Syed Usman Hamdani

Effectiveness of the parent-mediated intervention for children with autism spectrum disorder in south Asia in India and Pakistan (PASS): a randomised controlled trial

BACKGROUND Autism spectrum disorder affects more than 5 million children in south Asia. Although early interventions have been used for the treatment of children in high-income countries, no substantive trials have been done of the interventions adapted for use in low-income and middle-income countries (LMICs). We therefore assessed the feasibility and acceptability of the parent-mediated intervention for autism spectrum disorder in south Asia (PASS) in India and Pakistan. METHODS A single-blind randomised trial of the comparison of 12 sessions of PASS (plus treatment as usual) with treatment as usual alone delivered by non-specialist health workers was done at two centres in Goa, India, and Rawalpindi, Pakistan. Children aged 2-9 years with autism spectrum disorder were randomly assigned (1:1) by use of probabilistic minimisation, controlling for treatment centre (Goa or Rawalpindi), age (<6 years or ≥6 years), and functional impairment (Vineland Adaptive Behaviour Scale Composite score <65 or ≥65). The primary outcome was quality of parent-child interaction on the Dyadic Communication Measure for Autism at 8 months. Analysis was by intention to treat. The study is registered with ISRCTN, number ISRCTN79675498. FINDINGS From Jan 1 to July 30, 2013, 65 children were randomly allocated, 32 to the PASS group (15 in Goa and 17 in Rawalpindi) and 33 to the treatment-as-usual group (15 in Goa and 18 in Rawalpindi). 26 (81%) of 32 participants completed the intervention. After adjustment for minimisation factors and baseline outcome, the primary outcome showed a treatment effect in favour of PASS in parental synchrony (adjusted mean difference 0·25 [95% CI 0·14 to 0·36]; effect size 1·61 [95% CI 0·90 to 2·32]) and initiation of communication by the child with the parent (0·15 [0·04 to 0·26]; effect size 0·99 [0·29 to 1·68]), but time in mutual shared attention was reduced (-0·16 [-0·26 to -0·05]; effect size -0·70 [-1·16 to -0·23]). INTERPRETATION Our results show the feasibility of adapting and task-shifting an intervention used in a high-income context to LMICs. The findings also replicate the positive primary outcome treatment effects of a parent-mediated communication-focused intervention in the original UK Preschool Autism Communication Trial, with one negative effect not reported previously. FUNDING Autism Speaks, USA.

Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial

Importance The mental health consequences of conflict and violence are wide-ranging and pervasive. Scalable interventions to address a range of mental health problems are needed. Objective To test the effectiveness of a multicomponent behavioral intervention delivered by lay health workers to adults with psychological distress in primary care settings. Design, Setting, and Participants A randomized clinical trial was conducted from November 1, 2014, through January 28, 2016, in 3 primary care centers in Peshawar, Pakistan, that included 346 adult primary care attendees with high levels of both psychological distress and functional impairment according to the 12-item General Health Questionnaire and the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Interventions Lay health workers administered 5 weekly 90-minute individual sessions that included empirically supported strategies of problem solving, behavioral activation, strengthening social support, and stress management. The control was enhanced usual care. Main Outcomes and Measures Primary outcomes, anxiety and depression symptoms, were independently measured at 3 months with the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes were posttraumatic stress symptoms (Posttraumatic Stress Disorder Checklist for DSM-5), functional impairment (WHODAS 2.0), progress on problems for which the person sought help (Psychological Outcome Profiles), and symptoms of depressive disorder (9-item Patient Health Questionnaire). Results Among 346 patients (mean [SD] age, 33.0 [11.8] years; 78.9% women), 172 were randomly assigned to the intervention and 174 to enhanced usual care; among them, 146 and 160 completed the study, respectively. At baseline, the intervention and control groups had similar mean (SD) HADS scores on symptoms of anxiety (14.16 [3.17] vs 13.64 [3.20]; adjusted mean difference [AMD], 0.52; 95% CI, -0.22 to 1.27) and depression (12.67 [3.27] vs 12.49 [3.34]; AMD, 0.17, 95% CI, -0.54 to 0.89). After 3 months of treatment, the intervention group had significantly lower mean (SD) HADS scores than the control group for anxiety (7.25 [3.63] vs 10.03 [3.87]; AMD, -2.77; 95% CI, -3.56 to -1.98) and depression (6.30 [3.40] vs 9.27 [3.56]; AMD, -2.98; 95% CI, -3.74 to -2.22). At 3 months, there were also significant differences in scores of posttraumatic stress (AMD, -5.86; 95% CI, -8.53 to -3.19), functional impairment (AMD, -4.17; 95% CI, -5.84 to -2.51), problems for which the person sought help (AMD, -1.58; 95% CI, -2.40 to -0.77), and symptoms of depressive disorder (AMD, -3.41; 95% CI, -4.49 to -2.34). Conclusions and Relevance Among adults impaired by psychological distress in a conflict-affected area, lay health worker administration of a brief multicomponent intervention based on established behavioral strategies, compared with enhanced usual care, resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months. Trial Registration anzctr.org.au Identifier: ANZCTR12614001235695.

