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

Sponsor

University of Sao Paulo (Other)

Overall Status

Recruiting

CT.gov ID

NCT05139433

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

280

Enrollment

Location

Arms

17.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Anxiety Disorder Childhood Depression	Behavioral: Telepsychotherapy Behavioral: Psychoeducational Videos	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Outcomes Assessor)

Masking Description:

A trained clinical psychologist, blinded to which group the subject was allocated, will clinically assess the child/adolescent at T0, T1 and T2

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 15, 2021

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Participants in this arm will receive 5 internet-delivered cognitive-behavioral intervention and will have access to 15 educational videos	Behavioral: Telepsychotherapy 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" Behavioral: Psychoeducational Videos 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 Comparator: Active Control Group Participants in this arm will have access to 15 educational videos.	Behavioral: Psychoeducational Videos 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.

Arm

Intervention/Treatment

Experimental: Intervention Group

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

Behavioral: Telepsychotherapy

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"

Behavioral: Psychoeducational Videos

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 Comparator: Active Control Group

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

Behavioral: Psychoeducational Videos

Outcome Measures

Primary Outcome Measures

Anxiety and depressive symptoms at T1- caregiver report [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 [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).

Secondary Outcome Measures

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)]
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).
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 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).
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)]
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")
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)]
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.
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)]
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).
Ecological Momentary Assessment of Emotional Problems [During the week prior to the beginning of the intervention and during the week after it]
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).
Passive data collection [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)]
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.
Irritability [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)]
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).
Parents satisfaction with the telepsychotherapeutic sessions [1-3 days after the last psychotherapeutic session (intervention group only)]
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).
primary measures of potential harm [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)]
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).
secondary measures of potential harm [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)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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