- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05139433
Brief Internet-delivered Intervention for Children and Adolescents With Anxiety and Depression Symptoms
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guilherme V Polanczyk, MD PhD
- Phone Number: 551126617895
- Email: guilherme.polanczyk@hc.fm.usp.br
Study Contact Backup
- Name: Caio Casella
- Phone Number: 551126617895
- Email: caiobc94@gmail.com
Study Locations
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Sao Paulo, Brazil, 05403-903
- Instituto de Psiquiatria do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intervention Group
Participants in this arm will receive 5 internet-delivered cognitive-behavioral intervention and will have access to 15 educational videos
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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.
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Active Comparator: Active Control Group
Participants in this arm will have access to 15 educational videos.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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).
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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)
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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)
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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).
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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). |
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)
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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)
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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).
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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)
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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)
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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")
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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)
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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)
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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.
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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)
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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)
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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).
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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)
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Ecological Momentary Assessment of Emotional Problems
Time Frame: During the week prior to the beginning of the intervention and during the week after it
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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).
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During the week prior to the beginning of the intervention and during the week after it
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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)
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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.
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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)
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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)
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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).
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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)
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Parents satisfaction with the telepsychotherapeutic sessions
Time Frame: 1-3 days after the last psychotherapeutic session (intervention group only)
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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).
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1-3 days after the last psychotherapeutic session (intervention group only)
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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)
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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).
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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)
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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)
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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.
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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)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Guilherme V Polanczyk, MD PhD, University of Sao Paulo
Publications and helpful links
General Publications
- Varni 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.
- Matcham 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.
- 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.
- DeSousa 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.
- Ebesutani 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.
- Oar 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.
- Woerner 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.
- Yip 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.
- Casella 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Proc. FAPESP 2016/22455-8
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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