NCT05139433

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

Completed NA Last updated 25 July 2023

What this trial tests

NA trial testing Telepsychotherapy in Childhood Anxiety Disorder in 280 participants. Completed in 15 July 2023.

Timeline

15 October 2021

Primary endpoint
25 May 2023

15 July 2023

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	280
Start date	15 October 2021
Primary completion	25 May 2023
Estimated completion	15 July 2023
Sites	1 location across Brazil

Drugs / interventions tested

• Telepsychotherapy
• Psychoeducational Videos

Conditions studied

• Childhood Anxiety Disorder — all drugs for Childhood Anxiety Disorder →
• Childhood Depression — all drugs for Childhood Depression →

Sponsor

University of Sao Paulo

Who can join

Adults 8 to 17, any sex, with Childhood Anxiety Disorder or Childhood Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Casella CB, Zuccolo PF, Sugaya L, de Souza AS, et al · · 2022 · cited 3× · PMID 36273162 · DOI 10.1186/s13063-022-06836-2
2. Brief Internet-Delivered Cognitive-Behavioral Intervention for Children and Adolescents With Emotional Symptoms in Brazil: A Randomized Clinical Trial.
   Casella CB, Farhat LC, Labbadia EM, Zuccolo PF, et al · · 2025 · PMID 40172510 · DOI 10.1016/j.jadohealth.2025.01.021