scholarly journals WHO Parents Skills Training (PST) programme for children with developmental disorders and delays delivered by Family Volunteers in rural Pakistan: study protocol for effectiveness implementation hybrid cluster randomized controlled trial

2017 ◽  
Vol 4 ◽  
Author(s):  
S. U. Hamdani ◽  
P. Akhtar ◽  
Zill-e-Huma ◽  
H. Nazir ◽  
F. A. Minhas ◽  
...  
Keyword(s):  
Mental Health ◽  
Developmental Disorders ◽  
Controlled Trial ◽  
Public Mental Health ◽  
Skills Training ◽  
Well Being ◽  
Evidence Based ◽  
Post Intervention ◽  
Hybrid Cluster ◽  
Rural Pakistan

Background.Development disorders and delays are recognised as a public health priority and included in the WHO mental health gap action programme (mhGAP). Parents Skills Training (PST) is recommended as a key intervention for such conditions under the WHO mhGAP intervention guide. However, sustainable and scalable delivery of such evidence based interventions remains a challenge. This study aims to evaluate the effectiveness and scaled-up implementation of locally adapted WHO PST programme delivered by family volunteers in rural Pakistan.Methods.The study is a two arm single-blind effectiveness implementation-hybrid cluster randomised controlled trial. WHO PST programme will be delivered by ‘family volunteers’ to the caregivers of children with developmental disorders and delays in community-based settings. The intervention consists of the WHO PST along with the WHO mhGAP intervention for developmental disorders adapted for delivery using the android application on a tablet device. A total of 540 parent-child dyads will be recruited from 30 clusters. The primary outcome is child's functioning, measured by WHO Disability Assessment Schedule – child version (WHODAS-Child) at 6 months post intervention. Secondary outcomes include children's social communication and joint engagement with their caregiver, social emotional well-being, parental health related quality of life, family empowerment and stigmatizing experiences. Mixed method will be used to collect data on implementation outcomes. Trial has been retrospectively registered at ClinicalTrials.gov (NCT02792894).Discussion.This study addresses implementation challenges in the real world by incorporating evidence-based intervention strategies with social, technological and business innovations. If proven effective, the study will contribute to scaled-up implementation of evidence-based packages for public mental health in low resource settings.Trial registration.Registered with ClinicalTrials.gov as Family Networks (FaNs) for Children with Developmental Disorders and Delays. Identifier: NCT02792894 Registered on 6 July 2016.

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

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

Abstract Background Siblings and parents of children with neurodevelopmental disorders are at risk of mental health problems and poorer family communication. Some group interventions for siblings exist, but few have clearly described parent components and none are considered evidence-based. Methods We are conducting a randomized controlled trial comparing a five-session manual-based group intervention for siblings (aged 8 to 16 years) and parents of children with neurodevelopmental disorders to a 12-week waitlist, called SIBS-RCT. The intervention comprises three separate sibling and parent group sessions and two joint sessions in which each sibling talks to their parent alone. The intervention aims at improving parent-child communication and covers themes such as siblings’ understanding of the neurodevelopmental disorder, siblings’ emotions, and perceived family challenges. Participants are recruited through municipal and specialist health centers across Norway. The primary outcome is sibling mental health. Quality of life and family communication are secondary outcomes. Participants are block-randomized to the intervention or 12-week waitlist in groups of six. Measures are collected electronically at pre- and post-intervention/waitlist, as well as 3, 6, and 12 months post-intervention. The main effect to be examined is the difference between the intervention and waitlist at 12 weeks post. All outcomes will also be examined using growth curve analyses. We plan to include 288 siblings and their parents by the end of 2022. Discussion SIBS-RCT represents a major contribution to the research and practice field towards establishing an evidence-based intervention for siblings. In the event that intervention and waitlist are no different, the impact of SIBS-RCT is still substantial in that we will aim to identify participant subgroups that show positive response and effective components of the SIBS manual by examining group leader adherence as an outcome predictor. This will allow us to continue to re-engineer the SIBS manual iteratively to improve outcomes, and avoid the promotion of a less-than-optimal intervention. Trial registration ClinicalTrials.gov NCT04056884. Registered in August 2019

scholarly journals Online single-session interventions for Kenyan adolescents: study protocol for a comparative effectiveness randomised controlled trial

2021 ◽  
Vol 34 (3) ◽  
pp. e100446
Author(s):  
Akash R Wasil ◽  
Tom Lee Osborn ◽  
John R Weisz ◽  
Robert J DeRubeis
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Comparative Effectiveness ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Well Being ◽  
Single Session ◽  
Post Intervention ◽  
Digital Interventions ◽  
Randomised Controlled

