Dataset Information

Study protocol of an RCT of EMOTION: An indicated intervention for children with symptoms of anxiety and depression.

ABSTRACT: High levels of anxiety and depression are common psychological symptoms among children and adolescents. These symptoms affect young people in multiple life domains and are possible precursors of long-term psychological distress. Despite relatively high prevalence, few children with emotional problems are referred for clinical treatment, indicating the need for systematic prevention. The primary aim of this study is to evaluate an indicated preventive intervention, EMOTION Coping Kids Managing Anxiety and Depression (EMOTION), to reduce high levels of anxiety and depressive symptoms.This is a clustered randomized controlled trial involving 36 schools, which are assigned to one of two conditions: (a) group cognitive behavioral intervention EMOTION or (b) treatment as usual (TAU). Assessments will be undertaken at pre-, mid - intervention, post-, and one year after intervention. The children (8-11 years old) complete self-report questionnaires. Parents and teachers report on children. The primary outcome will be changes in depressive and anxiety symptoms as measured by the Short Mood and Feelings Questionnaire (SMFQ) and Multidimensional Anxiety Scale for Children (MASC) respectively. Secondary outcomes will be changes in self-esteem, quality of life, and school and daily functioning. Observers will assess implementation quality with ratings of fidelity based on video recordings of group leaders leading the EMOTION group sessions.The present study is an important contribution to the field regarding working with children with symptoms of anxiety and depression. The results of this study will provide an indication whether or not the EMOTION program is an effective intervention for the prevention of later depression and/or anxiety in children. The study will also provide information about the EMOTION program's effect on quality of life, self-esteem, and school functioning of the children participating in the study. Finally, the project will provide insight into implementation of an indicated intervention for school-aged children within Norwegian health, education, and mental health services.Clinical Trials NCT02340637 , Registered on June 12, 2014, last updated on January 15, 2015. Retrospectively registered.

SUBMITTER: Patras J

PROVIDER: S-EPMC5037866 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Study protocol of an RCT of EMOTION: An indicated intervention for children with symptoms of anxiety and depression.

Patras Joshua J Martinsen Kristin Dagmar KD Holen Solveig S Sund Anne Mari AM Adolfsen Frode F Rasmussen Lene-Mari Potulski LP Neumer Simon-Peter SP

BMC psychology 20160926 1

<h4>Background</h4>High levels of anxiety and depression are common psychological symptoms among children and adolescents. These symptoms affect young people in multiple life domains and are possible precursors of long-term psychological distress. Despite relatively high prevalence, few children with emotional problems are referred for clinical treatment, indicating the need for systematic prevention. The primary aim of this study is to evaluate an indicated preventive intervention, EMOTION Copi ...[more]

PMID: 27671742

Similar Datasets

Project description:BackgroundThe COVID-19 pandemic has had major impacts in many different spheres, including mental health. Children and adolescents are especially vulnerable because their central nervous system is still in development and they have fewer coping resources than do adults. Increases in the prevalence of depressive and anxiety symptomatology have been reported worldwide. However, access to mental health care is limited, especially for the paediatric population and in low- and middle-income countries. Therefore, we developed a brief internet-delivered cognitive-behavioural intervention for children and adolescents with symptoms of anxiety and depression. The aim of this proposed study is to test the efficacy of the intervention.MethodsWe will conduct a two-arm, parallel randomised controlled trial involving children and adolescents (8-11 and 12-17 years of age, respectively) with symptoms of anxiety, depression or both, according to the 25-item Revised Child Anxiety and Depression Scale (t-score > 70). A total of 280 participants will be randomised to the intervention group or the active control group, in a 1:1 ratio. Those in the intervention group will receive five weekly sessions of cognitive-behavioural therapy via teleconference. The sessions will focus on stress responses, family communication, diaphragmatic breathing, emotions, anger management, behavioural activation and cognitive restructuring. Participants in both groups will have access to 15 videos covering the same topics. Participant-guardian pairs will be expected to attend the sessions (intervention group), watch the videos (control group) or both (intervention group only). A blinded assessor will collect data on symptoms of anxiety, depression and irritability, at baseline, at the end of the intervention and 30 days thereafter. Adolescents with access to a smartphone will also be invited to participate in an ecological momentary assessment of emotional problems in the week before and the week after the intervention, as well as in passive data collection from existing smartphone sensors throughout the study.DiscussionInternet-delivered interventions play a major role in increasing access to mental health care. A brief, manualised, internet-delivered intervention might help children and adolescents with anxiety or depressive symptomatology, even outside the context of the COVID-19 pandemic.Trial registrationClinicalTrials.gov NCT05139433. Registered prospectively in November 2021. Minor amendments made in July 2022.

