scholarly journals Video Intervention Therapy for primary caregivers in a child psychiatry unit: a randomized feasibility trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fanny Leyton ◽  
Marcia Olhaberry ◽  
Javier Morán ◽  
Cecilia De la Cerda ◽  
María José León ◽  
...  
Keyword(s):  
Child Psychiatry ◽  
Randomized Control Trial ◽  
Primary Caregivers ◽  
Well Being ◽  
Feasibility Trial ◽  
Sufficient Evidence ◽  
Group Setting ◽  
Video Intervention ◽  
Link Type ◽  
Randomized Control

Abstract Background During child psychiatry hospitalization, working with the families or attachment figures is a challenge, most of the children who are admitted to these units come from multi-problem families, with limited research in this area. Video feedback (VF) interventions have proved to be a powerful resource to promote parental and child well-being in small children and has been used with parents with a psychiatric condition. Parental Reflective Functioning (PRF) is one of the parental abilities that can be improved with VF and could be especially important in coping with conflict and negative emotions in older children. The aim of this study is to implement Video Intervention Therapy (VIT) to enhance PRF in primary caregivers of inpatient psychiatric children. As there is no published research using VF with parents of children with severe psychopathology in a hospitalized context. This report, then, becomes a much needed pilot study providing evidence for a larger randomized control trial (RCT). Methods The study is a single-center, two-arm feasibility randomized control trial with a qualitative component. Block randomization was done to generate a 2:1 allocation, leaving more participants in the intervention group. The intervention comprises four modules; every module has both one video-recorded play session and one VIT session (in a group setting) per week. Evaluation of the caregivers included assessments of PRF and well-being, and child assessment included parent-ratings and clinician-ratings of symptomatology and general functioning. Results Thirty participants were randomized; eligibility and recruitment rate were 70.6% and 83.3%, respectively. The compliance-to-intervention rate was 85% in the VIT group and 90% in the control group. All participants completed entry evaluation and 90% at the 3-month follow-up. The intervention was acceptable to participants and feasible for therapists to deliver. Outcome data must be treated with caution due to the small numbers involved, yet indicate that the VIT may have a positive effect in improving parental and child mental health outcomes. Conclusions VIT for primary caregivers of child inpatient children was feasible to deliver and acceptable for participants, therapist, and the staff unit involved; there is sufficient evidence to undertake a full-scale effectiveness RCT. Trial registration ClinicalTrials.govNCT03374904. Registered on 14 December 2017

scholarly journals Video Intervention Therapy for Primary Caregivers in a Child Psychiatry Unit: A Randomized Feasibility Trial

2021 ◽  
Author(s):  
Fanny Leyton ◽  
Marcia Olhaberry ◽  
Javier Morán ◽  
Cecilia de la Cerda ◽  
María José León ◽  
...  
Keyword(s):  
Child Psychiatry ◽  
Randomized Control Trial ◽  
Primary Caregivers ◽  
Feasibility Trial ◽  
Sufficient Evidence ◽  
Control Group ◽  
Child Assessment ◽  
Group Setting ◽  
Video Intervention ◽  
Randomized Control

Abstract Background: During child psychiatry hospitalization, working with the families or attachment figures is a challenge, most of the children who are admitted to these units come from multi-problem families, with limited research in this area. Video Feedback (VF) intervention have proved to be a powerful resource to promote parental and child wellbeing in small children and has been used with parents with a psychiatric condition. Parental Reflective Functioning (PRF) is one of the parental abilities that can be improved with VF and could be especially important in coping with conflict and negative emotions in older children. The aim of this study is to implement Video Intervention Therapy (VIT) to enhance PRF in primary caregivers of inpatient psychiatric children. As there is no published research using VF with parents of children with severe psychopathology in a hospitalized context, this becomes a much needed pilot study providing evidence for a larger randomized control trial (RCT). Methods: The study is a single center, two-arm feasibility randomized control trial with a qualitative component. Block randomization was done to generate a 2:1 allocation, leaving more participants in the intervention group. The intervention comprises four modules; every module has both one video-recorded play session and one VIT session (in a group setting) per week. Evaluation of the caregivers included assessments of PRF and wellbeing, child assessment included parent-ratings and clinician-ratings of symptomatology and general functioning. Results: Thirty participants were randomized; eligibility and recruitment rate were 70.6% and 83.3% respectively. Compliance-to-intervention rate was 85% in the VIT group and 90% in the control group. All participants completed entry evaluation and 90% at 3 months follow-up. The intervention was acceptable to participants and feasible for therapists to deliver. Outcome data must be treated with caution due to the small numbers involved, yet indicate that the VIT may have a positive effect in improving parental and child mental health outcomes.Conclusions: VIT for primary caregivers of child inpatient children was feasible to deliver and acceptable for participants, therapist and the staff unit involved, there is sufficient evidence to undertake a full-scale effectiveness RCT.Trial registration: ClinicalTrials.gov, NCT03374904. Registered on 14 December 2017

scholarly journals Tele-Assisted Behavioral Intervention for Families with Children with Autism Spectrum Disorders: A Randomized Control Trial