BackgroundMental health problems are the leading cause of disability among adolescents worldwide, yet access to treatment is limited. Brief digital interventions have been shown to improve youth mental health, but little is known about which digital interventions are most effective.AimsTo evaluate the effectiveness of two digital single-session interventions (Shamiri-Digital and Digital-CBT (cognitive-behavioural therapy)) among Kenyan adolescents.MethodsWe will perform a school-based comparative effectiveness randomised controlled trial. Approximately 926 Kenyan adolescents will be randomly assigned to one of three conditions: Shamiri-Digital (focused on gratitude, growth mindsets and values), Digital-CBT (focused on behavioural activation, cognitive restructuring and problem solving) or a study-skills control condition (focused on note-taking and essay writing skills). The primary outcomes include depressive symptoms (measured by the Patient Health Questionnaire-8), anxiety symptoms (Generalized Anxiety Disorder Screener-7) and subjective well-being (Short Warwick-Edinburgh Mental Well-being Scale). The secondary outcomes include acceptability, appropriateness, primary control and secondary control. Acceptability and appropriateness will be measured immediately post-intervention; other outcomes will be measured 2 weeks, 4 weeks and 12 weeks post-intervention.ResultsWe hypothesise that adolescents assigned to Shamiri-Digital and adolescents assigned to Digital-CBT will experience greater improvements (assessed via hierarchical linear models) than those assigned to the control group. We will also compare Shamiri-Digital with Digital-CBT, although we do not have a preplanned hypothesis.ConclusionsOur findings will help us evaluate two digital single-session interventions with different theoretical foundations. If effective, such interventions could be disseminated to reduce the public health burden of common mental health problems.Trial registration numberPACTR202011691886690.

scholarly journals Harnessing single-session interventions to improve adolescent mental health and well-being in India: Development, adaptation, and pilot testing of online single-session interventions in Indian secondary schools

2019 ◽  
Author(s):  
Akash Wasil ◽  
Suh Jung Park ◽  
Sarah Gillespie ◽  
Rebecca Shingleton ◽  
Sachin Shinde ◽  
...  
Keyword(s):  
Mental Health ◽  
Focus Groups ◽  
Controlled Trial ◽  
Well Being ◽  
Evidence Based ◽  
Implementation Study ◽  
Single Session ◽  
Implementation Barriers ◽  
Hybrid Type

Background: Many evidence-based prevention and intervention approaches for youth mental health exist, but most are time-consuming and expensive to deliver. Innovative approaches are needed to develop and disseminate scalable mental health interventions, especially for youth in low- and middle-income countries. Computerized single-session interventions (SSIs) may be able to overcome many of these implementation barriers, especially if deployed in school settings. Methods: Guided by this logic, we designed three computerized SSIs (based on behavioral activation, gratitude, and growth mindset exercises) for delivery in Indian high schools. Then, we conducted focus groups with Indian adolescents and school officials to inform adaptations of the interventions. Finally, we designed a Hybrid Type 1 effectiveness-implementation study to evaluate the interventions. Results: In this paper, we present the rationale for selecting the interventions, the results of the focus groups, and the design of a Hybrid Type 1 effectiveness-implementation study. Our initial focus group data showed that the interventions were considered acceptable, feasible, and appropriate by both educators and students. We also describe feedback on the interventions which we incorporated to refine the interventions prior to our randomized controlled trial. Discussion: Computerized SSIs may offer innovative, scalable ways to disseminate evidence-based interventions. By identifying which interventions are most acceptable and effective in this highly scalable format, we may understand which SSIs are best suited for continued development, testing, and, ultimately, widespread dissemination.

MindMate2U: Development and feasibility study of a co-designed school-based mHealth intervention for symptomatic adolescents (Preprint)

2021 ◽  
Author(s):  
Siobhan Hugh-Jones ◽  
Kirsty Pert ◽  
Sarah Kendal ◽  
Simon Eltringham ◽  
Chris Skelton ◽  
...  
Keyword(s):  
Mental Health ◽  
High Schools ◽  
Young People ◽  
Controlled Trial ◽  
Evidence Based ◽  
Post Intervention ◽  
Low Intensity ◽  
Self Help ◽  
Web App ◽  
Parent Component

