scholarly journals Fatty Fish Intake and the Effect on Mental Health and Sleep in Preschool Children in FINS-KIDS, a Randomized Controlled Trial

Nutrients ◽  
2018 ◽  
Vol 10 (10) ◽  
pp. 1478 ◽  
Author(s):  
Mari Hysing ◽  
Ingrid Kvestad ◽  
Marian Kjellevold ◽  
Lisa Kolden Midtbø ◽  
Ingvild Graff ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Problems ◽  
Sleep Problems ◽  
Controlled Trial ◽  
Parent Report ◽  
Fatty Fish ◽  
Post Intervention ◽  
Dietary Compliance ◽  
Randomized Controlled

Mental health and sleep problems are prevalent in children during preschool years. The aim of the current study was to investigate if increased intake of fatty fish compared with meat improves mental health and sleep in four- to six-year-old children. The children (n = 232) in the two-armed randomized controlled trial, Fish Intervention Studies-KIDS (FINS-KIDS), were randomly assigned to lunch meals with fatty fish (herring/mackerel) or meat (chicken/lamb/beef) three times a week for 16 weeks. The fish and meat were weighed before and after the meals to record the exact consumption in grams (dietary compliance). Mental health problems were assessed by the strengths and difficulties questionnaire (SDQ) and sleep by parent report pre- and post-intervention. There was no significant statistical difference between changes in mental health and sleep for the fish eating group compared with the meat eating group, neither in the crude analysis nor after adjusting for intake of fish or meat (dietary compliance).

Design of the FINS-TEENS study: A randomized controlled trial assessing the impact of fatty fish on cognitive performance in adolescents

2017 ◽  
Vol 45 (6) ◽  
pp. 621-629 ◽  
Author(s):  
Siv Skotheim ◽  
Lisbeth Dahl ◽  
Katina Handeland ◽  
Livar Frøyland ◽  
Øyvind Lie ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Randomized Controlled Trial ◽  
Cognitive Performance ◽  
Controlled Trial ◽  
Fatty Fish ◽  
Post Intervention ◽  
Dietary Compliance ◽  
Randomized Controlled ◽  
Study Results ◽  
The Impact

Aims: To describe the rationale, study design, population and dietary compliance in a randomized controlled trial (RCT) investigating the effect of fatty fish on cognitive performance and mental health in adolescents. Method: In the Fish Intervention Studies-TEENS (FINS-TEENS) study we individually randomized 478 adolescents (14–15-year-olds) from eight secondary schools in Norway to receive school meal lunches with fatty fish or meat or n-3 supplements three times a week for 12 weeks. Demographic factors, psychological tests and biological measures were collected pre-and post-intervention. Duplicate portions of lunch meals were collected and individual intake recorded throughout the study. Results: In total, 481 out of 785 adolescents (61%) agreed to participate and 34 (7%) dropped out. Breakfast consumption was the only group difference in background characteristics. Analyses of selected nutrients in the lunch meals showed higher levels of n-3 fatty acids, vitamin D and n-6 fatty acids in the fish compared to the meat meals. Dietary compliance (score 0–144) revealed that the intake in the Fish group (mean = 59, standard deviation (SD) = 35) were lower than in the Meat group (mean = 83, SD = 31, p < 0.01) and Supplement group (mean = 105, SD = 25, p < 0.01). Conclusions: The results show that it is possible to conduct a RCT with fatty fish in a school-based setting. The results also emphasize the importance of collecting detailed records of dietary compliance, as this information is important when interpreting and analysing the outcome of dietary interventions.

scholarly journals COMmunity PARticipation through Education (COMPARE): effectiveness of supported education for students with mental health problems, a mixed methods study – study protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jacomijn Hofstra ◽  
Jorien van der Velde ◽  
Petra Jannette Havinga ◽  
Lies Korevaar
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Secondary Outcome ◽  
Study Success ◽  
Randomized Controlled ◽  
Supported Education

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.

scholarly journals A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter©

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Klajdi Puka ◽  
Karen Bax ◽  
Andrea Andrade ◽  
Margo Devries-Rizzo ◽  
Hema Gangam ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Family Environment ◽  
Intervention Program ◽  
Local Community ◽  
Mental Health Problems ◽  
Low Cost ◽  
Controlled Trial ◽  
Related Factors ◽  
Randomized Controlled

Abstract Background Epilepsy extends far beyond seizures; up to 80% of children with epilepsy (CWE) may have comorbid cognitive or mental health problems, and up to 50% of parents of CWE are at risk for major depression. Past research has also shown that family environment has a greater influence on children’s and parents’ health-related quality of life (HRQOL) and mental health than epilepsy-related factors. There is a pressing need for low-cost, innovative interventions to improve HRQOL and mental health for CWE and their parents. The aim of this randomized controlled trial (RCT) is to evaluate whether an interactive online mindfulness-based intervention program, Making Mindfulness Matter (M3), can be feasibly implemented and whether it positively affects CWE’s and parents’ HRQOL and mental health (specifically, stress, behavioral, depressive, and anxiety symptoms). Methods This parallel RCT was planned to recruit 100 child-parent dyads to be randomized 1:1 to the 8-week intervention or waitlist control and followed over 20 weeks. The intervention, M3, will be delivered online and separately to parents and children (ages 4–10 years) in groups of 4–8 by non-clinician staff of a local community epilepsy agency. The intervention incorporates mindful awareness, social-emotional learning skills, and positive psychology. It is modeled after the validated school-based MindUP program and adapted for provision online and to include a parent component. Discussion This RCT will determine whether this online mindfulness-based intervention is feasible and effective for CWE and their parents. The proposed intervention may be an ideal vector to significantly improve HRQOL and mental health for CWE and their parents given its low cost and implementation by community epilepsy agencies. Trial registration ClinicalTrials.gov NCT04020484. Registered on July 16, 2019. 

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

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).

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

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 (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).

scholarly journals 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)

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

scholarly journals Group intervention for siblings and parents of children with chronic disorders (SIBS-RCT): study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Krister W. Fjermestad ◽  
Wendy K. Silverman ◽  
Torun M. Vatne
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Family Communication ◽  
Neurodevelopmental Disorders ◽  
Group Intervention ◽  
Controlled Trial ◽  
Evidence Based ◽  
Post Intervention ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Siblings 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. Methods We 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. Discussion SIBS-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 registration ClinicalTrials.gov NCT04056884. Registered in August 2019

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