Project description:BACKGROUND:Living with elevated symptoms of depression can have debilitating consequences for an individual's psychosocial and physical functioning, quality of life, and health care utilization. A growing body of evidence demonstrates that skills for increasing positive emotion can be helpful to individuals with depression. Although Web-based interventions to reduce negative emotion in individuals with depression are available, these interventions frequently suffer from poor retention and adherence and do not capitalize on the potential benefits of increasing positive emotion. OBJECTIVE:The aim of this study was to develop and test a Web-based positive emotion skills intervention tailored for individuals living with elevated depressive symptoms, as well as to develop and test enhancement strategies for increasing retention and adherence to that intervention. METHODS:This study protocol describes the development and testing for Mobile Affect Regulation Intervention with the Goal of Lowering Depression (MARIGOLD), a Web-based positive emotion skills intervention, adapted for individuals with elevated depressive symptomatology. The intervention development is taking place in three phases. In phase 1, we are tailoring an existing positive emotion skills intervention for individuals with elevated symptoms of depression and are pilot testing the tailored version of the intervention in a randomized controlled trial with two control conditions (N=60). In phase 2, we are developing and testing three enhancements aimed at boosting retention and adherence to the Web-based intervention (N=75): facilitator contact, an online discussion board, and virtual badges. In phase 3, we are conducting a multifactorial, nine-arm pilot trial (N=600) to systematically test these enhancement strategies, individually and in combination. The primary outcome is depressive symptom severity. Secondary outcomes include positive and negative emotion, psychological well-being, and coping resources. RESULTS:The project was funded in August 2014, and data collection was completed in May 2018. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018. CONCLUSIONS:Findings from this investigation will enable us to develop an optimal package of intervention content and enhancement strategies for individuals with elevated symptoms of depression. If this intervention proves to be effective, it will provide a cost-effective, anonymous, appealing, and flexible approach for reducing symptoms of depression and improving psychological adjustment through increasing positive emotion. TRIAL REGISTRATION:ClinicalTrials.gov NCT01964820 (Phase 1); https://clinicaltrials.gov/ct2/show/NCT01964820 (Archived by WebCite at http://www.webcitation.org/6zpmKBcyX). ClinicalTrials.gov NCT02861755 (Phase 2); https://clinicaltrials.gov/ct2/show/NCT02861755 (Archived by WebCite at http://www.webcitation.org/6zpmLmy8k). REGISTERED REPORT IDENTIFIER:RR1-10.2196/10494.

Project description:BACKGROUND:Depression and anxiety are common and co-morbid disorders that affect a significant proportion of students. Innovative prevention strategies targeting both conditions are needed to reduce their health burden and costs. ICare Prevent is such an innovative strategy and contains a transdiagnostic individually tailored Internet-based and mobile-supported intervention. It addresses common risk factors of depression and anxiety as part of a large EU-funded multi-country project* (ICare). Little is known about the clinical and cost-effectiveness of this type of intervention compared to care as usual (CAU) for college students. We hypothesize that ICare Prevent will be more (cost-)effective than CAU in the reduction of symptoms of depression and anxiety. METHODS:A three-arm, parallel, randomized controlled superiority trial will be conducted comparing a guided and an unguided version of ICare Prevent with a control group receiving CAU. The trial will be open-label but outcome assessors will be blinded. A total of 252 college students (age???16 years) with subclinical symptoms of depression defined as a score???16 on the Center for Epidemiological Studies Depression Scale (CES-D), and/or anxiety, defined as a score???5 on the Generalized Anxiety Disorder scale (GAD-7), will be included. Those meeting diagnostic criteria for a depressive or anxiety disorder will be excluded. The primary outcome is change in disorder specific symptom severity from baseline to post-intervention. Secondary endpoints include self-reported depression and anxiety symptoms as well as time to onset of a mood or anxiety disorder until 12-month follow-up. Societal costs and quality of life will be assessed to estimate the intervention's cost-effectiveness compared to CAU. DISCUSSION:Transdiagnostic individually tailored Internet-based prevention could be a (cost-)effective approach to tackle the disease burden of depression and anxiety among college students. TRIAL REGISTRATION:Dutch trial register, NTR 6562 . Registered on 6 July 2017.

Project description:BackgroundSiblings and parents of children with neurodevelopmental disorders are at risk of mental health problems and poorer family communication. Some group interventions for siblings exist, but few have clearly described parent components and none are considered evidence-based.MethodsWe are conducting a randomized controlled trial comparing a five-session manual-based group intervention for siblings (aged 8 to 16 years) and parents of children with neurodevelopmental disorders to a 12-week waitlist, called SIBS-RCT. The intervention comprises three separate sibling and parent group sessions and two joint sessions in which each sibling talks to their parent alone. The intervention aims at improving parent-child communication and covers themes such as siblings' understanding of the neurodevelopmental disorder, siblings' emotions, and perceived family challenges. Participants are recruited through municipal and specialist health centers across Norway. The primary outcome is sibling mental health. Quality of life and family communication are secondary outcomes. Participants are block-randomized to the intervention or 12-week waitlist in groups of six. Measures are collected electronically at pre- and post-intervention/waitlist, as well as 3, 6, and 12 months post-intervention. The main effect to be examined is the difference between the intervention and waitlist at 12 weeks post. All outcomes will also be examined using growth curve analyses. We plan to include 288 siblings and their parents by the end of 2022.DiscussionSIBS-RCT represents a major contribution to the research and practice field towards establishing an evidence-based intervention for siblings. In the event that intervention and waitlist are no different, the impact of SIBS-RCT is still substantial in that we will aim to identify participant subgroups that show positive response and effective components of the SIBS manual by examining group leader adherence as an outcome predictor. This will allow us to continue to re-engineer the SIBS manual iteratively to improve outcomes, and avoid the promotion of a less-than-optimal intervention.Trial registrationClinicalTrials.gov NCT04056884 . Registered in August 2019.

Dataset Information

Study protocol of an RCT of EMOTION: An indicated intervention for children with symptoms of anxiety and depression.

Publications

Study protocol of an RCT of EMOTION: An indicated intervention for children with symptoms of anxiety and depression.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets