scholarly journals Group Psychoeducational Intervention for Grandparents of Young Children with ASD: An Open Feasibility Study

2021 ◽  
Author(s):  
Rano Zakirova-Engstrand ◽  
Lise Roll-Pettersson ◽  
Kristina Andersson ◽  
Helena Larsson ◽  
Mara Allodi Westling ◽  
...  
Keyword(s):  
Intervention Program ◽  
Controlled Trial ◽  
Psychoeducational Intervention ◽  
Feasibility Trial ◽  
Post Intervention ◽  
Custodial Grandparents ◽  
Children With Asd ◽  
Intervention Measures ◽  
Intervention Acceptability

AbstractThis initial open feasibility trial reports on feasibility and preliminary effectiveness of the manualized, group-based psychoeducational intervention for grandparents of preschool-aged children with ASD provided by the outpatient habilitation services in Stockholm, Sweden. One hundred and twenty non-custodial grandparents participated in a 6-h intervention program. The study demonstrated good feasibility: 114 (95%) grandparents competed both pre- and post-intervention measures and evaluations and reported high intervention acceptability. The results also indicated that grandparents increased their knowledge about ASD from pre-intervention to post-intervention, gained skills about strategies of supporting their grandchildren and adult children, and appreciated the opportunity to meet and share experiences with other grandparents. Follow-up with a randomized controlled trial design is needed to firmly establish efficacy of this intervention.

A randomized trial to assess the efficacy of a psychoeducational intervention on caregiver burden in schizophrenia

2016 ◽  
Vol 33 (1) ◽  
pp. 9-17 ◽  
Author(s):  
M. Martín-Carrasco ◽  
P. Fernández-Catalina ◽  
A.I. Domínguez-Panchón ◽  
M. Gonçalves-Pereira ◽  
E. González-Fraile ◽  
...  
Keyword(s):  
Caregiver Burden ◽  
Standard Care ◽  
Intervention Program ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychoeducational Intervention ◽  
Negative Consequences ◽  
Post Intervention ◽  
Control Intervention

AbstractBackgroundPatient's relatives usually care for patients with schizophrenia, and as informal caregivers they experience negative consequences. The aim of the EDUCA-III trial is to test the efficacy of a psychoeducational intervention program (PIP) versus standard care to reduce the caregiver burden at post-intervention (4 months), and at follow-up (8 months).MethodA two-arm, evaluator blind, multicentre, randomized controlled trial. The PIP group had 12 weekly group sessions. The control intervention group had the usual support and standard care. Primary outcomes were change scores since baseline on the Zarit Burden Interview (ZBI) and the Involvement Evaluation Questionnaire (IEQ).ResultsOne hundred and nine caregivers were randomized to PIP and 114 to control condition from 23 research sites. The decrease of ZBI scores was significantly higher on the PIP arm at 4 months (mean difference [MD] = −4.33; 95% CI −7.96, −0.71), and at 8 months (MD = −4.46; 95% CI −7.79, −1.13). There were no significant decreases in the IEQ scores (MD at 4 months = −2.80; 95% CI −6.27, 0.67; MD at 8 months = −2.85; 95% CI −6.51, 0.81).ConclusionsThe PIP condition seems to reduce caregiver burden.Trial registrationISRCTN32545295.

scholarly journals Protocol for the Work Engagement and Well-being Study (SWELL): A randomised controlled feasibility trial evaluating the effects of mindfulness versus light physical exercise at work

2021 ◽  
Author(s):  
Maris Vainre ◽  
Julieta Galante ◽  
Peter Watson ◽  
Tim Dalgleish ◽  
Caitlin Hitchcock
Keyword(s):  
Physical Exercise ◽  
Work Performance ◽  
Controlled Trial ◽  
Well Being ◽  
Performance Outcomes ◽  
Feasibility Trial ◽  
Post Intervention ◽  
Randomised Controlled ◽  
Preventative Interventions

Mental ill health is a major cause of disability. Workplaces are attractive for preventative interventions since most adults work while employers are interested in improving employees’ well-being and productivity. Mindfulness-based programmes are increasingly in occupational settings. However, there is inconsistent evidence whether mindfulness interventions improve work performance and how effective mindfulness-based programmes are, compared to other interventions, in preventing mental ill health.In this online randomised controlled feasibility trial, an anticipated 240 employees will be randomised to either a 4-week light physical exercise course or a mindfulness course of the same duration (1:1 allocation). The primary outcome is work performance, measured using the Work Role Functioning Questionnaire. We aim to evaluate the acceptability, feasibility, and procedural uncertainties of a randomised controlled trial in a workplace, calculate an effect size estimate to inform power calculations for a larger trial, and explore whether improved executive function and/or enhanced mental health could be potential mechanisms underlying the effect of mindfulness on work performance. Outcomes will be collected at baseline, post-intervention and 12-week follow-up.

scholarly journals 71 Ultrasound directed reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomized controlled trial

2020 ◽  
Vol 37 (12) ◽  
pp. 835.3-836
Author(s):  
Hamza Malik ◽  
Andrew Appelboam ◽  
Gordon Taylor ◽  
Daryl Wood ◽  
Karen Knapp
Keyword(s):  
Data Collection ◽  
Controlled Trial ◽  
Wrist Fracture ◽  
Recruitment Rate ◽  
Feasibility Trial ◽  
Point Of Care Ultrasound ◽  
Distal Radial Fractures ◽  
Definitive Trial ◽  
Randomised Controlled

Aims/Objectives/BackgroundWrist fractures are among the commonest injuries seen in the emergency department (ED). Around 25% of these injuries have Colles’ type fracture displacement and undergo manipulation in the ED. In the UK, these manipulations are typically done ‘blind’ without real time imaging and recent observational studies show that over 40% of the injuries go on to require surgical fixation (due to inadequate initial reduction or re-displacement). Point of care ultrasound has been used to guide and improve wrist fracture reductions but it’s effect on subsequent outcome is not established. We set up and ran the UK’s first randomised controlled feasibility trial comparing standard and ultrasound guided ED wrist fracture manipulations to test a definitive trial protocol, data collection and estimate recruitment rate towards a future definitive trial.Methods/DesignWe conducted a 1:1, single blind, parallel group, randomised controlled feasibility trial in two UK hospitals. Adults with Colles’ type distal radial fractures requiring manipulation in the ED were recruited by supervising emergency physicians supported by network research nurses. Participants were randomised to ultrasound directed fracture manipulation (intervention) or standard care with sham ultrasound (controls). The trial was run through Exeter Clinical Trials Unit and consent, randomisation and data collection conducted electronically in REDCap cloud. All participants were followed up at 6 weeks to record any surgical intervention and also underwent baseline and 3 month quality of life (EQ-5D-5L) and wrist function (Patient Rated Wrist Evaluation (PRWE) assessments.Results/ConclusionsWe recruited 47 patients in total, with 23 randomised to the interventional arm and 24 randomised to the control arm. We were able to follow up 100% of the patients for the 6 week follow up. Data analysis and results will be presented at the time of the conference.

scholarly journals Pivotal Response Treatment with and without robot-assistance for children with autism: a randomized controlled trial

2021 ◽  
Author(s):  
Iris van den Berk-Smeekens ◽  
Manon W. P. de Korte ◽  
Martine van Dongen-Boomsma ◽  
Iris J. Oosterling ◽  
Jenny C. den Boer ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Children With Autism ◽  
Autism Spectrum ◽  
Pivotal Response Treatment ◽  
Robot Assisted ◽  
Randomized Controlled ◽  
Children With Asd ◽  
Robot Assistance

AbstractPivotal response treatment (PRT) is a promising intervention focused on improving social communication skills in children with autism spectrum disorder (ASD). Since robots potentially appeal to children with ASD and may contribute to their motivation for social interaction, this exploratory randomized controlled trial (RCT) was conducted comparing PRT (PRT and robot-assisted PRT) with treatment-as-usual (TAU). Seventy-three children (PRT: n = 25; PRT + robot: n = 25; TAU: n = 23) with ASD, aged 3–8 years were assessed at baseline, after 10 and 20 weeks of intervention, and at 3-month follow-up. There were no significant group differences on parent- and teacher-rated general social-communicative skills and blindly rated global functioning directly after treatment. However, at follow-up largest gains were observed in robot-assisted PRT compared to other groups. These results suggest that robot-assistance may contribute to intervention efficacy for children with ASD when using game scenarios for robot-child interaction during multiple sessions combined with motivational components of PRT. This trial is registered at https://www.trialregister.nl/trial/4487; NL4487/NTR4712 (2014-08-01).

