The Effect of a Structured Intervention to Improve Motor Skills in Preschool Children: Results of a Randomized Controlled Trial Nested in a Cohort Study of Danish Preschool Children, the MiPS Study

The preschool age seems to be decisive for the development of motor skills and probably the most promising time-window in relation to improvement of motor skills. This trial investigates the effect of an intensive structured intervention to improve motor skills in 3–6-year-old preschool children. A total of 471 Danish preschool children participated in a cluster randomized controlled trial. The intervention was to enhance motor skills, including predefined minimum criteria. Motor skills were measured using the Motor Assessment Battery for Children-2 (MABC-2) (total and three domains) at baseline and 6-, 18-, and 30-months post-intervention. The effect was estimated by multilevel linear regression with preschool and child included as random effects and adjusted for baseline values. Effect estimates were mainly positive at 6 months, but negative at 30 months with very few statistically significant estimates. In preschools with baseline motor skills scores below average, there was a tendency towards a larger improvement in the intervention group. Future interventions and research should focus on clusters with poor motor skills, as there is larger room for improvement. It remains to be seen whether the intervention can influence general well-being, physical activity, and self-perceived competence, both short- and long-term.

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A randomized controlled trial of a specific reminiscence approach to promote the well-being of nursing home residents with dementia

International Psychogeriatrics ◽

10.1017/s1041610204000055 ◽

2004 ◽

Vol 16 (1) ◽

pp. 33-49 ◽

Cited By ~ 80

Author(s):

Claudia K. Y. Lai ◽

Iris Chi ◽

Jeanie Kayser-Jones

Keyword(s):

Randomized Controlled Trial ◽

Nursing Home ◽

Repeated Measures ◽

Comparison Group ◽

Controlled Trial ◽

Intervention Group ◽

Nursing Home Residents ◽

Well Being ◽

Control Group ◽

Randomized Controlled

Background: To date, no firm conclusions can be reached regarding the effectiveness of reminiscence for dementia. Researchers have emphasized that there is an urgent need for more systematic research in the area.Objective and Method: A single-blinded, parallel-groups (one intervention, one comparison, and one no-intervention group) randomized controlled trial (RCT) was adopted to investigate whether a specific reminiscence program leads to higher levels of psychosocial well-being in nursing home residents with dementia. The intervention adopted a life-story approach, while the comparison group provided friendly discussions to control for any changes in outcome as a result of social contacts and attention. The Social Engagement Scale (SES) and Well-being/Ill-being Scale (WIB) were the outcome measures used. The outcomes of the groups were examined with reference to the baseline (T0), immediately (T1), and six weeks (T2) after intervention. The final sample had 101 subjects (control group: n=30; comparison group: n=35; intervention group: n=36). Using multivariate analysis with repeated measures, no significant differences in outcome were found between groups at either T1 or T2. Wilcoxon signed rank tests were performed for each group comparing outcomes between T1 and T0, T2 and T1, and T2 and T0. Significant differences were observed in the intervention group when comparing T1 and T0 WIB (p=.014), but not for the other groups.Conclusion: Although the intervention did not lead to significant differences between the three groups over time, there was a significant improvement in psychosocial well-being for the intervention group.

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Comparing The Effects of Self-Selected Music Versus Predetermined Music On Patient Anxiety Prior To Gynaecological Surgery: The MUANX Randomized Controlled Trial

10.21203/rs.3.rs-274561/v1 ◽

2021 ◽

Author(s):

Danielle Reynaud ◽

Nicolas Bouscaren ◽

Victorine Lenclume ◽

Malik Boukerrou

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Preoperative Anxiety ◽

Control Group ◽

Gynaecological Surgery ◽

Patient Anxiety ◽

Randomized Controlled ◽

Significant Difference

Abstract Background: Anxiety is frequently observed in the preoperative setting. The negative impact of preoperative anxiety is well known. In the context of gynaecological surgery, anxiety is exacerbated by the fact that the intervention can have catastrophic repercussions on a woman’s body image, sexuality, and psycho-affective well-being. Music listening is increasingly used as an alternative therapy for minimizing preoperative anxiety. Personal preferences, familiarity and popularity may be key elements for an optimal relaxation response to music. This study aimed to determine whether listening to self-selected music decreases preoperative anxiety in women scheduled to undergo gynaecologic surgery compared with predetermined music from an application (MUSIC CARE®).Methods: The MUANX study was a single-blind, monocentric, parallel, superiority, randomized controlled trial. A total of 174 women were included and randomized in two groups between August 2017 and September 2018. Patients in the intervention group listened to the personal music playlist that they had created before being hospitalized. Patients in the control group listened to the predetermined playlist on the MUSIC CARE® application. All patients received standard nursing care and listened to 20 minutes of music one hour before surgery. Anxiety scores were assessed before and after the music session using Spielberger’s State-Trait Anxiety Inventory (STAI).Results: The mean age of the 171 evaluated patients was 41.5 years (SD=10.0 years). Before the music session, the STAI state anxiety score was similar in the control group (M=38.8, SD=11.9) and the intervention group (M=39.0, SD=13.1). After the music session, this score had significantly decreased in both the control group (M= -7.2, SD=9.0) and the intervention group (M=-5.5, SD=6.6), with no significant difference in score reduction between groups. Physiological parameters were unchanged after the music session. No significant differences in postoperative measurements (pain intensity, hospitalization duration) were observed between the two groups.Conclusion: Self-selected music is as effective as predetermined music for reducing patient anxiety before gynaecological surgery. As it has no side effects and is easily applicable in gynaecological surgical services, this non-drug intervention may be proposed by healthcare professionals in the management of preoperative anxiety.Trial registration The MUANX trial is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT03226834. Registered on 24 July 2017. https://clinicaltrials.gov/ct2/show/NCT03226834?term=muanx&draw=2&rank=1

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Improvements in Health-Related Quality of Life, Cardio-Metabolic Health, and Fitness in Postmenopausal Women After an Exercise Plus Health Promotion Intervention: A Randomized Controlled Trial

Journal of Physical Activity and Health ◽

10.1123/jpah.2016-0218 ◽

2017 ◽

Vol 14 (5) ◽

pp. 336-343 ◽

Cited By ~ 8

Author(s):

Mercedes Vélez-Toral ◽

Débora Godoy-Izquierdo ◽

Nicolás Mendoza Ladrón de Guevara ◽

Carlos de Teresa Galván ◽

Alberto Salamanca Ballesteros ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Metabolic Health ◽

Metabolic Status ◽

Control Group ◽

Randomized Controlled ◽

Health And Fitness ◽

Mental Well Being

Background:This study explored multidimensional outcomes that were derived from the adherence to regular exercise among previously sedentary postmenopausal 45 to 64 years old women who engaged in a ~20-week exercise program.Methods:A randomized controlled trial with between-group (intervention and control women) and within-subject measures (baseline, postintervention, and 3-month and 12-month follow-ups) was conducted. HRQoL and several indicators of cardio-metabolic status and fitness were assessed.Results:After the intervention, the participants experienced a positive change in their short and long-term physical and mental health, with significant enhancements in several HRQoL dimensions, particularly mental well-being (23.3% of change) and menopause-related health and subdomains (17.0% of change) (P < .01). Improvements were maintained or continued (eg, mental well-being) overtime. These outcomes were accompanied by significant improvements in cardio-metabolic status and fitness, including weight, BMI, cardio-respiratory fitness and flexibility (up to 16.2% of change, P < .05). After the intervention, the intervention group exhibited better HRQoL than the control group at each of the measurement phases. Between-group differences were also observed for some indicators of cardiovascular health and flexibility.Conclusions:Our findings add evidence on the association of positive outcomes on HRQoL with improvements in cardio-metabolic health and fitness status after the adoption of an active lifestyle.

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Resilience, Insight, Self-Compassion, and Empowerment (RISE): A Randomized Controlled Trial of a Psychoeducational Group Program for Nurses

Journal of the American Psychiatric Nurses Association ◽

10.1177/10783903211033338 ◽

2021 ◽

pp. 107839032110333

Author(s):

Amanda T. Sawyer ◽

Amanda K. Bailey ◽

Jeanette F. Green ◽

Jingwei Sun ◽

Patricia Stearnes Robinson

Keyword(s):

Randomized Controlled Trial ◽

Perceived Stress ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Psychoeducational Group ◽

Randomized Controlled ◽

Self Compassion ◽

Mind Set

Background: Nurses tend to be vulnerable to burnout and compassion fatigue due to constant workplace stressors. There is a need to provide advocacy, education, programming, and resources in the areas of positive coping and self-care to reduce burnout symptoms and promote well-being. RISE is an 8-week psychoeducational group intervention for nurses with four themes: resilience, insight, self-compassion, and empowerment. Objectives: This randomized controlled trial examined the effects of RISE on mental well-being. Methods: The sample included 75 registered nurses who work in a hospital-based setting. Outcomes included resilience, insight, self-compassion, empowerment, stress mind-set, perceived stress, and burnout. Independent-samples t tests were conducted to compare outcomes between intervention and wait-list control groups at baseline and 1-month follow-up, as well as at 3-month follow-up. Supplemental analyses included paired-samples t tests and linear mixed models to compare the outcomes of the intervention group participants at baseline to 1-month follow-up, as well as at 3-month and 6-month follow-ups. Results: Participants in the intervention group showed improved levels of insight (i.e., engagement in self-reflection), perceived stress, and burnout (i.e., emotional exhaustion) when compared with the control group and improved levels of resilience, self-compassion, stress mind-set, and perceived stress when compared with their baseline. Conclusions: This study informs how RISE affects nurse well-being and may be an effective intervention for reducing burnout and stress. This type of whole-person intervention can support nurses to improve their well-being and ability to cope amid the complex interplay of factors at the individual, unit, and organizational levels.

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REMOTION Blended Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting: Protocol for a Pilot Randomized Controlled Trial (Preprint)

10.2196/preprints.20936 ◽

2020 ◽

Author(s):

Laura Luisa Bielinski ◽

Tobias Krieger ◽

Franz Moggi ◽

Leonie Trimpop ◽

Ulrike Willutzki ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Emotion Regulation ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Brief Symptom Inventory ◽

Randomized Controlled ◽

Blended Treatment ◽

Internet Based Intervention ◽

Pilot Randomized Controlled Trial

BACKGROUND Emotion regulation has been identified as an important transdiagnostic factor relevant to the treatment of mental health disorders. Many empirically validated psychotherapeutic treatments incorporate elements targeting emotion regulation. Most of these treatment approaches are conceptualized as standard face-to-face treatments not as blended treatments, which include an internet-based intervention. OBJECTIVE The aim of this study is to examine, for the first time, a new internet-based intervention—REMOTION—that will be provided transdiagnostically, as an add-on to psychotherapy, to provide a blended treatment format. METHODS A total of 70 participants will be assigned (1:1 allocation ratio) to either the intervention group (REMOTION + psychotherapy) or the treatment-as-usual group that receives psychotherapy alone. To maximize external validity, a typical outpatient treatment sample of patients diagnosed with a range of disorders such as depression, anxiety disorders, and adjustment disorder will be recruited from a university outpatient clinic. Patients with bipolar disorder, psychotic disorders, or acute suicidality will be excluded from the study. The feasibility and potential effectiveness of the intervention will be examined by assessing data at baseline, 6 weeks (post), and 12 weeks (follow-up). The primary outcome is general symptom severity, assessed with the Brief Symptom Inventory. Secondary outcomes are emotion regulation, depressive symptoms, anxiety symptoms, health related quality of life, well-being, and a variety of feasibility parameters. Quantitative data will be analyzed on an intention-to-treat basis. RESULTS Participant recruitment and data collection started in February 2020, and as of November 2020, are ongoing. Results for the study are expected in 2022. CONCLUSIONS This pilot randomized controlled trial will inform future studies using transdiagnostic blended treatment. CLINICALTRIAL ClinicalTrials.gov NCT04262726; http://clinicaltrials.gov/ct2/show/NCT04262726 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/20936