Adapting an evidence-based intervention for autism spectrum disorder for scaling up in resource-constrained settings: the development of the PASS intervention in South Asia

Background Evidence-based interventions for autism spectrum disorders evaluated in high-income countries typically require highly specialised manpower, which is a scarce resource in most low- and middle-income settings. This resource limitation results in most children not having access to evidence-based interventions. Objective This paper reports on the systematic adaptation of an evidence-based intervention, the Preschool Autism Communication Therapy (PACT) evaluated in a large trial in the United Kingdom for delivery in a low-resource setting through the process of task-shifting. Design The adaptation process used the Medical Research Council framework for the development and adaptation of complex interventions, focusing on qualitative methods and case series and was conducted simultaneously in India and Pakistan. Results The original intervention delivered by speech and language therapists in a high-resource setting required adaptation in some aspects of its content and delivery to enhance contextual acceptability and to enable the intervention to be delivered by non-specialists. Conclusions The resulting intervention, the Parent-mediated intervention for Autism Spectrum Disorder in South Asia (PASS), shares the core theoretical foundations of the original PACT but is adapted in several respects to enhance its acceptability, feasibility, and scalability in low-resource settings.

Parents’ perspectives on care of children with autistic spectrum disorder in South Asia – Views from Pakistan and India

Abstract Autism spectrum disorder (ASD) affects about 1.4% of the population in South Asia but very few have access to any form of health care service. The objective of this study was to explore the beliefs and practices related to the care of children with ASD to inform strategies for intervention. In Pakistan, primary data were collected through in-depth interviews of parents (N = 15), while in India a narrative review of existing studies was conducted. The results show that the burden of care is almost entirely on the mother, leading to high levels of stress. Poor awareness of the condition in both family members and front-line health-providers leads to delay in recognition and appropriate management. There is considerable stigma and discrimination affecting children with autism and their families. Specialist services are rare, concentrated in urban areas, and inaccessible to the majority. Strategies for intervention should include building community and family support networks to provide respite to the main carer. In the absence of specialists, community members such as community health workers, traditional practitioners and even motivated family members could be trained in recognizing and providing evidence-based interventions. Such task-shifting strategies should be accompanied by campaigns to raise awareness so greater inclusivity can be achieved.

Model for Service Delivery for Developmental Disorders in Low-Income Countries.