scholarly journals A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 910
Author(s):  
Dorthe Djernis ◽  
Mia S. O’Toole ◽  
Lone O. Fjorback ◽  
Helle Svenningsen ◽  
Mimi Y. Mehlsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Self Compassion ◽  
Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

scholarly journals A novel brief treatment for methamphetamine use disorders in South Africa: a randomised feasibility trial

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
K. Sorsdahl ◽  
D. J. Stein ◽  
S. Pasche ◽  
Y. Jacobs ◽  
R. Kader ◽  
...  
Keyword(s):  
South Africa ◽  
Controlled Trial ◽  
Adverse Outcomes ◽  
Feasibility Trial ◽  
Control Group ◽  
Brief Treatment ◽  
Middle Income ◽  
Methamphetamine Use ◽  
Intention To Treat

Abstract Background Effective brief treatments for methamphetamine use disorders (MAUD) are urgently needed to complement longer more intensive treatments in low and middle income countries, including South Africa. To address this gap, the purpose of this randomised feasibility trial was to determine the feasibility of delivering a six-session blended imaginal desensitisation, plus motivational interviewing (IDMI) intervention for adults with a MAUD. Methods We enrolled 60 adults with a MAUD and randomly assigned them 1:1 to the IDMI intervention delivered by clinical psychologists and a control group who we referred to usual care. Feasibility measures, such as rates of recruitment, consent to participate in the trial and retention, were calculated. Follow-up interviews were conducted at 6 weeks and 3 months post-enrollment. Results Over 9 months, 278 potential particiants initiated contact. Following initial screening 78 (28%) met inclusion criteria, and 60 (77%) were randomised. Thirteen of the 30 participants assigned to the treatment group completed the intervention. Both psychologists were highly adherent to the intervention, obtaining a fidelity rating of 91%. In total, 39 (65%) participants completed the 6-week follow-up and 40 (67%) completed the 3-month follow-up. The intervention shows potential effectiveness in the intention-to-treat analysis where frequency of methamphetamine use was significantly lower in the treatment than in the control group at both the 6 week and 3-month endpoints. No adverse outcomes were reported. Conclusions This feasibility trial suggests that the locally adapted IDMI intervention is an acceptable and safe intervention as a brief treatment for MAUD in South Africa. Modifications to the study design should be considered in a fully powered, definitive controlled trial to assess this potentially effective intervention. Trial registration The trial is registered with the Pan African Clinical Trials Registry (Trial ID: PACTR201310000589295)

scholarly journals A randomised controlled trial to investigate the effectiveness of sustained photoprotective behaviour in xeroderma pigmentosum after intervention

BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S287-S287
Author(s):  
Tamara Searle ◽  
Jessica Walburn ◽  
Sam Norton
Keyword(s):  
Randomised Controlled Trial ◽  
Self Efficacy ◽  
Xeroderma Pigmentosum ◽  
Controlled Trial ◽  
Premalignant Lesions ◽  
Mental Wellbeing ◽  
Group Effect ◽  
Post Intervention ◽  
Randomised Controlled

