Twelve-month outcomes of MAKINGtheLINK: A cluster randomized controlled trial of a school-based program to facilitate help-seeking for substance use and mental health problems

Abstract Background The onset of mental health problems generally occurs between the ages of 16 and 23 – the years in which young people follow post-secondary education, which is a major channel in our society to prepare for a career and enhance life goals. Several studies have shown that students with mental health problems have a higher chance of early school leaving. Supported Education services have been developed to support students with mental health problems to remain at school. The current project aims to study the effect of an individually tailored Supported Education intervention on remaining at school, study success, and satisfaction of students with mental health problems studying at an institute for intermediate vocational education and a university of applied sciences in the Netherlands. Methods/design The design combines quantitative research (Randomized Controlled Trial; RCT) with qualitative research (monitoring, interviews, focus groups). One hundred students with mental health problems recruited from the two educational institutes will be randomly allocated to either the intervention or control condition. The students in the intervention condition receive the Supported Education intervention given by a Supported Education specialist, the students in the active control condition receive support as usual plus advice from a trained staff member on potential supportive resources regarding studying with mental health problems. The primary outcome ‘remaining at school’, and the secondary outcome ‘study success’ will be determined using data from the school’s administration. The secondary outcome ‘student satisfaction’ and other variables that will be studied in a more exploratory way, such as self-efficacy and study skills, will be determined through online questionnaires at baseline, at 6 and at 12 months follow-up. Focus groups and interviews with the students and Supported Education specialists will be carried out to complement the trial. Discussion This RCT is the first to assess the effect of Supported Education on remaining at school, next to study success and student satisfaction among students with mental health problems. The use of a mixed-methods design will result in a thorough evaluation of the effect of the intervention. Issues regarding the influx and possible attrition of students in the follow-up are discussed. Trial registration The study was registered with Trialregister.nl, no. NL8349, date registered: February 4th 2020. Register name: Community participation through education. Effectiveness of Supported Education for youth with mental health problems, a mixed methods study – Study protocol for a Randomized Controlled Trial. Protocol Version: 3, date: May 28th, 2021.

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Efficacy of a Web-Enabled, School-Based, Preventative Intervention to Reduce Bullying and Improve Mental Health in Children and Adolescents: Study Protocol for a Cluster Randomized Controlled Trial

Frontiers in Pediatrics ◽

10.3389/fped.2021.628984 ◽

2021 ◽

Vol 9 ◽

Author(s):

Covadonga M. Díaz-Caneja ◽

Javier Martín-Babarro ◽

Renzo Abregú-Crespo ◽

Miguel Á. Huete-Diego ◽

Marta Giménez-Dasí ◽

...

Keyword(s):

Quality Of Life ◽

Mental Health ◽

Randomized Controlled Trial ◽

Study Protocol ◽

Controlled Trial ◽

Bullying Victimization ◽

Randomized Controlled ◽

School Based ◽

Cluster Randomized

Introduction: Bullying is a major preventable risk factor for mental disorders. Available evidence suggests school-based interventions reduce bullying prevalence rates. This study aims to test the efficacy of a web-enabled, school-based, multicomponent anti-bullying intervention to prevent school bullying and to assess its effects on mental health and quality of life.Methods and analysis: Cluster randomized controlled trial conducted in 20 publicly funded primary and secondary schools in Madrid, Spain. Schools are randomly allocated to either the intervention arm (n = 10) or conventional practices arm (n = 10). The web-enabled intervention (LINKlusive) lasts ~12 weeks and consists of three main components: (i) an online training program for teachers and parents, (ii) a web-guided educational program for students, focusing on promoting respect for diversity, empathy, and social skill development, and (iii) a web-guided, teacher-delivered, targeted intervention program for bullying situations identified based on peer-support strategies and individual intervention for those involved (i.e., bullying victims and perpetrators). The primary objective is to compare differences between peer-reported bullying victimization in the intervention and control arms at the end of the intervention. Secondary outcome measures are additional measures of bullying victimization and perpetration, mental health symptoms, self-esteem, and quality of life. A follow-up assessment is conducted 1 year after the end of the intervention. Treatment effects will be tested using multilevel mixed models, adjusting for school-, classroom-, and student-related covariates. Considering the increased bullying rates in children with special educational needs, a specific subgroup analysis will test the efficacy of the intervention on bullying prevalence, mental health, and quality of life in this particularly vulnerable population.Ethics and Dissemination: The Deontology Commission of the School of Psychology, Universidad Complutense in Madrid, Spain reviewed the study protocol and granted ethical approval on 21st January 2019. The results of the trial will be disseminated in relevant peer-reviewed journals and at conferences in the field.Trial Registration Number: ISRCTN15719015.

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Protocol for an app-based affective control training for adolescents: proof-of-principle double-blind randomized controlled trial

Wellcome Open Research ◽

10.12688/wellcomeopenres.15229.1 ◽

2019 ◽

Vol 4 ◽

pp. 91

Author(s):

Susanne Schweizer ◽

Jovita T. Leung ◽

Rogier Kievit ◽

Maarten Speekenbrink ◽

William Trender ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Mental Health Problems ◽

