Communicating prognosis to parents in the neonatal ICU: Optimistic vs. PEssimistic – “The “COPE”-Trial“ – Study protocol of a randomized controlled trial using scripted video-vignettes to explore communication preferences of parents of preterm infants

2021 ◽  
Author(s):  
Fiona A. Forth ◽  
Florian Hammerle ◽  
Jochem König ◽  
Michael S. Urschitz ◽  
Philipp Neuweiler ◽  
...  
Keyword(s):  
Online Survey ◽  
Medical Center ◽  
Controlled Trial ◽  
Patient Questionnaire ◽  
Online Questionnaire ◽  
Post Intervention ◽  
Parent Communication ◽  
Communication Preferences ◽  
Randomized Controlled ◽  
Video Vignettes

Abstract Background: One of the numerous challenges preterm birth poses for parents and physicians is prognostic disclosure. Prognoses are based on scientific evidence and medical experience. They are subject to individual assessment and, hence, will generally remain uncertain with regard to the individual. This can result in differences in prognostic framing and thus affect the recipients’ perception. In neonatology, data on the effects of prognostic framing are scarce. In particular, it is unclear whether parents prefer a more optimistic or a more pessimistic prognostic framing.Objective: To explore parents’ preferences concerning prognostic framing and its effects on parent reported outcomes and experiences. To identify predictors (demographic, psychological) of parents’ communication preferences.Design, setting, participants: Unblinded, randomized-controlled cross-over trial (RCT) at the Division of Neonatology of the University Medical Center Mainz, Germany, including German-speaking parents or guardians of infants born preterm between 2009 and 2019 with a birth weight <1500g. Inclusion of up to 204 families is planned, with possible reduction according to a blinded sample size reassessment after enrollment of 50 to 70 families, depending on the number of participants per family.Intervention: Embedded in an online-survey and in pre-specified order, participants will watch two video-vignettes depicting a more optimistic vs. a more pessimistic framing in prognostic disclosure to parents of a preterm infant. Apart from prognostic framing, all other aspects of physician-parent communication are standardized in both videos.Main outcomes and measures: At baseline and after each video, participants complete a two-part online-questionnaire (baseline and post-intervention). Primary outcome is the preference for either a more optimistic or a more pessimistic prognostic framing. Secondary outcomes include changes in state-anxiety (STAI-SKD), satisfaction with framing, evaluation of prognosis, future optimism and hope, preparedness for shared decision-making (each assessed using customized questions), and general impression (customized question), professionalism (adapted from GMC Patient Questionnaire) and compassion (Physician Compassion Questionnaire) of the consulting physician.Discussion: This RCT will explore parents’ preferences concerning prognostic framing and its effects on physician-parent communication. Results may contribute to a better understanding of parental needs in prognostic disclosure and will be instrumental for a broad audience of clinicians, scientists and ethicists.Trial registration: drks.de DRKS00024466. Registered on April 16, 2021

scholarly journals The COPE-Trial—Communicating prognosis to parents in the neonatal ICU: Optimistic vs. PEssimistic: study protocol for a randomized controlled crossover trial using two different scripted video vignettes to explore communication preferences of parents of preterm infants

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fiona A. Forth ◽  
Florian Hammerle ◽  
Jochem König ◽  
Michael S. Urschitz ◽  
Philipp Neuweiler ◽  
...  
Keyword(s):  
Online Survey ◽  
Crossover Trial ◽  
Medical Center ◽  
Patient Questionnaire ◽  
Online Questionnaire ◽  
Post Intervention ◽  
Parent Communication ◽  
Communication Preferences ◽  
Randomized Controlled ◽  
Video Vignettes