AimsThis study aimed to investigate whether an intervention designed to improve photoprotective behaviours is effective at changing behaviour and whether any change could be maintained.BackgroundXeroderma Pigmentosum (XP) is a rare condition in which patients are at risk of malignancies when exposed to ultra-violet radiation (UVR). Sufferers must take extra precautions to protect themselves from UVR. They must apply sunscreen to exposed skin, wear thick clothing, gloves, and a UVR-protective visor. Treatments include preventative photoprotective measures; the use of sunscreen and protective clothing. Additionally, frequent eye and skin examinations are required and swift removal of any premalignant lesions.MethodIn this randomised controlled trial, 16 participants with XP were given questionnaires at 4 time points; baseline, post-intervention, 5 months and 9 months post-intervention. The intervention involved 7 one-on-one counselling sessions, as well as telephone consultations. Counselling sessions encouraged photoprotection adherence, self-efficacy and discussions of any barriers to improving photoprotective behaviour. This study focused on psychosocial variables, attitudes and photoprotection. Questionnaires included the photoprotection self-efficacy questionnaire, Self-Reported Behavioural Automaticity Index, Short Warwick-Edinburgh Mental Wellbeing Scale, Quality of Life and Brief Photoprotection Adherence Questionnaire.ResultThe intervention was shown to have no significant effect on participants’ questionnaires scores. Univariate ANCOVA revealed a group effect between follow-up 1 (FU1) and follow-up 2 (FU2); η2 = 0.422 for self-efficacy in wearing photoprotective clothing. A group effect was identified from BL to FU1 and FU1 to FU2; η2 = 0.343 and η2 = 0.378 respectively in how often participants reapplied sunscreen to their face when outside for longer periods. Univariate ANCOVA revealed no group or time effect for the other outcome variables; for example, sunscreen self-efficacy.ConclusionThe intervention had no significant effect on photoprotective behaviour questionnaire scores. Future research could focus on recruiting more participants globally to generate more statistically powered results. Research should focus on producing a maintainable intervention so that any positive change would produce better long-term health outcomes. This study lays the foundations for future XP research, which will be vital to improve understanding and enhance photo protective behaviour.

Effect of psychoeducation website named “Imacoco-care” on improving psychological distress among workers under COVID-19 pandemic: a randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Kotaro Imamura ◽  
Natsu Sasaki ◽  
Yuki Sekiya ◽  
Kazuhiro Watanabe ◽  
Asuka Sakuraya ◽  
...  
Keyword(s):  
Mental Health ◽  
Adverse Effect ◽  
Psychological Distress ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychoeducational Intervention ◽  
Favorable Effect ◽  
Randomized Controlled ◽  
Small Effect Size

BACKGROUND The prolonged coronavirus disease 2019 (COVID-19) pandemic affected mental health among workers. Psychoeducational intervention via an Internet website could be effective for primary prevention of mental health among workers in the current COVID-19 pandemic. OBJECTIVE The aim of this randomized controlled trial (RCT) was to examine the effect of a newly developed online psychoeducational website named "Imacoco-care" on reducing psychological distress and fear about COVID-19 infection among workers. METHODS Participants in the present study were recruited from registered members of a web survey company in Japan. Participants who fulfilled the eligibility criteria were randomly allocated to intervention or control groups. Participants in the intervention group were invited to access the Imacoco-care within a month after the baseline survey. Kessler’s Psychological Distress Scale (K6) and The Fear of COVID-19 Scale (FCV-19S) were obtained at baseline, 1-, and 3-month follow-ups. RESULTS A total of 1200 workers were randomly allocated to an intervention or control group (n = 600 for each). In the intention-to-treat (ITT) analyses, the Imacoco-care showed significant favorable effect on K6 (p = 0.03) with small effect size (d = -0.14), and adverse effect on FCV-19S (p = 0.01) with small effect size (d = 0.16) in the intervention group at 3-month follow-up. In the per-protocol analyses (only included participants who have read the Imacoco-care at least one time), the Imacoco-care also showed significant favorable effect on reducing K6 (p = 0.03), while adverse effect on FCV-19S was not significant (p = 0.06) in the intervention group at 3-month follow-up. CONCLUSIONS A web-based psychoeducation approach may be effective on improving psychological distress in a general working population, while it may be important not only distributing information but also encouraging to access and see the contents to prevent the adverse effect of psychoeducational intervention. CLINICALTRIAL The University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). The registration number is UMIN000042556 (https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048548).

scholarly journals Sensorimotor vs. Motor Upper Limb Therapy for Patients With Motor and Somatosensory Deficits: A Randomized Controlled Trial in the Early Rehabilitation Phase After Stroke

2020 ◽  
Vol 11 ◽  
Author(s):  
Nele De Bruyn ◽  
Leen Saenen ◽  
Liselot Thijs ◽  
Annick Van Gils ◽  
Eva Ceulemans ◽  
...  
Keyword(s):  
Upper Limb ◽  
Controlled Trial ◽  
Motor Impairment ◽  
Early Rehabilitation ◽  
Stroke Patients ◽  
Post Intervention ◽  
Clinical Trial Registration ◽  
Additional Therapy ◽  
Somatosensory Function