BACKGROUND Early intervention can reduce the risk of mental health disorder in young people. Given the burden on services, schools often provide frontline support, but with few resources. School-hosted mHealth is a novel option which could meet young people’s needs for privacy in mental health intervention and schools’ need for evidence-based resources. OBJECTIVE We aimed to co-design and feasibility test a self-help, school hosted, digital intervention for symptomatic adolescents in UK high schools. METHODS Extensive co-design processes integrated user and stakeholder design and implementation preferences with evidence, theory and treatment guidelines with. We conducted co-design workshops (n=14) and iterative content development reviews (n=40) with youth, parents/carers, teachers, mental health professionals and software engineers. Co-design determined the intervention aim, content, user features, implementation and evaluation protocol, and led to the production of a web-app 'MindMate2U' as well as to a low-intensity parent component ‘Partner2U’ (email psychoeducation and support). Feasibility was tested in school-selected year groups in four UK high schools where young people opted in to use MindMate2U. We specified rules for progression to an effectiveness randomised controlled trial, tested two candidate primary outcome measures (SDQ and WEMWBS) and conducted an exploratory cost-effectiveness analysis RESULTS MindMate2U is an evidence-based, six-week, self-help program targeting risk and protective factors for mental health with content released weekly to a young person’s smartphone. It met high standards of clinical safety, privacy needs and user testing before trial. Four large UK urban secondary schools opted into the study and committed to low intensity teacher training on MindMate2U, creating individual web-app accounts for participating young people, a teacher being ‘on standby’ for users and assessing any post-intervention needs. Thirty-one adolescents (15-17y) opted to use MindMate2U. Most scored in sub-clinical or clinical ranges. User ratings (n=19) and post-intervention interviews (n=6) showed acceptability of the resource. We met our recruitment, retention and pre-post measure completion targets and identified the SDQ as the most sensitive outcome measure. Young people designed release of the parent component to be under their control. Only one young person opted for this. Improvements and design parameters for an effectiveness trial were identified. CONCLUSIONS This study established the feasibility of a co-designed mental health app as a low-burden, school-hosted resource for symptomatic young people and opens up new possibilities for the integration of mHealth in schools. There is scope to consider how MindMate2U could operate within schools as an adjunct to school counselling. Support via schools to parents of symptomatic young people may need to be universal rather than targeted to protect young people’s needs for autonomy and privacy. Following some development of MM2U, a subsequent phase 2 randomized controlled trial is warranted to test its effectiveness in reducing clinical risk among symptomatic young people.

scholarly journals Effectiveness of a technology-assisted, family volunteers delivered, brief, multicomponent parents’ skills training intervention for children with developmental disorders in rural Pakistan: a cluster randomized controlled trial

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Syed Usman Hamdani ◽  
Zill-e- Huma ◽  
Nadia Suleman ◽  
Parveen Akhtar ◽  
Huma Nazir ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Developmental Disorders ◽  
Controlled Trial ◽  
Skills Training ◽  
Health Related Quality ◽  
Post Intervention ◽  
Related Quality ◽  
Health Related ◽  
Cluster Randomized

Abstract Background Globally, there is a large documented gap between needs of families and children with developmental disorders and available services. We adapted the World Health Organization’s mental health Gap-Intervention Guidelines (mhGAP-IG) developmental disorders module into a tablet-based android application to train caregivers of children with developmental disorders. We aimed to evaluate the effectiveness of this technology-assisted, family volunteers delivered, parents’ skills training intervention to improve functioning in children with developmental disorders in a rural community of Rawalpindi, Pakistan. Methods In a single-blinded, cluster randomized controlled trial, 30 clusters were randomised (1:1 ratio) to intervention (n = 15) or enhanced treatment as usual (ETAU) arm (n = 15). After screening, 540 children (18 participants per cluster) aged 2–12 years, with developmental disorders and their primary caregivers were recruited into the trial. Primary outcome was child’s functioning, measured by Childhood Disability Assessment Schedule for Developmental Disorders (DD-CDAS) at 6-months post-intervention. Secondary outcomes were parents’ health related quality of life, caregiver-child joint engagement, socio-emotional well-being of children, family empowerment and stigmatizing experiences. Intention-to-treat analyses were done using mixed-models adjusted for covariates and clusters. Results At 6-months post-intervention, no statistically significant mean difference was observed on DD-CDAS between intervention and ETAU (mean [SD], 47.65 [26.94] vs. 48.72 [28.37], Adjusted Mean Difference (AMD), − 2.63; 95% CI − 6.50 to 1.24). However, parents in the intervention arm, compared to ETAU reported improved health related quality of life (mean [SD] 65.56 [23.25] vs. 62.17 [22.63], AMD 5.28; 95% CI 0.44 to 10.11). The results were non-significant for other secondary outcomes. Conclusions In the relatively short intervention period of 6 months, no improvement in child functioning was observed; but, there were significant improvements in caregivers’ health related quality of life. Further trials with a longer follow-up are recommended to evaluate the impact of intervention. Trial registration Clinicaltrials.gov, NCT02792894. Registered April 4, 2016, https://clinicaltrials.gov/ct2/show/NCT02792894

scholarly journals Brief self-affirmation intervention for adults with psoriasis for reducing anxiety and depression and boosting well-being: Evidence from a randomized controlled trial

