Internet-based Program for Prevention and Early Intervention of Adolescent Depression

Study Overview
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Brief Summary
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Background: Depression is prevalent and can have devastating effects on the life of adolescents. Computerized intervention programs for depression have shown positive results. There is less evidence in prevention and early treatment for depression in Latin American adolescents. Purpose: The purpose of this study is to determine whether a stepped internet-based program is effective to prevent and early intervene depression in adolescents attending 9th to 11th grade in eight schools in Santiago, Chile. Study design: A two-arm cluster-randomized clinical trial will be carried out with approximately 600 adolescents.

Official Title
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Efficacy of a Stepped Internet-based Program for Prevention and Early Intervention of Depression in Adolescents

Conditions
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Depressive Symptoms

Intervention / Treatment
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* Behavioral: Take care of your mood (CUIDA TU ANIMO in Spanish)
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Attending from ninth grade to eleventh grade in the eight participating schools. Informed consent and informed assent. Score in the depression questionnaire PHQ-9 adolescent version between 5 and 14. Exclusion Criteria: High suicide risk defined by score in question 9 of the PHQ-9 adolescent version of 2 or more. Current treatment with antidepressant drugs. Current treatment with psychotherapy.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The intervention consists of an Internet-based program. The program will last 3 months, with subsequent monthly reinforcement sessions for other 3 months. The program is stepped, so that the more depressive symptomatology the more intensive program and consists of more components. The students will interact with the program via a monitoring and feedback e-mail with 3 questions of the PHQ--9- adolescent version (1st, 2nd & 9th question) that they will receive every 2 weeks and a Website that will allow them to access to psycho-educational videos and information. There will also in the Website sections that will provide emergency information, the possibility of a contact via e-mail, and group chats. Adolescents with more depressive symptoms or suicidal risk will be invited to participate in an online counselling appointment or a face to face assessment with a mental health professional of the program. | Behavioral: Take care of your mood (CUIDA TU ANIMO in Spanish)<br>* The adolescents will be registered in the Website www.cuidatuanimo.org<br>|
| Other: Control group<br>The comparison group will receive general psychoeducation of depression in adolescents and will be on the waiting list to receive the intervention in the event that its efficacy is demonstrated. | Other: Control<br>* The adolescents will visit the Website www.cuidatuanimo.org, but they can not register<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Symptoms | Patient Health Questionnaire-9 (PHQ-9) adolescent version, total score varies between 0 and 27, higher values represent a worse outcome | 6 months after baseline assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Symptoms | Patient Health Questionnaire-9 (PHQ-9) adolescent version, total score varies between 0 and 27, higher values represent a worse outcome | 12 months after baseline assessment | 
| Anxiety Symptoms | Generalized Anxiety Disorder-7 (GAD-7) adolescent version, total score varies between 0 and 21, higher values represent a worse outcome | 6 and 12 months after baseline assessment | 
| Health-Related Quality of Life Index | KIDSCREEN-10 index, total score varies between -3.53 and 83.8, higher values represent a better outcome | 6 and 12 months after baseline assessment | 
| Social Problem Solving Skills | Social Problem Solving Inventory-Revised Short Form (SPSI-RS), positive problem subscale orientation, and rational problem solving subscale, total score of each subscale varies between 0 to 20, higher scores represent better outcome | 6 and 12 months after baseline assessment | 
| Dysfunctional Thoughts | Children's Automatic Thought Questionnaire (CATS), personal failure subscale, total score of the subscale varies between 0 and 40, higher values represent worse outcome | 6 and 12 months after baseline assessment | 
| Emotion Regulation | Emotion Regulation Questionnaire (ERQ), reappraisal subscale, total score of the subscale varies between 6 and 42, higher values represent better outcome | 6 and 12 months after baseline assessment | 
| Depression Stigma | Depression Stigma Scale (DSS), personal stigma subscale, total score of the subscale varies between 0 and 36, higher values represent worse outcome | 6 and 12 months after baseline assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, adolescence, prevention, early intervention, internet-based