Childhood Anxiety DisorderNCT05139433
Brief Internet-delivered Intervention for Children and Adolescents With Anxiety and Depression Symptoms
A study testing Telepsychotherapy and Psychoeducational Videos in people with Childhood Anxiety Disorder and Childhood Depression, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Childhood Anxiety Disorder, Childhood Depression
- What is being tested?
- Telepsychotherapy and Psychoeducational Videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Oct 2021to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Psiquiatria do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 05403-903
About this study
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
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.
Read the 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.
- Conditions
- Childhood Anxiety Disorder, Childhood Depression
- Being tested
- Telepsychotherapy, Psychoeducational Videos
- Keywords
- Children, Anxiety, Depression, Stress, Cognitive Behavioral Therapy, Telemedicine, Irritability, Covid-19 pandemic, Adolescents
- Medical subject headings
- Anxiety Disorders, Depression, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelepsychotherapyBehavioural
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"
Psychoeducational VideosBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in this arm will receive 5 internet-delivered cognitive-behavioral intervention and will have access to 15 educational videos Receives: Behavioral: Telepsychotherapy; Behavioral: Psychoeducational Videos |
| Active Control Group | Active comparator | Participants in this arm will have access to 15 educational videos. Receives: Behavioral: Psychoeducational Videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and depressive symptoms at T1- caregiver report
The first primary outcome is the change in depressive and anxiety symptomatology, measured by the 25-item version of the Revised Children's Anxiety and Depression Scale, parent reported, between T0 and T1. The RCADS is a 25-item scale that measures the frequency of anxiety and low mood symptoms using a 4-point Likert scale ("never", "sometimes", "often", and "always") based on personal observations from parents or legal guardians. The scale has two subscales assessing Anxiety and Depression, and an overall score. It will be completed by an independent clinician blinded to allocation based on an interview with the main caregiver (through videoconference or phone call).
Measured: 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)
Anxiety and depressive symptoms at T1 - child/adolescent report
The change in depressive and anxiety symptomatology, measured by the 25-item version of the Revised Children's Anxiety and Depression Scale (RCADS), child reported, between T0 and T1. This version of RCADS is a 25-item scale that measures the frequency of anxiety and low mood symptoms using a 4-point Likert scale ("never", "sometimes", "often", and "always") based on personal observations from the child. The scale has two subscales assessing Anxiety and Depression, and an overall score.It will be completed by an independent clinician blinded to allocation based on an interview with the child/adolescent (through videoconference or phone call).
Measured: 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 (11)
anxiety and depressive symptoms at T2 - parent report
The first secondary outcome is the change in depressive and anxiety symptomatology, measured by the 25-item version of the Revised Children's Anxiety and Depression Scale, parent report, between T0 and T2. This version of RCADS is a 25-item scale that measures the frequency of anxiety and low mood symptoms using a 4-point Likert scale ("never", "sometimes", "often", and "always") based on personal observations from parents or legal guardians. The scale has two subscales assessing Anxiety and Depression, and an overall score.
It will be fulfilled by the blind assessor, in an interview with the main caregiver (through videoconference or phone call).
Measured: 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)
anxiety and depressive symptoms at T2 -- child/adolescent report
The change in depressive and anxiety symptomatology, measured by the 25-item version of the Revised Children's Anxiety and Depression Scale (RCADS), child reported, between T0 and T2. This version of RCADS is a 25-item scale that measures the frequency of anxiety and low mood symptoms using a 4-point Likert scale ("never", "sometimes", "often", and "always") based on personal observations from the child. The scale has two subscales assessing Anxiety and Depression, and an overall score. It will be completed by an independent clinician blinded to allocation based on an interview with the child/adolescent (through videoconference or phone call).