2021 ◽  
pp. 1-11
Author(s):  
Patryk Łakuta
Keyword(s):  
Mental Health ◽  
Health Outcomes ◽  
Active Control ◽  
Implementation Intentions ◽  
Controlled Trial ◽  
Well Being ◽  
Mental Health Outcomes ◽  
Control Group ◽  
Post Intervention

Abstract Background There are relatively few studies to address mental health implications of self-affirming, especially across groups experiencing a chronic health condition. In this study, short- and longer-term effects of a brief self-affirmation intervention framed in terms of implementation intentions (if-then plans with self-affirming cognitions; S-AII) were evaluated against an active control group (non-affirming implementation intentions; N-AII), matched to the target condition, and mere goal intention condition (a non-active control) in adults with psoriasis. The three pre-registered primary outcomes captured depression, anxiety, and well-being. Methods Adults with psoriasis (N = 175; Mage = 36.53, s.d. = 11.52) were randomized into S-AII, N-AII, or control. Participants' mental health outcomes were assessed prior to randomization (at baseline), at week 2 (post-intervention), and at a 1-month follow-up. Results Linear mixed models were used and results were reported on the intention-to-treat principle. Analyses revealed that S-AII exerted significantly more improvement in the course of well-being (ds > 0.25), depressive symptoms (ds > −0.40), and anxiety (ds > −0.45) than the N-AII and control group at 2-week post-intervention. Though the differences between groups faded at 1-month follow-up, the within-group changes over time for S-AII in all mental health outcomes remained significant. Conclusions Brief and low-intensity S-AII intervention exerted in the short-term a considerable impact on mental health outcomes. The S-AII shows promising results as a relevant public mental health strategy for enhancing well-being and reducing psychological distress. Future studies could consider whether these effects can be further enhanced with booster interventions.

scholarly journals A pragmatic randomized wait-list controlled trial of a smartphone-based well-being training in public school system employees during the COVID-19 pandemic

2021 ◽  
Author(s):  
Matthew James Hirshberg ◽  
Corrina Frye ◽  
Cortland J. Dahl ◽  
Kevin M Riordan ◽  
Nate Vack ◽  
...  
Keyword(s):  
Mental Health ◽  
Public School ◽  
School System ◽  
Controlled Trial ◽  
Well Being ◽  
Vital Role ◽  
Public School System ◽  
Wait List ◽  
Post Intervention ◽  
Secondary Outcomes

While the extraordinary pressures of the COVID-19 pandemic on student mental health have received considerable attention, less attention has been placed on the well-being of school system employees despite their vital role in society and the education of young people. The need for innovative mental health promotion strategies that are acceptable, accessible, and scalable has never been more evident. In a remote pragmatic randomized wait-list controlled trial of Wisconsin public school system employees (N=662) during the COVID-19 pandemic, we investigate a candidate program: a freely available four-week smartphone-based meditation app designed to train key constituents of well-being (Healthy Minds Program; HMP). Following our preregistered analysis plan and consistent with hypotheses, assignment to the HMP predicted significantly larger reductions in psychological distress, our primary outcome, at post-intervention (standardized mean difference (SMD)=-0.52 95% CI [-0.68 to -0.37], P<0.0001) and at the three-month follow-up (SMD=-0.33 [-0.48 to -0.18], P<0.001). Also consistent with hypotheses, similar indications of immediate and sustained benefit following the HMP were observed on all six preregistered secondary outcomes selected to tap skills targeted in the app (absolute value SMDs=0.19 to 0.42, all Ps<0.031 corrected). Secondary outcomes included an antecedent to anxiety and depression (perseverative thinking) and a measure of loneliness. We found no evidence for elevated adverse effects in the HMP group and the HMP was at least as effective in subsample analyses involving participants with elevated anxiety and depressive symptoms at baseline. These data suggest that the HMP has promise as an acceptable, accessible, and scalable mental health intervention.