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Effects of Sharing Old Pictures With Grandchildren on Intergenerational Relationships: Protocol for a Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/16315 ◽

2020 ◽

Vol 9 (4) ◽

pp. e16315

Author(s):

Zoljargalan Gantumur ◽

Marcos Baez ◽

Nomin-Erdene Ulamnemekh ◽

Francisco Ibarra ◽

Sugarmaa Myagmarjav ◽

...

Keyword(s):

Older Adults ◽

Social Media ◽

Randomized Controlled Trial ◽

Identity Development ◽

Controlled Trial ◽

Intervention Group ◽

Intergenerational Relationships ◽

Well Being ◽

Lessons Learned ◽

Randomized Controlled

Background Intergenerational relationships are beneficial for both grandparents and grandchildren. A positive grandparent-grandchild relationship can improve the psychological well-being of older adults and be a source of social support, family history, and identity development. Maintaining meaningful interactions can be, however, a challenging endeavor, especially as life events lead to relocating geographically. Grandparents and grandchildren can have different preferences in terms of communication mediums and different assumptions about the real conversational needs of the other. Objective In this study, we will investigate the feasibility and effect of sharing memories of older adults with their grandchildren in social media. This intervention focuses on bringing snippets of the lives of the grandparents into the grandchildren’s social media feed and analyzing the potential effect on relational quality, relational investment, and conversational resources from the perspective of the grandchildren. Methods A randomized controlled trial will be used to measure the effectiveness of sharing family memories through social media on intergenerational relationships from the perspective of the grandchildren. The study will be implemented in Mongolia among 60 grandparent-grandchild pairs who will be assigned to either a control or intervention group. Pictures and stories will be collected during reminiscence sessions between the researchers and the grandparents before the intervention. During an intervention period of 2 months, grandchildren in the intervention group will receive pictures and stories of their grandparents on their social media account. Pre- and postintervention questionnaires will measure relationship quality, relationship investment, and conversational resources and will be used to assess the effectiveness of the intervention. Results We conducted a pretest pilot from January to April 2018 among 6 pairs of participants (6 grandparents and 6 grandchildren). The validation of the protocol was focused on the process, instruments, and technological setup. We continued the study after the validation, and 59 pairs of participants (59 grandparents and 59 grandchildren) have been recruited. The data collection was completed in November 2019. Conclusions The results of this study will contribute to strategies to stimulate social interactions in intergenerational pairs. A validation of the study process is also presented to provide further operational recommendations. The lessons learned during the validation of the protocol are discussed with recommendations and implications for the recruitment, reminiscence sessions, technological setup, and administration of instruments. International Registered Report Identifier (IRRID) DERR1-10.2196/16315

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The effect of the emotion regulation training on the resilience of caregivers of patients with schizophrenia: a parallel randomized controlled trial

BMC Psychology ◽

10.1186/s40359-021-00542-5 ◽

2021 ◽

Vol 9 (1) ◽

Author(s):

Maryam Behrouian ◽

Tahereh Ramezani ◽

Mahlagha Dehghan ◽

Abdoreza Sabahi ◽

Batool Ebrahimnejad Zarandi

Keyword(s):

Randomized Controlled Trial ◽

Emotion Regulation ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Control Group ◽