As in many low-income countries, the treatment gap for developmental disorders in rural Pakistan is near 100%. We integrated social, technological, and business innovations to develop and pilot a potentially sustainable service for children with developmental disorders in 1 rural area. Families with developmental disorders were identified through a mobile phone–based interactive voice response system, and organized into “Family Networks.” “Champion” family volunteers were trained in evidence-based interventions. An Avatar-assisted Cascade Training and information system was developed to assist with training, implementation, monitoring, and supervision. In a population of ∼30 000, we successfully established 1 self-sustaining Family Network consisting of 10 trained champion family volunteers working under supervision of specialists, providing intervention to 70 families of children with developmental disorders. Each champion was responsible for training and providing ongoing support to 5 to 7 families from his or her village, and the families supported each other in management of their children. A pre-post evaluation of the program indicated that there was significant improvement in disability and socioemotional difficulties in the child, reduction in stigmatizing experiences, and greater family empowerment to seek services and community resources for the child. There was no change in caregivers’ well-being. To replicate this service more widely, a social franchise model has been developed whereby the integrated intervention will be “boxed” up and passed on to others to replicate with appropriate support. Such integrated social, technological, and business innovations have the potential to be applied to other areas of health in low-income countries.

Problem Management Plus (PM+): pilot trial of a WHO transdiagnostic psychological intervention in conflict‐affected Pakistan