Measured: 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)
The Clinical Global Impressions Scale
The blind assessor will evaluate the global functioning of the child/adolescent by an interview with the main caregiver and the child/adolescent (through videoconference or phone call) assessing the difference in scoring of the Clinical Global Impressions Scale - Severity (CGI-S) between T0 and T1 and T0 and T2 and the scoring of the Clinical Global Impressions Scale - Improvement (CGI-I) at T1 and T2. Scores of CGIS range from 1 to 7 (with higher scores corresponding to more intense symptomatology). Scores of CGI-I also range from 1 ("very much improved") to 7 ("very-much worse")
Measured: 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)
Children's Global Assessment Scale (CGAS)
the blind assessor will evaluate the global functioning of the child/adolescent by an interview with the main caregiver and the child/adolescent (through videoconference or phone call) assessing the difference in the scores of the Children's Global Assessment Scale (CGAS) at T0 and T1, and T0 and T2. CGAS scoring ranges from 0 to 100, with higher scores indicating better functionality.
Measured: 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)
impact of mental health symptomatology
The change of the impact of the child/adolescent mental health symptomatology between T0 and T1, and T0 and T2 will be assessed using the Strengths and Difficulties Questionnaire (SDQ) Impact Scale. Its score ranges from 0 to 10, with higher scores indicating greater severity of distress and impairment. It will be fulfilled by the blind assessor, in an interview with the main caregiver and the child/adolescent (through videoconference or phone call).
Measured: 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)
Ecological Momentary Assessment of Emotional Problems
Adolescents (12years-old or older) in both groups with access to a smartphone will complete a brief, in-the-moment assessment of emotions, mood, stress, and anxiety. Participants will receive a notification in their smartphone to answer a series of questions intended to reflect their current state ("Right now, I feel…"), with a 7-point Likert scale answer options (0 = Not at all, 7 = Very much). This Experience Sampling Method (ESM) schedule consists of 17 questions, taking up to 3min to complete. The ESM schedule will be delivered four random times per day within four three-hour blocks from 9:00 to 21:00 for six consecutive days in the week prior to the beginning of the intervention (first session, in the Intervention Group, and the availability of the first video, in the Active Control Group) and the week after the end of it (therefore, pre and post intervention).
Measured: During the week prior to the beginning of the intervention and during the week after it
Passive data collection
Adolescents (12years-old (or older) in both groups with access to a smartphone will be asked to install the pRMT app from RADAR-base. This app will run in the background, requiring minimal input from participants and will use the phone sensors to collect data on: a) ambient noise and light; b) relative GPS location (that is, the amount of distance travelled, not absolute coordinates or precise geographical location); c) bluetooth connectivity; d) length and duration of calls; e) number of text messages and emails; f) time spent using the smartphone; g) time spent on social media; and h) battery life.
Measured: 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)
Irritability
Changes in irritability reported by parents between T0 and T1, and T0 and T2, using the the Affective Reactivity Index (ARI), an index created to assess irritability, regarding their child. ARI is a 7 item scale (each scored with a 4 point likert scale), with higher scores corresponding to more severe irritability. It will be fulfilled by the blind assessor, in an interview with the main caregiver (through videoconference or phone call).
Measured: 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)
Parents satisfaction with the telepsychotherapeutic sessions
Parents will be requested to fulfill an adapted version of the Telemedicine Satisfaction Questionnaire (intervention group only) to assess their satisfaction with this form of psychotherapy It will be fulfilled by the blind assessor, in an interview with the main caregiver (through videoconference or phone call).
Measured: 1-3 days after the last psychotherapeutic session (intervention group only)
primary measures of potential harm
emergence of suicidality in the child/adolescent reported by parents in T1 and T2, using 4 questions of the Mood and Feelings Questionnaire ("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), regarding the past two weeks. It will be fulfilled by the blind assessor, in an interview with the main caregiver (through videoconference or phone call).