Background: Somatosensory function plays an important role in motor learning. More than half of the stroke patients have somatosensory impairments in the upper limb, which could hamper recovery.Question: Is sensorimotor upper limb (UL) therapy of more benefit for motor and somatosensory outcome than motor therapy?Design: Randomized assessor- blinded multicenter controlled trial with block randomization stratified for neglect, severity of motor impairment, and type of stroke.Participants: 40 first-ever stroke patients with UL sensorimotor impairments admitted to the rehabilitation center.Intervention: Both groups received 16 h of additional therapy over 4 weeks consisting of sensorimotor (N = 22) or motor (N = 18) UL therapy.Outcome measures: Action Research Arm test (ARAT) as primary outcome, and other motor and somatosensory measures were assessed at baseline, post-intervention and after 4 weeks follow-up.Results: No significant between-group differences were found for change scores in ARAT or any somatosensory measure between the three time points. For UL impairment (Fugl-Meyer assessment), a significant greater improvement was found for the motor group compared to the sensorimotor group from baseline to post-intervention [mean (SD) improvement 14.65 (2.19) vs. 5.99 (2.06); p = 0.01] and from baseline to follow-up [17.38 (2.37) vs. 6.75 (2.29); p = 0.003].Conclusion: UL motor therapy may improve motor impairment more than UL sensorimotor therapy in patients with sensorimotor impairments in the early rehabilitation phase post stroke. For these patients, integrated sensorimotor therapy may not improve somatosensory function and may be less effective for motor recovery.Clinical Trial Registration:www.ClinicalTrials.gov, identifier NCT03236376.

scholarly journals Robot-assisted gait training to reduce pusher behavior

Neurology ◽  
2018 ◽  
Vol 91 (14) ◽  
pp. e1319-e1327 ◽  
Author(s):  
Jeannine Bergmann ◽  
Carmen Krewer ◽  
Klaus Jahn ◽  
Friedemann Müller
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Gait Training ◽  
Class Ii ◽  
Control Group ◽  
Robot Assisted ◽  
Post Intervention ◽  
Subacute Stroke ◽  
Post Test

ObjectiveTo determine the effects of 2 weeks of intensive robot-assisted gait training (RAGT) on pusher behavior compared to nonrobotic physiotherapy (nR-PT).MethodsIn a single-blind, randomized, controlled trial with 2 parallel arms, we compared 2 weeks of daily RAGT (intervention group) with the same amount of nR-PT (control group). Patients with subacute stroke who had pusher behavior according to the Scale for Contraversive Pushing (SCP) were included. The primary research questions were whether changes in pusher behavior would differ between groups post intervention, and at a follow-up 2 weeks afterward (SCP and Burke Lateropulsion Scale, Class II evidence). Secondary outcomes included the Performance-Oriented Mobility Assessment, the Functional Ambulation Classification, and the Subjective Visual Vertical.ResultsThirty-eight patients were randomized. Thereof, 30 patients received the allocated intervention and were included in the analyses. RAGT led to a larger reduction of pusher behavior than nR-PT at post test (SCP: U = 69.00, r = −0.33, p = 0.037; Burke Lateropulsion Scale: U = 47.500, r = −0.50, p = 0.003) and at follow-up (SCP: U = 54.00, r = −0.44, p = 0.008). Pusher behavior had ceased in 6 of 15 participants in the intervention group and 1 of 15 participants in the control group at post test. At follow-up, 9 of 15 and 5 of 15 participants, respectively, no longer exhibited the behavior.ConclusionsTwo weeks of RAGT seems to persistently reduce pusher behavior, possibly by recalibrating the disturbed inner reference of verticality. The potential benefits of RAGT on pusher behavior and verticality perception require further investigation.Trial registrationGerman Clinical Trials Register (registration number: DRKS00003444).Classification of evidenceThis study provides Class II evidence that RAGT is beneficial to reduce pusher behavior in patients with stroke.

Sign in / Sign up

Export Citation Format

Share Document