Controlled Trial ◽

Health Problems ◽

Matching Task ◽

Double Blind ◽

Randomized Controlled ◽

The Impact ◽

Proof Of Principle

Background: 75% of all mental health problems have their onset before the end of adolescence. Therefore, adolescence may be a particularly sensitive time period for preventing mental health problems. Affective control, the capacity to engage with goal relevant and inhibit distracting information in affective contexts, has been proposed as a potential target for prevention. In this study, we will explore the impact of improving adolescents’ affective control capacity on their mental health. Methods: The proof-of-principle double-blind randomized controlled trial will compare the effectiveness of an app-based affective control training (AC-Training) to a placebo training (P-Training) app. In total, 200 (~50% females) adolescents (11-19 years) will train for 14 days on their training app. The AC-Training will include three different n-back tasks: visuospatial, auditory and dual (i.e., including both modalities). These tasks require participants to flexibly engage and disengage with affective and neutral stimuli (i.e., faces and words). The P-Training will present participants with a perceptual matching task. The three versions of the P-Training tasks vary in the stimuli included (i.e., shapes, words and faces). The two training groups will be compared on gains in affective control, mental health, emotion regulation and self-regulation, immediately after training, one month and one year after training. Discussion: If, as predicted, the proposed study finds that AC-Training successfully improves affective control in adolescents, there would be significant potential benefits to adolescent mental health. As a free app, the training would also be scalable and easy to disseminate across a wide range of settings. Trial registration: The trial was registered on December 10th 2018 with the International Standard Randomised Controlled Trial Number (Registration number: ISRCTN17213032).

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Protocol for an app-based affective control training for adolescents: proof-of-principle double-blind randomized controlled trial

Wellcome Open Research ◽

10.12688/wellcomeopenres.15229.2 ◽

2019 ◽

Vol 4 ◽

pp. 91 ◽

Cited By ~ 2

Author(s):

Susanne Schweizer ◽

Jovita T. Leung ◽

Rogier Kievit ◽

Maarten Speekenbrink ◽

William Trender ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Mental Health Problems ◽

Controlled Trial ◽

Health Problems ◽

Matching Task ◽

Double Blind ◽

Randomized Controlled ◽

The Impact ◽

Proof Of Principle

Background: 75% of all mental health problems have their onset before the end of adolescence. Therefore, adolescence may be a particularly sensitive time period for preventing mental health problems. Affective control, the capacity to engage with goal relevant and inhibit distracting information in affective contexts, has been proposed as a potential target for prevention. In this study, we will explore the impact of improving adolescents’ affective control capacity on their mental health. Methods: The proof-of-principle double-blind randomized controlled trial will compare the effectiveness of an app-based affective control training (AffeCT) to a placebo training (P-Training) app. In total, 200 (~50% females) adolescents (11-19 years) will train for 14 days on their training app. The AffeCT will include three different n-back tasks: visuospatial, auditory and dual (i.e., including both modalities). These tasks require participants to flexibly engage and disengage with affective and neutral stimuli (i.e., faces and words). The P-Training will present participants with a perceptual matching task. The three versions of the P-Training tasks vary in the stimuli included (i.e., shapes, words and faces). The two training groups will be compared on gains in affective control, mental health, emotion regulation and self-regulation, immediately after training, one month and one year after training. Discussion: If, as predicted, the proposed study finds that AffeCT successfully improves affective control in adolescents, there would be significant potential benefits to adolescent mental health. As a free app, the training would also be scalable and easy to disseminate across a wide range of settings. Trial registration: The trial was registered on December 10th 2018 with the International Standard Randomised Controlled Trial Number (Registration number: ISRCTN17213032).

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Effectiveness of a mobile phone-based intervention to reduce mental health problems in healthcare workers during the COVID-19 pandemic: A randomized controlled trial (PsyCovidApp trial) (Preprint)

10.2196/preprints.27039 ◽

2021 ◽

Author(s):

Maria Antònia Fiol-DeRoque ◽

Maria Jesús Serrano-Ripoll ◽

Rafael Jiménez ◽

Rocío Zamanillo-Campos ◽

Aina María Yáñez-Juan ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Posttraumatic Stress ◽

Healthcare Workers ◽

Primary Outcome ◽

Mental Health Problems ◽

Controlled Trial ◽

Health Problems ◽

Psychotropic Medications ◽

Randomized Controlled

BACKGROUND The global health emergency generated by the COVID-19 pandemic is posing an unprecedented challenge to healthcare workers (HCWs), who are facing heavy workloads under psychologically difficult situations. OBJECTIVE This trial aims to evaluate the effectiveness of a psychoeducational mobile Health (mHealth) intervention to reduce mental health problems in HCWs during the COVID-19 pandemic. METHODS We carried out a blinded randomized controlled trial. HCWs caring for COVID-19 patients in Spain were randomly assigned (1:1) by a computer-generated randomization sequence to the PsyCovidApp intervention (App targeting emotional skills, healthy lifestyle behavior, burnout, and social support) or a control App (general recommendations about mental healthcare). Data collection was conducted telephonically at baseline and two weeks. The primary endpoint was a composite of depression, anxiety, and stress. Secondary endpoints were insomnia, burnout, posttraumatic stress, self-efficacy, depression, anxiety, and stress. Differences between groups were analyzed using general linear modeling, according to an intention-to-treat protocol. RESULTS Between 14 May and 25 July 2020, 482 HCWs were randomly assigned to PsyCovidApp (n=248) or the control App (n=234). At two weeks, complete outcome data were available for 436 (91%) HCWs. No significant differences were observed between the groups at two weeks in the primary outcome (standardized mean difference -0.04 [95% CI -0.11 to 0.04]; p=0.15) and in the rest of the outcomes. In our prespecified subgroup analyses, we observed significant (p<0.05) improvements among HCWs consuming psychotropic medications in the primary outcome, and posttraumatic stress, insomnia, anxiety, and stress. Similarly, among HCWs receiving psychotherapy, we observed improvements in the primary outcome, insomnia, anxiety, and stress. CONCLUSIONS In HCWs assisting COVID-19 patients in Spain, PsyCovidApp, compared with a control App, reduced mental health problems at two weeks only among HCWs receiving psychotherapy or psychotropic medications. CLINICALTRIAL ClinicalTrials.gov NCT04393818

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