2020 ◽  
Vol 10 (9) ◽  
pp. 649
Author(s):  
Flavia Marino ◽  
Paola Chilà ◽  
Chiara Failla ◽  
Ilaria Crimi ◽  
Roberta Minutoli ◽  
...  
Keyword(s):  
Behavioral Intervention ◽  
Randomized Control Trial ◽  
Controlled Trial ◽  
Children With Autism ◽  
Autism Spectrum ◽  
Group Setting ◽  
Children's Behavior ◽  
Intervention Protocol ◽  
Randomized Control ◽  
Families With Children

Background: Telehealth is useful for both autism spectrum disorder (ASD) diagnosis and treatment, but studies with a direct comparison between teletherapy and traditional in-person therapy are limited. Methods: This randomized control trial—ISRCTN (International Standard Randomised Controlled Trial Number) primary clinical trial registry ID ISRCTN15312724—was aimed at comparing the effect of a tele-assisted and in-person intervention based on a behavioral intervention protocol for families with children affected by ASDs. Forty-two parents with children with autism (30 months to 10 years old) were randomly assigned to 12 sessions of an applied behavioral analysis (ABA) intervention implemented in an individual and group setting, either with or without the inclusion of tele-assistance. Pre- and postintervention assessments were conducted using the Home Situation Questionnaire (HSQ-ASD) and the Parental Stress Index (PSI/SF). Results: Substantial improvements in the perception and management of children’s behavior by parents, as well as in the influence of a reduction in parent stress levels on said children’s behavior through the use of a tele-assisted intervention, were obtained. Conclusions: This randomized controlled trial demonstrates the evidence-based potential for telehealth to improve treatment of ASDs.

scholarly journals 73 The Use of Topical Anaesthetic in The Banding of Internal Haemorrhoids: A Feasibility Study for A Randomized Control Trial

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
V Sharma ◽  
D Sharma ◽  
A Stearns ◽  
J Hernon
Keyword(s):  
Outcome Measures ◽  
Randomized Control Trial ◽  
Recruitment Rate ◽  
Phase Iii ◽  
Feasibility Trial ◽  
Secondary Outcome ◽  
Topical Anaesthetic ◽  
Pain Scores ◽  
Significant Difference ◽  
Randomized Control

Abstract Aim Rubber band ligation (RBL) is a procedure commonly performed in colorectal clinics for internal haemorrhoids. 90% of patients experience pain following RBL. We aimed to complete a feasibility randomized control trial assessing the role of topical anaesthetic before RBL of internal haemorrhoids. Method We performed a prospective, single-centre, single blinded, randomized(1:1) controlled feasibility trial. Patients presenting with symptomatic haemorrhoids suitable for banding were randomized to undergo the procedure with local anaesthetic or without(control). Pain scores and vasovagal symptoms were assessed at 0 minutes, 30minutes, 4 hours, and 72 hours after the procedure. Primary outcome measures were recruitment rate, participant retention rate, patient and surgeon acceptability. Secondary outcome measures were pain scores up to 72 hours, vasovagal episodes, new use of analgesia, and adverse outcomes. Results 35 patients (18 topical anaesthetic, group A; 17 no anaesthetic gel, group B) were recruited. Mean recruitment rate was 11.7 participants per month. 33(94%) participants remained in the study until completion, with 2 patients lost to telephone follow-up. The treatment was acceptable for 35(97%) eligible patients. 1 patient declined enrolment. The treatment was acceptable to all surgeons (100%). There was a significant difference in median pain scores of -2(95% CI -4.0 to -1.0, p = 0.0006) at the 30-minute time point only. There was no significant difference in vasovagal symptoms(p = 0.10) or new analgesia use(p = 0.85). Conclusions In conclusion, we have shown that a phase III clinical trial is feasible. We have demonstrated excellent patient recruitment and retention as well as patient and surgeon acceptability.

scholarly journals Evaluation of Impact of Ethics of Yoga in the Psychological Health of College Students: A Randomized Control Trial