Psychological Traits ◽

Randomized Controlled ◽

Significant Difference ◽

The Mean

Abstract Background Schizophrenia is the most severe mental chronic disabling disease that the majority of the patients need constant care in a variety of aspects. Regarding the role of family caregivers in taking care of these patients, caregivers need to be resilient, in addition to other psychological traits, to adapt to the circumstance. This study aimed to investigate the effect of the emotion regulation training on the resilience of caregivers of patients with schizophrenia in southeastern Iran. Methods The study was a parallel randomized controlled trial. Seventy caregivers of patients with schizophrenia were selected by convenience sampling method and randomly assigned to an emotion regulation training group and a control group. The intervention group received eight 90-min training sessions (one session weekly) about emotion regulation. The participants completed the Conner–Davidson resilience scale before and one month after the intervention. Results The mean scores of the resilience increased in the control and intervention groups at the end of the study. A significant difference was found between the two groups (p < 0.001). At the beginning of the study, the mean score of the resilience was 59.94 in the control group and 51.97 in the intervention group. However, the mean score of the resilience in the control group was 61.28 after the intervention, which was not significant, but it was 69.08 in the intervention group, which was significant. A significant difference was observed between two groups in the mean scores (p = 0.01). Conclusions According to the results of this study, cognitive and metacognitive skills of emotion regulation can be suggested as one of the methods for increasing the psychological well-being of schizophrenia patients’ caregivers. The increase of mental well-being and resilience of caregivers can help them better manage a patient with schizophrenia. Trial registration IRCT registration number: IRCT2017061733997N2, Registration date: 2017-08-16, 1396/05/25, Registration timing: prospective, https://en.irct.ir/trial/26116

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BRAIN FITNESS INTERVENTION ON KNOWLEDGE AND WORRIES ABOUT ALZHEIMER’S: A RANDOMIZED CONTROLLED TRIAL

Innovation in Aging ◽

10.1093/geroni/igz038.000 ◽

2019 ◽

Vol 3 (Supplement_1) ◽

pp. S1-S1

Author(s):

Kaipeng Wang ◽

Fei Sun ◽

Qiuling An ◽

Yanfei Han ◽

Yi Zhou

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Treatment Group ◽

Tai Chi ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Control Group ◽

Randomized Controlled ◽

Brain Fitness

Abstract As one of the world’s fastest aging countries, China’s growing prevalence of Alzheimer’s and related dementias (ADRD) poses concerns among older adults. Lack of knowledge about ADRD and excessive worries about ADRD can cause cumulative stress and threaten physical and psychological well-being of older adults. We conducted a randomized controlled trial to examine the effectiveness of a Brain Fitness Intervention (BFI) on the knowledge and worries about Alzheimer’s at three senior residential care facilities in China. Ninety older adults aged 60 and above underwent randomization. Fifty participants in the intervention group received eight weekly BFI sessions, including Tai Chi exercise, experiential learning, and group discussions. The primary outcomes were the changes from baseline to Week 8 in the scores on the ADRD knowledge scale (ranging 5–50) and worry scale (ranging 5–45). Twenty-seven participants withdrew from the study. Intent-to-treat analysis showed that the estimated mean change in knowledge on ADRD was 4.26 in the treatment group and -1.52 in the control group (p < 0.001). The estimated mean change in worries about ADRD was -10.25 in the treatment group and -2.9 in the control group (p < 0.001). Results remained robust in sensitivity analysis adjusting for study sites and baseline characteristics. Heterogeneity analysis showed that the treatment effect became stronger with the increase of age. Findings support the effectiveness of BFI in increasing ADRD knowledge and reducing worries among Chinese older adults. Future trials with larger sample sizes will be needed for more conclusive results.

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REMOTION Blended Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting: Protocol for a Pilot Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/20936 ◽

2020 ◽

Vol 9 (11) ◽

pp. e20936

Author(s):

Laura Luisa Bielinski ◽

Tobias Krieger ◽

Franz Moggi ◽

Leonie Trimpop ◽

Ulrike Willutzki ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Emotion Regulation ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Brief Symptom Inventory ◽