Measured: 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)
secondary measures of potential harm
worsening of the quality of family relationships.The family relationship subscale of the family impact module of the PedsQL will be completed by a caregiver at baseline and reassessed by the blind assessor in interviews (through videoconference or phone call) with the caregiver at T1 and T2.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start15 Oct 2021
- Primary completion25 May 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Childhood Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Guilherme Vanoni Polanczyk, MD PhD, University of Sao Paulo
- Investigators
- Guilherme V Polanczyk, MD PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139433
- Sponsor's protocol ID
- Proc. FAPESP 2016/22455-8
- Status last verified
- Jul 2023
- First submitted
- 4 Nov 2021
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
American Academy of Child and Adolescent Psychiatry (AACAP) Committee on Telepsychiatry and AACAP Committee on Quality Issues. Clinical Update: Telepsychiatry With Children and Adolescents. J Am Acad Child Adolesc Psychiatry. 2017 Oct;56(10):875-893. doi: 10.1016/j.jaac.2017.07.008. Epub 2017 Jul 25.
PubMed 28942810DeSousa DA, Stringaris A, Leibenluft E, Koller SH, Manfro GG, Salum GA. Cross-cultural adaptation and preliminary psychometric properties of the Affective Reactivity Index in Brazilian Youth: implications for DSM-5 measured irritability. Trends Psychiatry Psychother. 2013;35(3):171-80. doi: 10.1590/s2237-60892013000300004.
PubMed 25923389Ebesutani C, Korathu-Larson P, Nakamura BJ, Higa-McMillan C, Chorpita B. The Revised Child Anxiety and Depression Scale 25-Parent Version: Scale Development and Validation in a School-Based and Clinical Sample. Assessment. 2017 Sep;24(6):712-728. doi: 10.1177/1073191115627012. Epub 2016 Feb 1.
PubMed 26834091Matcham F, Barattieri di San Pietro C, Bulgari V, de Girolamo G, Dobson R, Eriksson H, Folarin AA, Haro JM, Kerz M, Lamers F, Li Q, Manyakov NV, Mohr DC, Myin-Germeys I, Narayan V, Bwjh P, Ranjan Y, Rashid Z, Rintala A, Siddi S, Simblett SK, Wykes T, Hotopf M; RADAR-CNS consortium. Remote assessment of disease and relapse in major depressive disorder (RADAR-MDD): a multi-centre prospective cohort study protocol. BMC Psychiatry. 2019 Feb 18;19(1):72. doi: 10.1186/s12888-019-2049-z.
PubMed 30777041Oar EL, Johnco C, Ollendick TH. Cognitive Behavioral Therapy for Anxiety and Depression in Children and Adolescents. Psychiatr Clin North Am. 2017 Dec;40(4):661-674. doi: 10.1016/j.psc.2017.08.002. Epub 2017 Sep 19.
PubMed 29080592Varni JW, Sherman SA, Burwinkle TM, Dickinson PE, Dixon P. The PedsQL Family Impact Module: preliminary reliability and validity. Health Qual Life Outcomes. 2004 Sep 27;2:55. doi: 10.1186/1477-7525-2-55.
PubMed 15450120Woerner W, Fleitlich-Bilyk B, Martinussen R, Fletcher J, Cucchiaro G, Dalgalarrondo P, Lui M, Tannock R. The Strengths and Difficulties Questionnaire overseas: evaluations and applications of the SDQ beyond Europe. Eur Child Adolesc Psychiatry. 2004;13 Suppl 2:II47-54. doi: 10.1007/s00787-004-2008-0.
PubMed 15243786Yip MP, Chang AM, Chan J, MacKenzie AE. Development of the Telemedicine Satisfaction Questionnaire to evaluate patient satisfaction with telemedicine: a preliminary study. J Telemed Telecare. 2003;9(1):46-50. doi: 10.1258/135763303321159693.
PubMed 12641893Casella CB, Farhat LC, Labbadia EM, Zuccolo PF, Fatori D, Argeu A, Salum GA, Polanczyk GV. Brief Internet-Delivered Cognitive-Behavioral Intervention for Children and Adolescents With Emotional Symptoms in Brazil: A Randomized Clinical Trial. J Adolesc Health. 2025 Sep;77(3):472-483. doi: 10.1016/j.jadohealth.2025.01.021. Epub 2025 Apr 2.
