Clinical trial NCT05139433: Brief Internet-delivered Intervention for Children and Adolescents With Anxiety and Depression Symptoms
Official title: Brief Internet-delivered Cognitive-behavioral Intervention for Children and Adolescents With Anxiety and Depression Symptoms During the COVID-19 Pandemic: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Anxiety Disorder
Childhood Depression
Keywords: Children
Anxiety
Depression
Stress
Cognitive Behavioral Therapy
Telemedicine
Irritability
Covid-19 pandemic
Adolescents
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2021-12-01
Enrollment: 280
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to be either in the intervention group (internet-based therapy) or the active control group (educational videos)
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Children and adolescents aged between 8-17 years;
* Living in Brazil
* Total t-score of 70 or above in the 25-item version of the Revised Children's Anxiety and Depression Scale - parent report and child report versions

Exclusion Criteria:

* No contact between child/adolescent and parents in the 15 days previous to the beginning of the intervention
* Unavailability of at least one parent/caregiver to participate in all of the telepsychotherapeutic sessions (intervention group) or watch the videos along their child (active control group)
* Inability of the caregivers to understand the parent-report scales or the content of the interventions, according to the clinical judgement of a clinical psychologist
* Indications that the child might have a severe mental disorder and/or social condition that require a more intensive assessment and treatment, such as autism spectrum disorder, severe mood disorder, suicide risk, schizophrenia, intellectual disability, intense intrafamiliar conflict or intense maltreatment victimization, according to the clinical judgement of a clinical psychologist; suicidality will be assessed with the aid of the 4 questions of the Mood and Feelings Questionnaire (MFQ) questionnaire that focus on this trait ("S/he thought that life wasn't worth living", "S/he thought about death or dying", "S/he thought his/her family would be better off without him/her", "S/he thought about killing him/herself") (individuals that answer "yes" to the last question will be excluded from the study and referred to adequate and more intensive care)
* Current use or in the last 1 month of any psychiatric medication or psychotherapy

Primary outcomes:
measure: Anxiety and depressive symptoms at T1- caregiver report
timeFrame: At entry (T0), 1-3 days after the last psychotherapeutic session (intervention group) OR 1-3 days after the last video is made available (active control group)
measure: Anxiety and depressive symptoms at T1 - child/adolescent report
timeFrame: At entry (T0), 1-3 days after the last psychotherapeutic session (intervention group) OR 1-3 days after the last video is made available (active control group)
Secondary outcomes:
measure: anxiety and depressive symptoms at T2 - parent report
timeFrame: At entry (T0) and 30 days after the last psychotherapeutic session (intervention group) or 30 days after the last video is made available (active control group) (T2)
measure: anxiety and depressive symptoms at T2 -- child/adolescent report
timeFrame: At entry (T0) and 30 days after the last psychotherapeutic session (intervention group) or 30 days after the last video is made available (active control group) (T2)
measure: The Clinical Global Impressions Scale
timeFrame: At entry (T0), 1-3 days after the last psychotherapeutic session (intervention group) OR 1-3 days after the last video is made available (active control group) (T1) and 30 days after these dates (T2)
measure: Children's Global Assessment Scale (CGAS)
timeFrame: At entry (T0), 1-3 days after the last psychotherapeutic session (intervention group) OR 1-3 days after the last video is made available (active control group) (T1) and 30 days after these dates (T2)
measure: impact of mental health symptomatology
timeFrame: At entry (T0), 1-3 days after the last psychotherapeutic session (intervention group) OR 1-3 days after the last video is made available (active control group) (T1) and 30 days after these dates (T2)
measure: Ecological Momentary Assessment of Emotional Problems
timeFrame: During the week prior to the beginning of the intervention and during the week after it
measure: Passive data collection
timeFrame: During the 5 weeks of the intervention until 30 days after the last psychotherapeutic session (intervention group) or 30 days after the last video is made available (active control group)
measure: Irritability
timeFrame: At entry (T0), 1-3 days after the last psychotherapeutic session (intervention group) OR 1-3 days after the last video is made available (active control group) (T1) and 30 days after these dates (T2)
measure: Parents satisfaction with the telepsychotherapeutic sessions
timeFrame: 1-3 days after the last psychotherapeutic session (intervention group only)
measure: primary measures of potential harm
timeFrame: At entry (T0), 1-3 days after the last psychotherapeutic session (intervention group) OR 1-3 days after the last video is made available (active control group) (T1) and 30 days after these dates (T2)
measure: secondary measures of potential harm
timeFrame: At entry (T0), 1-3 days after the last psychotherapeutic session (intervention group) OR 1-3 days after the last video is made available (active control group) (T1) and 30 days after these dates (T2)
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto de Psiquiatria do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Guilherme V Polanczyk, MD PhD
role: PRINCIPAL_INVESTIGATOR
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