NCT04255472.

Study name	Effectiveness of the WHO Caregivers Skills Training (CST) Program for children with developmental disorders and delays in rural community settings in Pakistan
Methods	Study design: RCT Country: Pakistan
Participants	Children (2‐9 years) with developmental disorders Inclusion criteria:  a. aged 2‐9 years old, with developmental disorders and delays as screened by TQS; b. screened positive on communication problems as identified by Communication and Symbolic Behavior Scale (CSBS) score < 41; c. developmental Disability‐Children's Global Assessment Scale (DD‐CGAS) score ≥ 51 as assessed by clinician. Exclusion criteria: a. epilepsy with seizures in the previous 6 months; b. cerebral palsy as assessed by the clinician; c. comorbid physical and mental conditions in the child that require inpatient hospitalization; d. significant uncorrected hearing and visual impairment in child or parent; e. any severe psychiatric or physical illness in primary caregiver requiring inpatient hospitalization. Stated purpose: to evaluate the effectiveness of the WHO CST program plus treatment‐as‐usual (TAU) vs. TAU to improve caregiver‐child interaction in children with developmental disorders and delays, when implemented by non‐specialist health care facilitators in low‐resource rural community settings of Rawalpindi, Pakistan
Interventions	Intervention: WHO Caregivers Skills Training (CST) Program Caregivers are provided with tangible strategies to appropriately respond to their children's emotional regulation, engagement, and communication. Further, the programme focuses on helping caregivers to develop their children's communication and adaptive skills while reducing challenging behaviour by focusing on identifying the function of the behaviour and learning to teach developmentally appropriate replacement skills. The WHO CST program includes nine group sessions delivered at a community venue (e.g. school, home) and three home visits: the first at entry prior to session 1, the second after session 4, and the third after the final group session. Participants will receive 3‐hour group training sessions of WHO CST programme once every week for 9 weeks and 3 individual home sessions delivered via non‐specialist health care facilitators over a duration of 3 months. Training for programme facilitators will be included prior to the delivery of the intervention. Control: Usual care (TAU in primary healthcare centres for childhood developmental disorders and delays usually consists of no treatment, or a range of alternate treatment regimens, such as multi‐vitamin syrups and tablets. Evidence‐based mental health care is currently not available in primary healthcare centres. A complete record of services availed by the trial participants at tertiary mental healthcare centres will be maintained by using an adapted Client Services Receipt Inventory (CSRI) for children with developmental disorders and delays at baseline and end point).
Outcomes	Participants'outcomes of interest for this review Quality of life – Pediatric Quality of Life, Family impact module (PedsQL) Mental health symptoms (children emotional and behavioural problems) – Child Behavior Checklist (CBCL) Economic outcomes Health services utilization ‐ Client Services Receipt Inventory, adapted (CSRI) Time points: baseline, post‐intervention (9 months post‐intervention)
Starting date	11 February 2020
Contact information	Syed Usman Hamdani, usman.hamdani@hdrfoundation.org
Notes	Source of funding: Human Development Research Foundation, Pakistan Prospective trial registration number: NCT04255472