scholarly journals Promoting Mental Health and Well-Being among Adolescent Young Carers in Europe: A Randomized Controlled Trial Protocol

2021 ◽  
Vol 18 (4) ◽  
pp. 2045
Author(s):  
Giulia Casu ◽  
Valentina Hlebec ◽  
Licia Boccaletti ◽  
Irena Bolko ◽  
Alessandra Manattini ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Primary Prevention ◽  
Study Protocol ◽  
Controlled Trial ◽  
Well Being ◽  
Evidence Based ◽  
Young Carers ◽  
Randomized Controlled ◽  
Health And Well Being

It is estimated that 4–8% of youth in Europe carry out substantial care for a family member or significant other. To prevent adverse psychosocial outcomes in young carers (YCs), primary prevention resilience building interventions have been recommended. We describe the study protocol of an international randomized controlled trial (RCT) of an innovative group intervention designed to promote the mental health and well-being of adolescent YCs (AYCs) aged 15–17. The RCT will be conducted in six European countries in the context of the Horizon 2020 European funded research and innovation project “Psychosocial support for promoting mental health and well-being among adolescent young caregivers in Europe” (“ME-WE”). The ME-WE intervention is based on Hayes and Ciarrochi’s psychoeducational model for adolescents and will consist of seven 2-h sessions in a group format, aimed to help AYCs build psychological flexibility and live according to their values. The control group will be a waitlist. Primary and secondary outcomes and control variables will be measured at baseline (T0), post-intervention (T1) and 3 months follow-up (T2). The COVID-19 pandemic has made amendments necessary to the original study protocol methodology, which we describe in detail. This study will contribute to building an evidence-based manualized program that educators and health and social care professionals can use to support AYCs in their transition to adulthood. From a research perspective, the outcomes of this study will contribute to evidence-based practices in primary prevention of psychosocial difficulties in AYCs and will gather novel knowledge on the effectiveness of Hayes and Ciarrochi’s model for use with middle adolescents with caring responsibilities. The trial has been preregistered (registration number: NCT04114864).

Transdiagnostic versus Diagnosis-Specific Group Cognitive Behavioral Therapy for Anxiety Disorders and Depression: A Randomized Controlled Trial

2021 ◽  
pp. 1-14
Author(s):  
Nina Reinholt ◽  
Morten Hvenegaard ◽  
Anne Bryde Christensen ◽  
Anita Eskildsen ◽  
Carsten Hjorthøj ◽  
...  
Keyword(s):  
Mental Health ◽  
Mental Health Services ◽  
Health Services ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Well Being ◽  
Major Depressive ◽  
Outpatient Mental Health ◽  
End Of Treatment

<b><i>Introduction:</i></b> The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) delivered in a group format could facilitate the implementation of evidence-based psychological treatments. <b><i>Objective:</i></b> This study compared the efficacy of group UP and diagnosis-specific cognitive behavioral therapy (dCBT) for anxiety and depression in outpatient mental health services. <b><i>Methods:</i></b> In this pragmatic, multi-center, single-blinded, non-inferiority, randomized controlled trial (RCT), we assigned 291 patients with major depressive disorder, social anxiety disorder, panic disorder, or agoraphobia to 14 weekly sessions in mixed-diagnosis UP or single-diagnosis dCBT groups. The primary test was non-inferiority, using a priori criteria, on the World Health Organisation 5 Well-Being Index (WHO-5) at the end of the treatment. Secondary outcomes were functioning and symptoms. We assessed outcomes at baseline, end-of-treatment, and at a 6-month follow-up. A modified per-protocol analysis was performed. <b><i>Results:</i></b> At end-of-treatment, WHO-5 mean scores for patients in UP (<i>n</i> = 148) were non-inferior to those of patients in dCBT (<i>n</i> = 143; mean difference –2.94; 95% CI –8.10 to 2.21). Results were inconclusive for the WHO-5 at the 6-month follow-up. Results for secondary outcomes were non-inferior at end-of-treatment and the 6-month follow-up. Client satisfaction and rates of attrition, response, remission, and deterioration were similar across conditions. <b><i>Conclusions:</i></b> This RCT demonstrated non-inferior acute-phase outcomes of group-delivered UP compared with dCBT for major depressive disorder, social anxiety disorder, panic disorder, and agoraphobia in outpatient mental health services. The long-term effects of UP on well-being need further investigation. If study findings are replicated, UP should be considered a viable alternative to dCBT for common anxiety disorders and depression in outpatient mental health services.

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