Hamdani 2021a.
| Study characteristics | |
| Methods |
Study design: cluster‐RCT Duration of study: the study was conducted from April 2016 to April 2018. Country: Pakistan Income classification: lower‐middle income country in 2017 Geographical scope: rural subdistrict of Gujar Khan in Rawalpindi district Healthcare setting: village‐based groups |
| Participants | 1. Age: mean (SD) age of children was 6.72 (± 2.76). 2. Gender: both 3. Socioeconomic background: mean monthly income 19,236.65 (SD 17,617.78) Pakistani rupees 4. Educational background: mothers’ literacy, 33% (177/540) of mothers had no formal education, whereas 56% (303/540) of mothers had completed some schooling (7 [± 1.5] years of schooling) Inclusion criteria: a. trial participants were children aged between 2 and 12 years, residing in the study subdistrict for the duration of the study; b. positive score on any of the Ten Questions Screen questionnaire items 1, 4, 5, 7, 8, 9, 10 for neurodevelopmental delay—a cross‐culturally valid instrument to screen children with developmental difficulties; c. clinical assessment of screened‐positive children with developmental delays and disorder(s) according to the WHO mhGAP developmental disorders guidelines for clinical assessment in primary healthcare settings by a trained clinical psychologist. Exclusion criteria: not specified. Note: considerations on baseline scores not applicable for this study Stated purpose: to evaluate the effectiveness of this technology (assisted), delivered by family volunteers; parents’ skills training intervention to improve functioning in children with developmental disorders in a rural community of Rawalpindi, Pakistan |
| Interventions |
Name: WHO mhGAP guidelines‐based intervention Title/name of PW and number: 62 family volunteers (FVs), facilitators from the community 1. Selection: either the parents or others who were related to the children with developmental disorders, had at least eight grades of formal education, and volunteered to be trained and supervised by the trainers for at least 6 months duration of the programme. 2. Educational background: at least eight grades of formal education 3. Training: 9 weekly group sessions followed by competency rating using adapted version of ENACT using tablet‐based tool. Provided by 10 trainers who had completed at least a Masters in Clinical Psychology and had at least 1 year of experience in working with children and families with developmental disorders. Only competent trainers (mean score above 2.5 on all domains of adapted version of ENACT) were allowed to train and supervise the FVs. 4. Supervision: FVs were fortnightly supervised by the trainers during the programme delivery; similarly, trainers were supervised fortnightly by the master trainer. 5. Incentives/remuneration: not specified Prevention type: selective—participants were included based upon the presence of a risk factor (caregivers of children with a developmental delay). Intervention details: intervention based on the guidelines of WHO mhGAP‐IG module on developmental disorders. The adapted intervention consists of 9 sessions delivered in a group format to caregivers of children with developmental disorders. Control: usual care (ETAU [enhanced treatment‐as‐usual]), including (a) Community Health Workers (CHWs), in the ETAU arm received training in recognizing signs and symptoms of developmental disorders and making referrals to their primary care physicians for treatment; and (b) the primary care physicians received a half‐day orientation session on identification, management and referral guidelines of WHO mhGAP on developmental disorders. |
| Outcomes |
Participants’outcomes of interest for this review
Carers’ outcomes of interest for this review Nil Economic outcomes Nil Time points: baseline, post‐intervention (1‐6 months) |
| Notes |
Source of funding: Grand Challenges, Canada and the Government of Canada (Grant number 0746‐05‐GMH). Matched funding was provided by Autism Speaks (Grant number 10377), USA and Human Development Research Foundation, Islamabad, Pakistan. Notes on validation of instruments (screening and outcomes): the PedsQL has shown sound psychometric properties in different cultures. Additional information: none Handling the data: not applicable Prospective trial registration number: trial registration clinicaltrials.gov, NCT02792894 |