PubMed 40172510Casella CB, Zuccolo PF, Sugaya L, de Souza AS, Otoch L, Alarcao F, Gurgel W, Fatori D, Polanczyk GV. Brief internet-delivered cognitive-behavioural intervention for children and adolescents with symptoms of anxiety and depression during the COVID-19 pandemic: a randomised controlled trial protocol. Trials. 2022 Oct 22;23(1):899. doi: 10.1186/s13063-022-06836-2.
PubMed 36273162
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05139433
- Acronym / sponsor ID
- Proc. FAPESP 2016/22455-8
- Conditions
- Childhood Anxiety Disorder, Childhood Depression
- Keywords
- Children, Anxiety, Depression, Stress, Cognitive Behavioral Therapy, Telemedicine, Irritability, Covid-19 pandemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to be either in the intervention group (internet-based therapy) or the active control group (educational videos)
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Telepsychotherapy, Behavioral: Psychoeducational VideosParticipants in this arm will receive 5 internet-delivered cognitive-behavioral intervention and will have access to 15 educational videos |
| Active Control Group | Active comparator | Behavioral: Psychoeducational VideosParticipants in this arm will have access to 15 educational videos. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telepsychotherapy5 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" | Behavioural | Intervention Group |
| Psychoeducational Videos15 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. | Behavioural | Active Control Group, Intervention Group |
Primary outcome
Anxiety and depressive symptoms at T1- caregiver report
Time frame: 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)
The first primary outcome is the change in depressive and anxiety symptomatology, measured by the 25-item version of the Revised Children's Anxiety and Depression Scale, parent reported, between T0 and T1. The RCADS is a 25-item scale that measures the frequency of anxiety and low mood symptoms using a 4-point Likert scale ("never", "sometimes", "often", and "always") based on personal observations from parents or legal guardians. The scale has two subscales assessing Anxiety and Depression, and an overall score. It will be completed by an independent clinician blinded to allocation based on an interview with the main caregiver (through videoconference or phone call).
Anxiety and depressive symptoms at T1 - child/adolescent report
Time frame: 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)
The change in depressive and anxiety symptomatology, measured by the 25-item version of the Revised Children's Anxiety and Depression Scale (RCADS), child reported, between T0 and T1. This version of RCADS is a 25-item scale that measures the frequency of anxiety and low mood symptoms using a 4-point Likert scale ("never", "sometimes", "often", and "always") based on personal observations from the child. The scale has two subscales assessing Anxiety and Depression, and an overall score.It will be completed by an independent clinician blinded to allocation based on an interview with the child/adolescent (through videoconference or phone call).
11 secondary outcomes
anxiety and depressive symptoms at T2 - parent report
Time frame: 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)
anxiety and depressive symptoms at T2 -- child/adolescent report
Time frame: 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)
The Clinical Global Impressions Scale
Time frame: 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)
Children's Global Assessment Scale (CGAS)
Time frame: 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)
impact of mental health symptomatology
Time frame: 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)
Ecological Momentary Assessment of Emotional Problems
Time frame: During the week prior to the beginning of the intervention and during the week after it
Passive data collection
Time frame: 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)
Irritability
Time frame: 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)
Parents satisfaction with the telepsychotherapeutic sessions
Time frame: 1-3 days after the last psychotherapeutic session (intervention group only)
primary measures of potential harm
Time frame: 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)
secondary measures of potential harm
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Background: PubMed 28942810American Academy of Child and Adolescent Psychiatry (AACAP) Committee on Telepsychiatry and AACAP Committee on Quality Issues. Clinical Update: Telepsychiatry With Children and Adolescents. J Am Acad Child Adolesc Psychiatry. 2017 Oct;56(10):875-893. doi: 10.1016/j.jaac.2017.07.008. Epub 2017 Jul 25.