The mental health consequences of conflict and natural disaster are substantial and wide‐ranging1, 2. There is an urgent need for interventions by non‐specialist workers that can address a range of mental health problems3. The World Health Organization (WHO)s Problem Management Plus (PM+) is a brief transdiagnostic psychological intervention employing evidence‐based strategies of problem solving, behavioural activation, strengthening social support, and stress management4. We adapted the individual treatment format of this intervention for conflict‐affected Peshawar in Pakistan. It consisted of five face‐to‐face sessions, with a key feature of being affordable in most settings, because it can be offered not only by specialists but also by supervised non‐specialists with no prior training or experience in mental health care delivery. We used an apprenticeship (on‐the‐job learning) model for training and supervising the non‐specialists5, which involved an initial 6‐day training programme by a master trainer to local mental health specialists, who in turn provided an 8‐day training programme to six non‐specialists. Training of both supervisors and non‐specialists was followed by four weeks of practice under supervision of the local trainers. The local trainers themselves were supervised 3‐weekly through audio calls by the master trainer, building skills in the intervention as well as in training and supervision. All non‐specialists were evaluated for their competency by independent assessors using a competency rating tool evaluating basic helping skills and use of PM+ strategies through observation of specially designed role plays. Competency was rated using a 5‐point scale. In total, four out of six achieved scores indicating competency in all basic helping skills and five out of six achieved all competency scores on PM+ strategies. Following additional training and supervision, all non‐specialists demonstrated adequate proficiency in requisite skills. We conducted a single‐blind pilot randomized controlled trial (RCT) to explore the feasibility and acceptability of the intervention in Peshawar. PM+ was compared to enhanced treatment as usual, consisting of management by primary care physician who received one day of basic training in treatment of common mental disorders. The study was conducted from March to May 2014 in two primary care centres in Gulbahar Union Council, a low‐income peri‐urban locality in Peshawar district. Participants were primary care attenders aged 18 or above, referred for screening by the primary care physician. Screening was conducted by trained members of the research team following informed consent to recruit persons with both marked distress and impairment. Invited participants scored: a) 2 or above on the General Health Questionnaire (GHQ‐12)6, a 12 item questionnaire of general psychological distress with a 4‐point scale ranging from 0 to 3 scored bi‐modally when used as a screener (possible range 0‐12), and b) 17 or above on the WHO Disability Assessment Schedule (WHODAS 2.0)7, a screener for functional impairment with 12 items measured on a scale ranging from 1 to 5 (possible range 12‐60). We excluded individuals with imminent suicide risk, severe cognitive impairment (e.g., severe intellectual disability or dementia) or with expressed acute needs/protection risks (e.g., recent abandonment by husband and his family). We also excluded individuals who reported having experienced a major traumatic event during the past month and individuals with severe mental disorder (psychotic disorders, substance dependence). Individuals meeting the exclusion criteria were referred to specialist centres depending upon their needs. Ethical approvals were obtained from the Ethics Review Board at the Lady Reading Hospital, Peshawar, and WHOs Ethical Review Committee. Approval was also obtained from the district primary care administration. Participants were interviewed after voluntary written consent. Out of 1,286 people seen by a physician during the study period, 94 were referred for screening, 85 met study criteria, 81 were accessible, and 60 consented to participate in the trial. Randomization to the PM+ intervention or enhanced treatment as usual was performed by an independent researcher not involved in the project using computerized software on a 1:1 basis, stratified for gender. Nine out of 60 (15%) – five from the intervention arm and four from the control arm – were lost to follow‐up. The groups were well‐balanced at baseline for demographic and clinical variables. The primary outcome, assessed by independent raters, was psychological distress, measured by GHQ‐12 with scores being the total sum across 12 items (possible range 0‐36). Other outcomes included: functioning, measured using the 12‐item interviewer‐administered screener version of the WHODAS 2.0; and post‐traumatic stress symptoms, measured using the PTSD Checklist for DSM‐5 (PCL‐5)8, which is a 20‐item checklist corresponding to the twenty DSM‐5 PTSD symptoms in the last week, with items rated on a 0‐4 scale (possible range 0‐80). The intervention had high uptake, with 22/30 (73%) completing all sessions. The intervention arm showed improvement in functioning (mean WHODAS 2.0 scores reduced from 17.7 ± 9.2 to 6.6 ± 6.1 vs. 17.0 ± 10.5 to 11.3 ± 10.4 in controls) and in post‐traumatic stress symptoms (mean PCL‐5 scores reduced from 34.2 ± 20.1 to 9.8 ± 9.1 vs. 32.3 ± 17.1 to 19.5 ± 18.5 in controls). Due to skewed distribution and variance heterogeneity of the outcome variable, log‐linear regression was carried out. After adjustment of baseline scores, the results showed a reduction of 90% in geometric mean within the intervention group (95% CI: 90.4%‐91.7%, p=0.04) in WHODAS 2.0 scores and a reduction of 92% (95% CI: 91.2%‐92.3%, p=0.02) in post‐traumatic stress symptoms. There was no significant change in GHQ‐12 scores. On qualitative evaluation of a sub‐sample of participants and primary care staff, we found that the intervention was perceived as useful, and was successfully integrated into primary care centres. As this was a pilot study with a small sample size, recruited through primary care physician referral, and no power calculations were carried out, the findings and their generalizability warrant a cautious interpretation. However, a successful conduction in challenging settings, with adequate enrolment rate, a low drop‐out, and balanced randomization provides evidence that RCTs are feasible in such settings. The intervention delivery through non‐specialists with no prior mental health care experience and the encouraging results demonstrate the feasibility of the task shifting approach, and are consistent with previous reports9, 10. The results of this pilot study should encourage further adaptation and large‐scale fully‐powered RCTs of this new, transdiagnostic psychological intervention4. Atif Rahman1,2, Naila Riaz3, Katie S. Dawson4, Syed Usman Hamdani2, Anna Chiumento1, Marit Sijbrandij5, Fareed Minhas6, Richard A. Bryant4, Khalid Saeed7, Mark van Ommeren8, Saeed Farooq3 1University of Liverpool, Liverpool, UK; 2Human Development Research Foundation, Islamabad, Pakistan; 3Lady Reading Hospital, Peshawar, Pakistan; 4University of New South Wales, Sydney, Australia; 5VU University Amsterdam, Amsterdam, The Netherlands; 6Institute of Psychiatry, Rawalpindi, Pakistan; 7Mental Health and Substance Abuse Unit, Regional Office for the Eastern Mediterranean Region, World Health Organization, Cairo, Egypt; 8Department of Mental Health and Substance Abuse, World Health Organization, Geneva, Switzerland

Family networks to improve outcomes in children with intellectual and developmental disorders: a qualitative study

