Clinical trial NCT04255472: Effectiveness of the WHO Caregivers Skills Training Program
Official title: Effectiveness of the WHO Caregivers Skills Training (CST) Program for Children With Developmental Disorders and Delays in Rural Community Settings in Pakistan: An Individual Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Development Delay
Developmental Disorder
Language Delay
Behavioral Problem
Emotional Problem
Maternal Distress
Lead sponsor: Human Development Research Foundation, Pakistan
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: University of Liverpool
name: WHO Collaborating Center for mental health research, Institute of Psychiatry, Rawalpindi, Pakistan
First posted: 2020-02-05
Enrollment: 160
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm, single blind individual randomized controlled trial (RCT)
Primary purpose: TREATMENT

Brief summary: Background: Increasing prevalence rates of developmental disorders (DDs) including Autism Spectrum Disorders (ASD) and intellectual disability are a public health priority particularly in Low and Middle Income countries (LIMC) and are included in the World Health Organization (WHO) mhGAP program. However, existing mental health care facilities and resources are insufficient in most low resource settings to cater for this increasing demand. To address this situation, Caregiver Skills Training (CST) program for children with developmental disorders and delays has been developed by the WHO to bridge the treatment gap in low resource settings.

Objective: The objective of this study is 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 a low-resource rural community settings of Rawalpindi, Pakistan.

Methods: A two arm, single blind individual randomized controlled trial (RCT) will be carried out with 160 caregiver-child dyads with development disorders and delays in community settings of Rawalpindi, Pakistan. 160 caregiver-child dyads will be individually randomized on 1:1 allocation ratio into intervention (n=80) and control (n=80) arms. Participants in the intervention arm will receive 3-hours group training sessions of WHO CST program once every week for 9 weeks and 3 individual home sessions delivered via non-specialist health care facilitator over a duration of 3-months. The primary outcome is improvement in play-based caregiver-child interaction at 9-months post-intervention. The secondary outcomes are improvement in routine home-based caregiver-child interaction, child's social communication skills, adaptive behavior, emotional and behavioral problems and parental health related quality of life. The data on health services utilization will also be collected at 9-months post-intervention. Qualitative process evaluation with a sub-sample of study participants and trainers will be undertaken following the RCT. The study will be completed within an estimated period of 11-months.

Discussion: Outcomes of the study will be the evidence on the effectiveness of WHO CST program to improve caregiver child interaction and improvement in social communication skills, adaptive behaviors of children with developmental disorders and delays in the low resource setting of Pakistan.


Eligibility criteria: Inclusion Criteria:

* Children aged 2-9 years old, with developmental disorders and delays as screened by TQS
* Screened positive on communication problems as identified by Communication and Symbolic Behavior Scale (CSBS) score \<41
* Developmental Disability-Children's Global Assessment Scale (DD-CGAS) score ≥ 51 as assessed by clinician.

Exclusion Criteria:

* Children having epilepsy with seizures in the previous 6 months
* Children with Cerebral Palsy as assessed by the clinician.
* Co-morbid physical and mental conditions in the child that require inpatient hospitalization.
* Significant uncorrected hearing and visual impairment in child or parent.
* Any severe psychiatric or physical illness in primary caregiver requiring inpatient hospitalization.

Primary outcomes:
measure: Play-based caregiver-child interaction
timeFrame: 9-months post-intervention
Secondary outcomes:
measure: Adaptive functioning behaviors
timeFrame: At baseline, 9-weeks and 9-months post-intervention follow-up.
measure: Child emotional and behavioral problems
timeFrame: At baseline, 9-weeks and 9-months post-intervention follow-up.
measure: Parental health related quality of life
timeFrame: At baseline, 9-weeks and 9-months post-intervention follow-up.
measure: Health services utilization
timeFrame: At baseline and 9-months post-intervention follow-up.
measure: Communication and Symbolic Behavior
timeFrame: Screening, 9-weeks & 9-months post-intervention follow-up.
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Human Development Research Foundation
Study officials:
affiliation: Human Development Research Foundation, Pakistan
name: Syed Usman Hamdani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: mhGAP Intervention Guide for Mental, Neurological and Substance Use Disorders in Non-Specialized Health Settings: Mental Health Gap Action Programme (mhGAP). Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138690/
citation: Chisholm D, Knapp MR, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B. Client Socio-Demographic and Service Receipt Inventory--European Version: development of an instrument for international research. EPSILON Study 5. European Psychiatric Services: Inputs Linked to Outcome Domains and Needs. Br J Psychiatry Suppl. 2000;(39):s28-33. doi: 10.1192/bjp.177.39.s28.
citation: Wetherby, A.M. and B.M. Prizant, Communication and symbolic behavior scales (CSBS). 2003: Brookes Publishing Company.
citation: Sparrow SS, Cicchetti DV. Diagnostic uses of the Vineland Adaptive Behavior Scales. J Pediatr Psychol. 1985 Jun;10(2):215-25. doi: 10.1093/jpepsy/10.2.215. No abstract available.
citation: Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39. doi: 10.1097/00005650-199902000-00003.