Abstract Background One of the numerous challenges preterm birth poses for parents and physicians is prognostic disclosure. Prognoses are based on scientific evidence and medical experience. They are subject to individual assessment and will generally remain uncertain with regard to the individual. This can result in differences in prognostic framing and thus affect the recipients’ perception. In neonatology, data on the effects of prognostic framing are scarce. In particular, it is unclear whether parents prefer a more optimistic or a more pessimistic prognostic framing. Objective To explore parents’ preferences concerning prognostic framing and its effects on parent-reported outcomes and experiences. To identify predictors (demographic, psychological) of parents’ communication preferences. Design, setting, participants Unblinded, randomized controlled crossover trial (RCT) at the Division of Neonatology of the University Medical Center Mainz, Germany, including German-speaking parents or guardians of infants born preterm between 2010 and 2019 with a birth weight < 1500 g. Inclusion of up to 204 families is planned, with possible revision according to a blinded sample size reassessment. Intervention Embedded in an online survey and in pre-specified order, participants will watch two video vignettes depicting a more optimistic vs. a more pessimistic framing in prognostic disclosure to parents of a preterm infant. Apart from prognostic framing, all other aspects of physician-parent communication are standardized in both videos. Main outcomes and measures At baseline and after each video, participants complete a two-part online questionnaire (baseline and post-intervention). Primary outcome is the preference for either a more optimistic or a more pessimistic prognostic framing. Secondary outcomes include changes in state-anxiety (STAI-SKD), satisfaction with prognostic framing, evaluation of prognosis, future optimism and hope, preparedness for shared decision-making (each assessed using customized questions), and general impression (customized question), professionalism (adapted from GMC Patient Questionnaire) and compassion (Physician Compassion Questionnaire) of the consulting physician. Discussion This RCT will explore parents’ preferences concerning prognostic framing and its effects on physician-parent communication. Results may contribute to a better understanding of parental needs in prognostic disclosure and will be instrumental for a broad audience of clinicians, scientists, and ethicists. Trial registration German Clinical Trials Register DRKS00024466. Registered on April 16, 2021.

scholarly journals Meditation Monologue can Reduce Clinical Injection-Related Anxiety: Randomized Controlled Trial

2021 ◽  
Vol 26 ◽  
pp. 2515690X2110060
Author(s):  
Dai Sugimoto ◽  
Nathalie R. Slick ◽  
David L. Mendel ◽  
Cynthia J. Stein ◽  
Emily Pluhar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
New England ◽  
Trait Anxiety ◽  
Mobile Application ◽  
Sports Medicine ◽  
Medical Center ◽  
Controlled Trial ◽  
Intervention Group ◽  
Post Intervention ◽  
Randomized Controlled

Background. Strategies to reduce anxiety prior to injection procedures are not well understood. The purpose is to determine the effect of a meditation monologue intervention delivered via phone/mobile application on pre-injection anxiety levels among patients undergoing a clinical injection. The following hypothesis was tested: patients who listened to a meditation monologue via phone/mobile application prior to clinical injection would experience less anxiety compared to those who did not. Methods. A prospective, randomized controlled trial was performed at an orthopedics and sports medicine clinic of a tertiary level medical center in the New England region, USA. Thirty patients scheduled for intra- or peri-articular injections were randomly allocated to intervention (meditation monologue) or placebo (nature sounds) group. Main outcome variables were state and trait anxiety inventory (STAI) scores and blood pressure (BP), heart rate, and respiratory rate. Results. There were 16 participants who were allocated to intervention (meditation monologue) while 14 participants were assigned to placebo (nature sounds). There was no interaction effect. However, a main time effect was found. Both state anxiety (STAI-S) and trait anxiety (STAI-T) scores were significantly reduced post-intervention compared to pre-intervention (STAI-S: p = 0.04, STAI-T: p = 0.04). Also, a statistically significant main group effect was detected. The pre- and post- STAI-S score reduction was greater in the intervention group (p = 0.028). Also, a significant diastolic BP increase between pre- and post-intervention was recorded in the intervention group (p = 0.028), but not in the placebo group (p = 0.999). Conclusion. Listening to a meditation monologue via phone/mobile application prior to clinical injection can reduce anxiety in adult patients receiving intra- and peri-articular injections. Registration: ClinicalTrials.gov NCT02690194

scholarly journals Boxing vs Sensory Exercise for Parkinson’s Disease: A Double-Blinded Randomized Controlled Trial