- Background: PubMed 25923389DeSousa DA, Stringaris A, Leibenluft E, Koller SH, Manfro GG, Salum GA. Cross-cultural adaptation and preliminary psychometric properties of the Affective Reactivity Index in Brazilian Youth: implications for DSM-5 measured irritability. Trends Psychiatry Psychother. 2013;35(3):171-80. doi: 10.1590/s2237-60892013000300004.
- Background: PubMed 26834091Ebesutani C, Korathu-Larson P, Nakamura BJ, Higa-McMillan C, Chorpita B. The Revised Child Anxiety and Depression Scale 25-Parent Version: Scale Development and Validation in a School-Based and Clinical Sample. Assessment. 2017 Sep;24(6):712-728. doi: 10.1177/1073191115627012. Epub 2016 Feb 1.
- Background: PubMed 30777041Matcham F, Barattieri di San Pietro C, Bulgari V, de Girolamo G, Dobson R, Eriksson H, Folarin AA, Haro JM, Kerz M, Lamers F, Li Q, Manyakov NV, Mohr DC, Myin-Germeys I, Narayan V, Bwjh P, Ranjan Y, Rashid Z, Rintala A, Siddi S, Simblett SK, Wykes T, Hotopf M; RADAR-CNS consortium. Remote assessment of disease and relapse in major depressive disorder (RADAR-MDD): a multi-centre prospective cohort study protocol. BMC Psychiatry. 2019 Feb 18;19(1):72. doi: 10.1186/s12888-019-2049-z.
- Background: PubMed 29080592Oar EL, Johnco C, Ollendick TH. Cognitive Behavioral Therapy for Anxiety and Depression in Children and Adolescents. Psychiatr Clin North Am. 2017 Dec;40(4):661-674. doi: 10.1016/j.psc.2017.08.002. Epub 2017 Sep 19.
- Background: PubMed 15450120Varni JW, Sherman SA, Burwinkle TM, Dickinson PE, Dixon P. The PedsQL Family Impact Module: preliminary reliability and validity. Health Qual Life Outcomes. 2004 Sep 27;2:55. doi: 10.1186/1477-7525-2-55.
- Background: PubMed 15243786Woerner W, Fleitlich-Bilyk B, Martinussen R, Fletcher J, Cucchiaro G, Dalgalarrondo P, Lui M, Tannock R. The Strengths and Difficulties Questionnaire overseas: evaluations and applications of the SDQ beyond Europe. Eur Child Adolesc Psychiatry. 2004;13 Suppl 2:II47-54. doi: 10.1007/s00787-004-2008-0.
- Background: PubMed 12641893Yip MP, Chang AM, Chan J, MacKenzie AE. Development of the Telemedicine Satisfaction Questionnaire to evaluate patient satisfaction with telemedicine: a preliminary study. J Telemed Telecare. 2003;9(1):46-50. doi: 10.1258/135763303321159693.
- Derived from this study: PubMed 40172510Casella CB, Farhat LC, Labbadia EM, Zuccolo PF, Fatori D, Argeu A, Salum GA, Polanczyk GV. Brief Internet-Delivered Cognitive-Behavioral Intervention for Children and Adolescents With Emotional Symptoms in Brazil: A Randomized Clinical Trial. J Adolesc Health. 2025 Sep;77(3):472-483. doi: 10.1016/j.jadohealth.2025.01.021. Epub 2025 Apr 2.
- Derived from this study: PubMed 36273162Casella CB, Zuccolo PF, Sugaya L, de Souza AS, Otoch L, Alarcao F, Gurgel W, Fatori D, Polanczyk GV. Brief internet-delivered cognitive-behavioural intervention for children and adolescents with symptoms of anxiety and depression during the COVID-19 pandemic: a randomised controlled trial protocol. Trials. 2022 Oct 22;23(1):899. doi: 10.1186/s13063-022-06836-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guilherme V Polanczyk, MD PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telepsychotherapy and Psychoeducational Videos in people with Childhood Anxiety Disorder and Childhood Depression, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and depressive symptoms at T1- caregiver report (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05139433, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.