Randomized Controlled ◽

Blended Treatment ◽

Internet Based Intervention ◽

Pilot Randomized Controlled Trial

Background Emotion regulation has been identified as an important transdiagnostic factor relevant to the treatment of mental health disorders. Many empirically validated psychotherapeutic treatments incorporate elements targeting emotion regulation. Most of these treatment approaches are conceptualized as standard face-to-face treatments not as blended treatments, which include an internet-based intervention. Objective The aim of this study is to examine, for the first time, a new internet-based intervention—REMOTION—that will be provided transdiagnostically, as an add-on to psychotherapy, to provide a blended treatment format. Methods A total of 70 participants will be assigned (1:1 allocation ratio) to either the intervention group (REMOTION + psychotherapy) or the treatment-as-usual group that receives psychotherapy alone. To maximize external validity, a typical outpatient treatment sample of patients diagnosed with a range of disorders such as depression, anxiety disorders, and adjustment disorder will be recruited from a university outpatient clinic. Patients with bipolar disorder, psychotic disorders, or acute suicidality will be excluded from the study. The feasibility and potential effectiveness of the intervention will be examined by assessing data at baseline, 6 weeks (post), and 12 weeks (follow-up). The primary outcome is general symptom severity, assessed with the Brief Symptom Inventory. Secondary outcomes are emotion regulation, depressive symptoms, anxiety symptoms, health related quality of life, well-being, and a variety of feasibility parameters. Quantitative data will be analyzed on an intention-to-treat basis. Results Participant recruitment and data collection started in February 2020, and as of November 2020, are ongoing. Results for the study are expected in 2022. Conclusions This pilot randomized controlled trial will inform future studies using transdiagnostic blended treatment. Trial Registration ClinicalTrials.gov NCT04262726; http://clinicaltrials.gov/ct2/show/NCT04262726 International Registered Report Identifier (IRRID) DERR1-10.2196/20936

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Effectiveness of Pediatric Teleconsultation to Improve Skin Conditions in Infants and to Reduce Parenting Stress in Mothers: Randomized Controlled Trial (Preprint)

10.2196/preprints.27615 ◽

2021 ◽

Author(s):

Tomohisa Ando ◽

Rintaro Mori ◽

Kenji Takehara ◽

Mari Asukata ◽

Shuichi Ito ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Atopic Dermatitis ◽

Parenting Stress ◽

Short Form ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Stress Index ◽

Control Group ◽

Randomized Controlled

BACKGROUND Electronic health (eHealth) for infants and mothers is a current focus of attention, but its effectiveness has rarely been examined in Japan. For infants, skin problems, including atopic dermatitis (AD), which is known to lead to other allergic diseases, is one of the most common conditions. For mothers, parenting stress, which adversely affects mothers’ and children’s well-being, is one of the biggest problems in the postpartum period; this requires a national solution in Japan. OBJECTIVE To evaluate the effectiveness of pediatric teleconsultation for preventing atopic dermatitis in infants and reducing parenting stress in mothers in Japan. METHODS The study was an open-label, randomized, parallel-armed controlled trial. In total, 318 pairs of infants and mothers in Yokohama City Sakae Ward in Japan were recruited when they submitted birth cards to the ward, received the explanation, and completed online informed consent on the website for this trial. Eligible pairs of infant and mother were randomly assigned to the intervention group (n=140) or the control group (n=138). Participants in both the intervention and control groups received routine postnatal care from the local government services. In addition, participants in the intervention group had the option to use combined pediatric services with teleconsultation and email newsletters without any charge from the date of registration until the infant was 4 months of age. Primary outcomes were (i) the prevalence of AD in infants diagnosed based on the United Kingdom Working Party’s criteria; and (ii) parenting stress and mental status in mothers, assessed using the Parenting Stress Index-Short Form (PSI-SF) and General Health Questionnaire-12 (GHQ-12). Data were collected via the ward office staff and researcher at the 4-month checkup. RESULTS The prevalence of AD in infants was significantly lower in the intervention group than in the control group at the 4-month checkup (20% vs. 33%, P=.03; relative risk ratio, 0.614 [95% confidence interval, 0.406 to 0.927]). No significant differences were observed in the PSI-SF and GHQ-12 scores between the two groups. CONCLUSIONS This is the first randomized controlled trial demonstrating that a combined pediatric service with teleconsultation and email newsletters was effective in reducing the prevalence of AD in infants. Pediatric eHealth will become a new strategy for preventing AD. CLINICALTRIAL UMIN000029774; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034022

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