2021 ◽  
pp. 154596832110231
Author(s):  
Kishoree Sangarapillai ◽  
Benjamin M. Norman ◽  
Quincy J. Almeida
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Randomized Controlled Trial ◽  
Repeated Measures ◽  
Rating Scale ◽  
Controlled Trial ◽  
Motor Symptoms ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Double Blinded

Background. Exercise is increasingly becoming recognized as an important adjunct to medications in the clinical management of Parkinson’s disease (PD). Boxing and sensory exercise have shown immediate benefits, but whether they continue beyond program completion is unknown. This study aimed to investigate the effects of boxing and sensory training on motor symptoms of PD, and whether these benefits remain upon completion of the intervention. Methods. In this 20-week double-blinded randomized controlled trial, 40 participants with idiopathic PD were randomized into 2 treatment groups, (n = 20) boxing or (n = 20) sensory exercise. Participants completed 10 weeks of intervention. Motor symptoms were assessed at (week 0, 10, and 20) using the Unified Parkinson’s Disease Rating Scale (UPDRS-III). Data were analyzed using SPSS, and repeated-measures ANOVA was conducted. Results. A significant interaction effect between groups and time were observed F(1, 39) = 4.566, P = .036, where the sensory group improved in comparison to the boxing group. Post hoc analysis revealed that in comparison to boxing, the effects of exercise did not wear off at washout (week 20) P < .006. Conclusion. Future rehabilitation research should incorporate similar measures to explore whether effects of exercise wear off post intervention.

scholarly journals Adherence to a Lifestyle Exercise and Nutrition Intervention in University Employees during the COVID-19 Pandemic: A Randomized Controlled Trial

2021 ◽  
Vol 18 (14) ◽  
pp. 7510
Author(s):  
Guillermo García Pérez de Sevilla ◽  
Olga Barceló Guido ◽  
María de la Paz De la Cruz ◽  
Ascensión Blanco Fernández ◽  
Lidia B. Alejo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Effect Size ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Nutrition Intervention ◽  
Sitting Time ◽  
Post Intervention ◽  
University Employees ◽  
Randomized Controlled

Healthy lifestyles should be encouraged in the workplace through the occupational health teams of the companies. The objective of the present study was to evaluate the adherence to a lifestyle intervention carried out in university employees during the COVID-19 pandemic and its impact on health-related quality of life (HrQoL). A randomized controlled trial following the CONSORT guidelines was performed, consisting of three supervised interventions lasting for 18 weeks: an educational intervention on healthy habits, a nutritional intervention, and a telematic aerobic and strength exercise intervention. Lifestyle and HrQoL were analyzed six months post-intervention to assess adherence. Twenty-three middle-aged participants completed the study. The intervention group significantly improved their lifestyle according to the Health Promoting Lifestyle Profile II questionnaire, especially in the categories of Health Responsibility, Physical Activity, and Nutrition, with a large effect size. Sitting time was reduced by 2.5 h per day, with a moderate effect size. Regarding HrQoL, the intervention group showed a clinically significant improvement in the Physical Component Summary. Despite the lockdown and the mobility restrictions caused by the COVID-19 pandemic, this intervention performed on university employees achieved adherence to a healthier lifestyle and improved their HrQoL, which is of great clinical relevance.

scholarly journals The impact of theory-based messages on COVID-19 vaccination intentions: a structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ben Young ◽  
Marie Kotzur ◽  
Lauren Gatting ◽  
Carissa Bonner ◽  
Julie Ayre ◽  
...  
Keyword(s):  
Online Survey ◽  
Controlled Trial ◽  
Significant Proportion ◽  
General Information ◽  
School Level ◽  
Text And Image ◽  
Post Intervention ◽  
Full Protocol ◽  
The Impact ◽  
Illness Coherence

