Divan 2019.

Study characteristics
Methods	Study design: RCT; 2‐arm single (assessor)‐blinded  Duration of study: January to December 2016
Participants	Country: India  Income classification: lower‐middle income in 2016   Geographical scope: rural; Kolhapur, Maharashtra, India   Healthcare setting: participants' homes  Mental health condition: autism spectrum disorder  Population: children with autism and their parents (parent‐child dyads)  1. Age: children 2 to 9 years old  2. Gender: children – both   3. Socioeconomic background: more than half of participants' mothers had received undergraduate education or higher  4. Inclusion criteria (including threshold cutoff score of measurement tool)  a. Development age 12 months or older b. Diagnosis of autism spectrum disorder using the INCLEN Diagnostic Tool for Autism Spectrum Disorder (Juneja et al, 2014)   5. Exclusion criteria  a. Children with uncontrolled epileptic seizures, severe hearing, or visual impairment b. Residence outside trial area c. Parents with severe hearing or visual impairment, severe psychiatric disorder, residence outside the trial area
Interventions	Stated purpose: to evaluate the feasibility and effectiveness of the PASS Plus intervention for Autism Spectrum Disorders compared to usual care  INTERVENTION 1 (n = 19) Name: parent‐mediated intervention for autism spectrum disorder plus (PASS Plus)  Delivered by: LHW Title/name of PW and number: facilitators (lay health workers) ‐ 4  1. Selection: a first‐stage competency assessment evaluated knowledge and skills of selected candidates, who were then allowed to co‐deliver the intervention to non‐trial practice dyads under supervision. During 1‐month internship period, each trainee delivered a minimum of 3 sessions independently, after which a second‐level objective competency assessment was administered on PASS specific knowledge and skills. Those who achieved a pre‐determined competency score then engaged with trial dyads. Two months into the case practice sessions, lay health workers received an additional 2‐day training on Plus modules  2. Educational background: college graduates  3. Training (contents, duration, by whom): 10‐day training by senior clinicians and mid‐level supervisor, which included classroom‐based instruction on child development and autism, observations in special education settings of children with social communication impairments, and practice‐based learning of the modular intervention PASS  4. Supervision: first session on engagement was conducted with a supervisor present. All sessions were videotaped, and these were used initially for one‐on‐one supervision by PASS Plus trainers. Over the trial period, supervision evolved from initial high‐intensity group supervision conducted once a week by a senior clinician to peer‐led supervision. These were then supervised every fortnight by senior clinicians. The implementation team was rated on fidelity measures conducted by a therapy expert based in the UK on 10% of randomly selected treatment sessions  Intervention details (according to PWs and whether aimed at carers and/or patients)  1. Duration/frequency: twelve 60‐ to 90‐minute fortnightly sessions over a 6‐month period  2. Content of intervention (by types of health workers and per patients/carers): 2 distinct manualised components: PASS social communication modules and “Plus” comorbidity modules. During the core social communication intervention (PASS), facilitators used video feedback on play sessions recorded during a 10‐minute period of play between parent and child to support the parent to recognise the child’s non‐verbal and verbal signals, which reflect the child’s communication intentions, and to recognise which of their own actions have a positive effect on the interaction. The parent is then guided to choose intervention strategies, which include simple but effective strategies such as paying attention to parent positioning, watching and waiting, and reducing the use of questions and directives to try out and the effects of these on their dyadic interaction, which is reviewed at the start of the next session. Plus modules address common comorbidities via a psychosocial approach and are introduced in the fourth session. After supporting the parent to identify the comorbidity most disruptive for the family, the decision algorithm enables the facilitator to identify the most relevant advice and strategies for the family. Parents are requested to practise the communication strategies for 30 minutes every day in the intervening fortnight   CONTROL: usual care. (n = 21) Participants were able to access regular treatment: children visited allopathic private doctors and Ayurvedic/homeopathic doctors  CO‐INTERVENTIONS: participants in both arms were able to access regular treatment. About 15% of the children in both groups attended a specialist school, and about half attended mainstream schools. Schools offered largely respite care with some remedial education, with no specific intervention for autism
Outcomes	Patients  1. Autism symptom severity – Brief Observation of Social Communication Change (BOSCC)*   2. Dyadic Communication Measure for Autism (DCMA)* ‐ proportion of parent synchronous responses, proportion of child acts of communication initiation, proportion of time in shared attention  3. Comorbidity severity ‐ Developmental Behaviour Checklist (DBC)   4. Adaptive child behaviours ‐ standard Vineland Adaptive Behaviour Scale (VABS) total score and communication, receptive, expressive, written, and socialisation sub‐scores   Carers  1. Parental mental well‐being ‐ PHQ‐9   2. Parent self‐perception of knowledge, skills, acceptance, empowerment, and advocacy, using a measure adapted from the Research on Autism and Families in India (RAFIN) study (Daley 2013) (the RAFIN tool)  Process/health workers Nil  Economic outcomes  Nil  (asterisk for study's primary outcomes; star: outcomes that we have not reported in this review)  Time points post end of intervention: 0 months
Notes	Source of funding: Grand Challenges Canada Global Mental Health Stream  Notes on validation of instruments (screening and outcomes): validated  Additional information: study protocol available. Declaration of interests ‐ study authors declared no competing interests Handling the data: nil  Prospective trial registration number: ISRCTN10260663.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Each child participant was assigned a sequential identification number that was sent to an independent randomisation centre. Randomisation lists were stratified by age and by functional impairment
Allocation concealment (selection bias)	Low risk	Allocation was conveyed by telephone and by email to the site co‐ordinator, who communicated with the intervention team. Research members of staff were masked to treatment allocation
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants and interventionists were not blinded, but this was unlikely to have influenced outcomes
Blinding of outcome assessment (detection bias) all outcomes	Low risk	Assessors were masked to participants' allocation and to the time point at which participants were videotaped
Baseline outcome measurements similar	Low risk	Baseline outcome measurements were similar in both groups
Baseline characteristics similar?	Low risk	Baseline characteristics of the 2 groups (age, gender, mother's educational level) were similar
Incomplete outcome data (attrition bias) Efficacy data	Unclear risk	Small sample size: attrition rate of 12.5% (5/40); participants who had dropped out may have influenced results had they stayed
Incomplete outcome data (attrition bias) Safety data (e.g. adverse events)	Low risk	Low attrition and no safety issues; 2 participants dropped out because of intervention (1 withdrew because parent did not understand intervention; 1 family withdrew because they felt the intervention was not relevant to the child's difficulties). No safety issues were reported
Protection against contamination	Low risk	No participants received speech, language, or occupational therapy nor physiotherapy during the trial period. Although participants attended specialist or mainstream schools, these had no notable specific intervention for autism. Control group participants were not exposed to the intervention, as the intervention was home‐based and was delivered by trained workers
Selective reporting (reporting bias)	Unclear risk	All outcomes planned in the methods section were reported in the results section. As this was a pilot trial, trial protocol was not published online
Other bias	Low risk	Nil