Brief Internet-delivered Intervention for Children and Adolescents With Anxiety and Depression Symptoms
Condition: Childhood Anxiety Disorder; Childhood Depression
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      Investigators developed a brief standardized internet-delivered cognitive-behavioral program
      for treating anxious and depressive symptoms in children and adolescents in the context of
      COVID-19 pandemics in Brazil. A 2-arm parallel-randomized controlled clinical trial will be
      conducted to test the efficacy of this program (intervention group), in comparison with a
      educational-only intervention program based on videos (active control group). 280 children
      and adolescents (8 to 17 years-old) with clinically significant anxious and/or depressive
      symptoms will be recruited through internet and social media. They will be randomized either
      to the intervention (n=140) or active control group (n=140). Participants will be recruited
      from across the country. The therapeutic program consists of 5 weekly sessions covering the
      following contents: education on stress reactions, family communication, relaxation and
      mindful techniques, emotion recognition, management of irritability, behavioral activation,
      and cognitive restructuring. The educational program consists of 15 videos covering the same
      content. Participants in the intervention group will also have access to these videos. Both
      child/adolescent and at least one caregiver will be required to take part in the sessions
      (and watch the videos). Participants will be assessed at the beginning (baseline; T0) at the
      end (endpoint; T1), and 30 days after the intervention (follow-up; T2) with standardized
      questionnaires, through an interview with a blinded investigator. Participants that develop
      severe symptomatology requiring further support during the intervention (such as psychiatric
      pharmacological treatment and/or more intensive psychotherapy) will be referred to adequate
      treatment. During the week prior to the intervention and the first week after its end,
      adolescents (older than 12 years-old) in both groups with access to a smartphone will be
      asked to report their momentary mood, emotions, and stress several times a day using the same
      smartphone app that will deliver the educational content to both groups. Adolescents will
      also be asked to install a second smartphone application that captures data from the phone
      sensors to provide proxies on behaviors associated with depression, such as social isolation
      (by the proximity with other devices, time spent on social media, as well as environmental
      sound and light) amount of inactivity (by assessing the maximum distance traveled throughout
      the day), among others.
    

Detailed description: 
      Investigators developed a brief standardized and manualized internet-delivered
      cognitive-behavioral (iCBT) program for treating anxious and depressive symptoms in children
      and adolescents in the context of COVID-19 pandemics in Brazil, to be implemented by trained
      psychologists. A 2-arm parallel-randomized controlled clinical trial (RCT) will be conducted
      to test the efficacy of this program (intervention group), in comparison with a
      educational-only intervention program based on videos (active control group). 280 children
      and adolescents (8 to 17 years-old) with clinically significant anxious and/or depressive
      symptoms (total t-score of 70 or above in the parent and child report versions of the 25-item
      Revised Children's Anxiety and Depression Scale) will be recruited through internet and
      social media. They will be randomized either to the intervention (n=140) or active control
      group (n=140). Since all interventions will be conducted online, participants will be
      recruited from across the country. The therapeutic program consists of 5 weekly sessions
      delivered to children or adolescents and their parents and covering the following contents:
      education on stress reactions, family communication, relaxation and mindful techniques,
      emotion recognition, management of irritability, behavioral activation, and cognitive
      restructuring. All sessions will be recorded and 10% of them will be randomly selected to be
      watched by one of the authors of the psychotherapeutic program to assess protocol adherence.
      The educational program consists of 15 videos covering the same content. Participants in the
      intervention group will also have access to these videos. Both child/adolescent and at least
      one caregiver will be required to take part in the sessions (and watch the videos).
      Participants in both groups will be assessed at the beginning (baseline; T0) at the end
      (endpoint; T1), and 30 days after the intervention (follow-up; T2) with standardized
      questionnaires, through an interview with a blinded investigator at T0, T1, and T2.
      Participants that develop severe symptomatology requiring further support during the
      intervention (such as psychiatric pharmacological treatment and/or more intensive
      psychotherapy) will be referred to adequate treatment. During the week prior to the
      intervention and the first week after its end, adolescents (older than 12 years-old) in both
      groups who have access to a smartphone will be asked to report their momentary mood,
      emotions, and stress several times a day using the same smartphone app that will deliver the
      educational content to both groups. Adolescents will also be asked to install a second
      smartphone application that captures data from the phone sensors to provide proxies on
      behaviors associated with depression, such as social isolation (by the proximity with other
      devices, time spent on social media, as well as environmental sound and light) amount of
      inactivity (by assessing the maximum distance traveled throughout the day), among others.
    

Intervention name(s): Telepsychotherapy; Psychoeducational Videos
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 5 weekly psychotherapy sessions that will cover the following contents: psychoeducation on stress responses, family communication, relaxation and mindful techniques, emotion recognition, management of irritability, behavioral activation and cognitive restructuring. The sessions will be implemented via the internet by a trained psychologist. Participants will also have access to the psychoeducational videos described at "intervention 2"; 15 educational videos to be watched by the families. There will be one video about psychoeducation on stress responses, one about family communication, four about mindfulness and relaxation techniques, two about emotion recognition, one about management of irritability, one about behavioral activation, three about healthy routines, one about cognitive restructuring, and one about management of anxiety crisis.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to be either in the intervention group (internet-based therapy) or the active control group (educational videos)
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Children; Anxiety; Depression; Stress; Cognitive Behavioral Therapy; Telemedicine; Irritability; Covid-19 pandemic; Adolescents