Brief Internet-delivered Intervention for Children and Adolescents With Anxiety and Depression Symptoms

NCT05139433 | Completed

• 1 other identifier: Proc. FAPESP 2016/22455-8
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Anxiety Disorder; Childhood Depression

Keywords

Children; Anxiety; Depression; Stress; Cognitive Behavioral Therapy; Telemedicine; Irritability; Covid-19 pandemic; Adolescents

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  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

  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

  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

  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)

  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

  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)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in this arm will receive 5 internet-delivered cognitive-behavioral intervention and will have access to 15 educational videos

Behavioral: Telepsychotherapy; Behavioral: Psychoeducational Videos

Active Control Group

ACTIVE COMPARATOR

Participants in this arm will have access to 15 educational videos.

Behavioral: Psychoeducational Videos

Interventions

Telepsychotherapy BEHAVIORAL

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"

Intervention Group

Psychoeducational Videos BEHAVIORAL

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.

Active Control Group; Intervention Group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Instituto de Psiquiatria do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 05403-903, Brazil

Location

Related Publications (10)

• 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.

  PMID: 28942810 BACKGROUND

• 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.

  PMID: 25923389 BACKGROUND

• 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.

  PMID: 26834091 BACKGROUND

• 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.

  PMID: 30777041 BACKGROUND

• 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.

  PMID: 29080592 BACKGROUND

• 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.

  PMID: 15450120 BACKGROUND

• 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.

  PMID: 15243786 BACKGROUND

• 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.

  PMID: 12641893 BACKGROUND

• Casella 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.

  PMID: 40172510 DERIVED

• 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.

  PMID: 36273162 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; COVID-19

Interventions

Mental Health Teletherapy

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Guilherme V Polanczyk, MD PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A trained clinical psychologist, blinded to which group the subject was allocated, will clinically assess the child/adolescent at T0, T1 and T2
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized to be either in the intervention group (internet-based therapy) or the active control group (educational videos)

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: December 1, 2021
• Study Start: October 15, 2021
• Primary Completion: May 25, 2023
• Study Completion: July 15, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

BR (1)