BackgroundThere are at least 50 million children with an intellectual or developmental disorder in South Asia. The vast majority of these children have no access to any service and there are no resources to develop such services. We aimed to explore a model of care-delivery for such children, whereby volunteer family members of affected individuals could be organized and trained to form an active, empowered group within the community that, a) using a task-sharing approach, are trained by specialists to provide evidence-based interventions to their children; b) support each other, with the more experienced FaNs i.e. family networks, providing peer-supervision and training to new family members who join the group; and c) works to reduce the stigma associated with the condition.MethodsWe used qualitative methods to explore carers’ perspectives about such a care-delivery model.ResultsThe key findings of this research are that there is a huge gap between the needs of the carers and available services. Carers would welcome a volunteer-led service, and some community members would have time to volunteer. Raising community awareness in a culturally sensitive manner prior to launching such a service and linking it to the community health workers programme would increase the likelihood of success. Gender-matching would be important. It would be possible to form family networks around the more motivated volunteers, with support from local non-governmental organizations. The carers were receptive to the use of technology to assist the work of the volunteers as well as for networking.ConclusionsWe conclude that family volunteers delivering evidence-based packages of care after appropriate training is a feasible system that can help reduce the treatment gap for childhood intellectual and developmental disorders in under-served populations.

Evaluating feasibility and acceptability of a group WHO trans-diagnostic intervention for women with common mental disorders in rural Pakistan: a cluster randomised controlled feasibility trial.

AIMS The aim of this feasibility trial was to evaluate the feasibility and acceptability of the locally adapted Group Problem Management Plus (PM+) intervention for women in the conflict affected settings in Swat, Pakistan. METHODS This mixed-methods study incorporated a quantitative component consisting of a two arm cluster randomised controlled feasibility trial, and qualitative evaluation of the acceptability of the Group PM+ to a range of stakeholder groups. For the quantitative component, on average from each of the 20 Lady Health Workers (LHWs) catchment area (20 clusters), six women were screened and recruited for the trial with score of >2 on the General Health Questionnaire and score of >16 on the WHO Disability Assessment Schedule. These LHW clusters were randomised on a 1 : 1 allocation ratio using a computer-based software through a simple randomisation method to the Group PM+ intervention or Enhanced Usual Care. The Group PM+ intervention consisted of five weekly sessions of 2 h duration delivered by local non-specialist females under supervision. The primary outcome was individual psychological distress, measured by levels of anxiety and depression on the Hospital Anxiety and Depression Scale at 7th week after baseline. Secondary outcomes include symptoms of depression, post-traumatic stress disorder (PTSD), general psychological profile, levels of functioning and generalised psychological distress. Intervention acceptability was explored through in-depth interviews. RESULTS The results show that lay-helpers with no prior mental health experience can be trained to achieve the desired competency to successfully deliver the intervention in community settings under supervision. There was a good intervention uptake, with Group PM+ considered useful by participants, their families and lay-helpers. The outcome evaluation, which was not based on a large enough study to identify statistically significant results, indicated statistically significant improvements in depression, anxiety, general psychological profile and functioning. The PTSD symptoms and depressive disorder scores showed a trend in favour of the intervention. CONCLUSION This trial showed robust acceptance in the local settings with delivery by non-specialists under supervision by local trained females. The trial paves the way for further adaptation and exploration of the outcomes through larger-scale implementation and definitive randomised controlled trials in the local settings.

Supporting Intervention Providers and Families in South Asia

South Asia is one of the most densely populated geographical regions in the world with a young and fast-growing population. The region is characterized by widespread poverty, poor health and social-care infrastructure, and high rates of illiteracy. In recent decades, parts of the region have shown rapid economic development, leading to urbanization and rising social inequality. It is estimated that the region has about 10 million children with autism spectrum disorder (ASD), and the majority have little or no access to any type of service. This chapter reviews existing practices of care for children with ASD in low-income settings in the region and describes some recent advances in supporting intervention providers and families caring for these children.

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.

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 childs functioning, measured by WHO Disability Assessment Schedule – child version (WHODAS-Child) at 6 months post intervention. Secondary outcomes include childrens 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.