from baseline in PHQ-9 scores at 3 months (end of therapy) and 5 months (follow up).)
- Family cohesion(Change from baseline in the FACES III scores at 3 months (end of therapy) and at 5 months (follow-up))
- Anxious symptomatology (responsible adult)(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)(Change from baseline in the SDQ-SF scores at 3 months (end of therapy) and at 5 months (follow-up))
研究者
Javier Morán Kneer
Principal Investigator
Universidad de Valparaiso