Abstract Objectives Uptake of vaccination against COVID-19 is key to controlling the pandemic. However, a significant proportion of people report that they do not intend to have a vaccine, often because of concerns they have about vaccine side effects or safety. This study will assess the impact of theory-based messages on COVID-19 vaccination intention, drawing on the Necessity-Concerns framework to address previously reported beliefs and concerns about COVID-19 vaccination, and assess whether hypothesised variables (illness coherence, perceived necessity and concerns) mediate change in vaccination intention. Trial design Prospective, parallel two-arm, individually randomised (1:1) trial. Participants Adults aged over 18 years, living in Scotland and not vaccinated for COVID-19. A quota sampling approach will be used with the aim of achieving a nationally representative sample on gender, region and ethnic group, with oversampling of individuals with no educational qualifications or with only school-level qualifications. Intervention and comparator Intervention: Brief exposure to online text and image-based messages addressing necessity beliefs and concerns about COVID-19 vaccination. Comparator: Brief exposure to online text and image-based messages containing general information about COVID-19 and COVID-19 vaccination. Main outcomes Primary outcome: Self-reported intention to receive a vaccine for COVID-19 if invited, immediately post-intervention. Secondary outcomes: Self-reported COVID-19 illness coherence, perceived necessity of a COVID-19 vaccine and concerns about a COVID-19 vaccine, immediately post-intervention. Randomisation Quasi-randomisation performed automatically by online survey software, by creating a variable derived from the number of seconds in the minute that the participant initiates the survey. Participants starting the survey at 0-14 or 30-44 seconds in the minute are allocated to the intervention and 15-29 or 45-59 seconds to the comparator. Blinding (masking) Participants will not be blinded to group assignment but will not be informed of the purpose of the study until they have completed the follow-up survey. Investigators will be blinded to allocation as all procedures will be undertaken digitally and remotely without any investigator contact with participants. Numbers to be randomised (sample size) A total of 1,094 will be randomised 1:1 into two groups with 547 individuals in each. Trial Status Protocol version number 1.0, 26th February 2021. Recruitment status: Not yet recruiting, set to start April 2021 and end April 2021. Trial registration ClinicalTrials.gov, NCT04813770, 24th March 2021. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals Equol effects on AGE skin products, visceral fat and climacteric symptoms in post-menopausal women: A randomized controlled trial

2021 ◽  
Author(s):  
Remi Yoshikata ◽  
Khin Zay Yar Myint ◽  
Hiroaki Ohta ◽  
Yoko Ishigaki
Keyword(s):  
Randomized Controlled Trial ◽  
Visceral Fat ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Climacteric Symptoms ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Menopausal Women ◽  
Post Menopausal

Abstract Introduction: Equol, an isoflavone derivative whose chemical structure is similar to estrogen, is considered as a potentially effective agent for relieving climacteric symptoms, for the prevention of the lifestyle-related diseases, and for aging care in post-menopausal women. We investigated the effect of an equol-containing supplement on metabolism and aging, and climacteric symptoms, with respect to internally-produced equol in post-menopausal women.Methods: A single center, randomized controlled trial (registration number: UMIN000030975) on 57 post-menopausal Japanese women (mean age: 56±5.37 years), was conducted. Twenty-seven women received the equol supplement, while the remaining received Control. Metabolic and aging-related biomarkers were compared before and after the 3-month intervention. Climacteric symptoms were assessed every month using a validated self-administered questionnaire in Japanese post-menopausal women. Results: Three months post intervention, the treatment group showed significant improvement in climacteric symptoms, when compared to the Control group (81% vs. 53% respectively, p=0.045). We did not observe any beneficial effect on metabolic and aging-related biomarkers in the intervention group. However, in certain populations significant improvement in skin auto-fluorescence, which is a measurement of AGE skin products, and visceral fat area was observed, especially among equol producers. Conclusion: Women receiving equol supplement showed improved climacteric symptoms. This study offered a new hypothesis that there may be a synergy between supplemented equol and endogenously-produced equol to improve skin aging and visceral fat in certain populations.

scholarly journals PREWARMING FOR PREVENTION OF PERIOPERATIVE HYPOTHERMIA IN PATIENTS WITH COMBINED EPIDURAL AND GENERAL ANESTHESIA: A RANDOMIZED CONTROLLED TRIAL