2021 ◽  
Vol 14 (12) ◽  
pp. 995-1005
Author(s):  
Wen Xu ◽  
◽  
Itagi R Kumar ◽  
Thaiyar M Srinivasan
Keyword(s):  
College Students ◽  
Psychological Health ◽  
Randomized Control Trial ◽  
Well Being ◽  
T Test ◽  
Ethical Principles ◽  
Control Group ◽  
Randomized Control ◽  
Group Comparisons

Background/Objectives: The foundational ethical principles of yoga have not been of focus and not widely known. This study was to evaluate the yoga ethics that could reduce the level of stress in college students. Methods/Statisticalanalysis :A randomized control trial was conducted. One hundred participants were randomly assigned to control group and experiment group with a duration of three months intervention and one month follow-up. The outcome measures of stress level were assessed through Bio-Well instrument. A parametric independent sample t-test for the between-group analyses and paired sample t-test for within-group analysis compared the means of two groups. Findings: There was a statistically significant reduction in the stress after the intervention (p<0.001) and follow up (p=0.035) between the group comparisons. The within-group comparisons showed high reduced in the level of stress after the intervention (p<0.001) and follow-up (p<0.01). Novelty: The current study provides preliminary evidence that the practice of ethical principles of Yama and Niyama effectively reduces the stress and may improve psychological health and well-being. Keywords: Yoga ethics; Yama; Niyama; Stress; Psychological wellbeing; BioWell

scholarly journals Effect of Meditation and Breathing Exercises on the Well-being of Patients with SARS-CoV-2 Infection under Institutional Isolation: A Randomized Control Trial

2021 ◽  
Vol 0 ◽  
pp. 1-5
Author(s):  
Kiran Mahendru ◽  
Anuja Pandit ◽  
Vishwajeet Singh ◽  
Nandan Choudhary ◽  
Anant Mohan ◽  
...  
Keyword(s):  
Randomized Control Trial ◽  
Well Being ◽  
Control Group ◽  
Quality Of Sleep ◽  
Positive Effects ◽  
Breathing Exercises ◽  
Falling Asleep ◽  
Stress Levels ◽  
Randomized Control

Objectives: The corona virus disease-19 (COVID-19) pandemic has affected every domain of human health be it physical or mental. The uncertainty of disease progression in patients with SARS-CoV-2 infection can lead to major psychological and psychiatric concerns that should not be overlooked. The interventions should be directed to the vulnerable population to help them mitigate the stress and anxiety caused by the infection and isolation. We evaluated the effect of meditation and breathing exercises on the well-being of patients with SARS-CoV-2 infection under institutional isolation. Materials and Methods: We conducted a randomized control trial on 84 subjects, 18 years and above, asymptomatic, or mildly symptomatic SARS-CoV-2 infected patients under institutional isolation. Subjects were randomly and equally divided into a control group and interventional group. We measured the depression, anxiety, and stress levels as well as quality of sleep in patients after 7 days of meditation and breathing exercises in the intervention group versus standard care in the control group. Results: Mediation and breathing exercises had a statistically significant effect on the depression level (P < 0.001), stress level (P = 0.004), and the quality of sleep [trouble falling asleep (P = 0.007), trouble staying asleep (P = 0.004), and feel tired after waking up in the morning (P = 0.003)]. Further, the positive effect of intervention on the level of anxiety in patients under isolation was also observed; however, the difference was not found to be statistically significant (P = 0.528). Conclusion: Meditation and breathing exercises have positive effects on depression, stress levels, and quality of sleep in COVID-19 positive patients under strict institutional isolation.

Randomizing Development

2020 ◽  
pp. 79-107
Author(s):  
Lant Pritchett
Keyword(s):  
Randomized Control Trial ◽  
National Development ◽  
Well Being ◽  
Important Argument ◽  
Social Treatment ◽  
Randomized Control ◽  
Cross National ◽  
Effective Programs

An important argument for the increased use of randomized control trial methods in development is that the evidence from these studies will encourage the uptake of effective programs and projects (both through discouraging ineffective projects and improving design of new projects) and this will lead to reduced poverty and improved human well-being. However, cross-national evidence shows that the four-fold transformation of national development, to higher productivity economies, to more responsive states, the more capable organizations and administration and to more equal social treatment produces gains in poverty and human well-being that are orders of magnitude bigger than the best that can be hoped from better programs. Arguments that RCT research is a good (much less “best”) investment depend on both believing in an implausibly low likelihood that non-RCT research can improve progress national development and believing in an implausibly large likelihood that RCT evidence improves outcomes.

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