2021 ◽  
Author(s):  
Dang Tinh Pham ◽  
Thi Ngoc Le ◽  
Ton Ngoc Vu Phan ◽  
Parshal Bhandari ◽  
Sairah Zia ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
General Anesthesia ◽  
Outcome Measures ◽  
Medical Center ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Perioperative Hypothermia ◽  
Randomized Controlled ◽  
Physical Status Classification ◽  
American Society

OBJECTIVE The aim of this study was to access the influence of active warming after epidural anesthesia (EDA) and before general anesthesia in prevention of perioperative hypothermia. METHOD This randomized controlled trial was conducted in the department of anesthesiology in university medical center of Ho Chi Minh city, Vietnam from December 2019 until April 2020. This trial included 60 adult patients who were scheduled for major abdominal surgery with a duration of at least 120 minutes and under combined general anesthesia and EDA. Patients were excluded if age was below 18 years, American Society Anesthesiologists’ physical status classification of IV or higher, or refusal of EDA. Written informed consent was obtained for all patients. Patients were divided randomly into two groups. The first group received 10 minutes of active air-forced warming after EDA before the induction of general anesthesia. The second group was covered with a blanket 10 minutes after EDA and before general anesthesia. Core temperatures were recorded throughout the study. The primary outcome measures were the incidence of perioperative hypothermia and the degree of hypothermia. The secondary outcome measures were rate and time for body temperature to return to normal and incidence of postoperative body shivering. RESULTS Without active warming (n = 21), 70% of patients became hypothermic (<36°C) postoperatively. Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia decreased the incidence of postoperative hypothermia to 26.7% (n = 8). CONCLUSION Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia is efficient in reducing the incidence of perioperative hypothermia.

Effects of Guitar Accompaniment Patterns on Hospitalized Infants: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Kory Antonacci ◽  
Nicole Steele ◽  
Jacob Wheatley ◽  
Donna M Weyant ◽  
Beverly Brozanski ◽  
...  
Keyword(s):  
Heart Rate ◽  
Randomized Controlled Trial ◽  
Music Therapy ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Pain Scale ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Stressful Environment ◽  
The Difference

Abstract A neonatal intensive care unit (NICU) can be an extremely stressful environment for infants receiving complex medical care at a pediatric facility. Music therapy can help address the stressful environment by increasing comfort and relaxation as well as decreasing a patient’s physiological response of heart rate and respiratory rate. A randomized controlled trial was completed, examining the effects of 2 guitar accompaniment patterns on infants (an arpeggiated pattern and a bass/chord pattern) in a NICU. There were 180 infants enrolled with mean chronological ages of 7.4 ± 6.1 weeks and postmenstrual ages (gestational age at birth + their chronological age) of 39.8 ± 7.9 weeks. All subject enrollees participated in a 12-minute initial music therapy session. Outcome measures included heart rate, respirations, and comfort responses. The results of the research study demonstrated that the arpeggiated guitar pattern had a lower mean heart rate and respiratory across all 3 data points (pre, during, and post intervention); however, the difference in means between the 2 accompaniment pattern groups was not statistically significant. Using the Neonatal Infant Pain Scale (NIPS) to measure comfort response, the results demonstrated no difference between the 2 group accompaniment patterns. Although the results show no significant differences among accompaniment pattern groups, the researchers describe the clinical significance that supports the use of both accompaniment patterns as suitable interventions for infants in the NICU receiving music therapy intervention.

scholarly journals Effectiveness of using a meditation app in reducing anxiety and improving well-being during the COVID-19 pandemic: A structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Katherine T. O’Donnell ◽  
Melanie Dunbar ◽  
Diana L. Speelman
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Intervention Period ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Survey Questions ◽  
Full Protocol ◽  
Allocation Ratio ◽  
Survey Responses

Abstract Objectives This interventional study will investigate the effect of daily use of a mindfulness app on measures of participant anxiety, well-being, and perceived outlook during the COVID-19 pandemic, by comparing pre-intervention survey responses to post-intervention survey responses. Trial design Randomized, controlled trial with parallel assignment. Adults will be assigned either to daily use of a meditation app for 30 days or to a control group (no usage of meditation app) with a 1:1 equivalence allocation ratio. Participants Inclusion Criteria: Participants must be 18 or older, have a smartphone, able to download apps to their smartphone, must be fluent in the English language, able to complete surveys on their own, and must be in the United States for the duration of the study. Exclusion Criteria: Current regular use of a mindfulness or meditation app, regular practice of mindfulness or meditation, regular therapy sessions, inability to complete surveys independently, or any mental health restrictions that would prevent participation. All data will be collected through the Insight Timer Meditation App and Google Forms. This trial is being conducted through the Lake Erie College of Osteopathic Medicine in Erie, PA, with all data collected digitally. Intervention and comparator Intervention: Participants will be sent a link to a pre-intervention survey prior to first use of the mindfulness app. Participants will be instructed to use the Insight Timer app for 10 minutes daily for 30 days. At the end of the 30-day intervention period, participants will be sent a link for the post-intervention survey. Two months after the conclusion of the 30-day intervention period, participants will be sent a link for another post-intervention survey. Comparator: Participants will receive the same surveys, but will not use any mindfulness app for the 30-day intervention period. After this 30-day period, participants are invited to use the Insight Timer app if they so choose. Main outcomes The main outcomes are (1) anxiety as assessed by survey questions adapted from the GAD7, comparing pre-intervention to post-30-days of app usage and (2) well-being as assessed by survey questions adapted from the WHO-5, comparing pre-intervention and post-30-days of app usage. Randomization Participants will be allocated to interventions via a block random sequence generator with a 1:1 allocation ratio in blocks of 8. Blinding (masking) No masking is being used in this study (open label). Numbers to be randomized (sample size) Approximately 75 participants will be randomized to each group, with an estimated enrollment of 150 participants. Trial status This study is protocol version number 27-126 and was approved on May 10, 2020. Recruitment began on August 19, 2020 and will end February 28, 2021. The study is estimated to complete on April 30, 2021. Trial registration This trial was registered to ClinicalTrials.gov on 30 April 2020. The ClinicalTrials.gov Identifier is NCT04369378. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional File 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals The Effectiveness of a Community-Based Mentoring Program for Children Aged 5–11 Years: Results from a Randomized Controlled Trial

2020 ◽  
Vol 22 (1) ◽  
pp. 100-112 ◽  
Author(s):  
Nick Axford ◽  
Gretchen Bjornstad ◽  
Justin Matthews ◽  
Laura Whybra ◽  
Vashti Berry ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Causal Effect ◽  
Controlled Trial ◽  
Well Being ◽  
Mentoring Program ◽  
Post Intervention ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Average Causal Effect ◽  
Superiority Trial

AbstractThe study, a two-arm, randomized controlled, parallel group, superiority trial, aimed to evaluate the implementation and effectiveness of a 12-month one-to-one volunteer mentoring program designed to improve behavioral and emotional outcomes in children aged 5 to 11 years who have teacher- and parent/carer-reported behavioral difficulties. Participants were 246 children (123 intervention, 123 control; mean age 8.4 years; 87% boys) in five sites in London, UK, scoring in the “abnormal” range on the teacher-rated Strengths and Difficulties Questionnaire (SDQ) Total Difficulties measure and in the “borderline” or abnormal range on the parent-rated SDQ Total Difficulties measure. Randomization on a 1:1 ratio took place using a computer-generated sequence and stratifying by site. Data collectors and statisticians were blind to participant allocation status. Outcome measures focused on parent- and teacher-rated child behavior and emotions, and child-rated self-perception and hope. Intention-to-treat analysis on all 246 randomized participants (using imputed data where necessary) showed that at post-intervention (16 months after randomization), there were no statistically significant effects on the primary outcome—parent-rated SDQ Total Difficulties (adjusted standardized mean difference = − 0.12; 95% CI: −0.38 to 0.13; p = 0.33)—or any secondary outcomes. Results from complier average causal effect (CACE) analysis using the primary outcome indicated the intervention was not effective for children who received the recommended duration of mentoring. Exploratory analyses found no sub-group effects on the primary outcome. The article concludes that the mentoring program had no effect on children’s behavior or emotional well-being, and that program content needs revising to satisfactorily address key risk and protective factors.

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