Effectiveness of the WHO Caregivers Skills Training Program
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2019
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
February 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedFebruary 25, 2020
February 1, 2020
11 months
September 14, 2019
February 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Play-based caregiver-child interaction
The primary outcome will be change in play-based caregiver-child interaction using Joint Engagement Rating Inventory. An observational, video rated tool will be used to rate caregivers-child's engagement and behavior during play and home routine following a communication play protocol on a 7-point Likert scale The tool has been adapted for coding. caregivers' child interaction in the context of Pakistan. Fifteen-minute video taped caregiver-child interaction will be collected at baseline and at endpoint for families in both arms of the study. Caregivers will be asked to try play based routines (e.g. playing with toys or reading a book) with their child or home routines involving the child (e.g. feeding the child performing domestic chores). The videos will be singly coded by trained assessors.
9-months post-intervention
Secondary Outcomes (5)
Adaptive functioning behaviors
At baseline, 9-weeks and 9-months post-intervention follow-up.
Child emotional and behavioral problems
At baseline, 9-weeks and 9-months post-intervention follow-up.
Parental health related quality of life
At baseline, 9-weeks and 9-months post-intervention follow-up.
Health services utilization
At baseline and 9-months post-intervention follow-up.
Communication and Symbolic Behavior
Screening, 9-weeks & 9-months post-intervention follow-up.
Study Arms (2)
WHO caregiver skills training program
EXPERIMENTALStrategies to support children's communication skills by learning to engage in play activities and daily home routines activities with their caregivers.
Treatment as usual (TAU)
EXPERIMENTALTAU in primary healthcare centers for childhood developmental disorders and delays usually consists of no treatment, or a range of alternate treatment regimes, such as multi-vitamin syrups and tablets.
Interventions
Caregivers are provided with tangible strategies to appropriately respond to their children's emotional regulation, engagement, and communication. Further, the program focuses on helping caregivers to develop their children's communication and adaptive skills while reducing challenging behavior by focusing on identifying the function of the behavior and learning to teach developmentally appropriate replacement skills. The WHO CST program includes nine group sessions delivered at a community venue (e.g., BHU, 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. Training for program facilitators will be included prior to the delivery of the intervention.
WHO CST will be compared with TAU. TAU in primary healthcare centers for childhood developmental disorders and delays usually consists of no treatment, or a range of alternate treatment regimes, such as multi-vitamin syrups and tablets. Evidence-based mental health care is currently not available in primary healthcare centers. A complete record of services availed by the trial participants at tertiary mental healthcare center will be maintained by using an adapted Client Services Receipt Inventory (CSRI) for children with developmental disorders and delays at baseline and end point.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Human Development Research Foundation, Pakistanlead
- World Health Organizationcollaborator
- University of Liverpoolcollaborator
- Benazir Bhutto Hospital, Rawalpindicollaborator
Study Sites (1)
Human Development Research Foundation
Islamabad, Pakistan
Related Publications (5)
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/
PMID: 23741783BACKGROUNDChisholm 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.
PMID: 10945075BACKGROUNDWetherby, A.M. and B.M. Prizant, Communication and symbolic behavior scales (CSBS). 2003: Brookes Publishing Company.
BACKGROUNDSparrow 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.
PMID: 4020603BACKGROUNDVarni 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.
PMID: 10024117BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Syed Usman Hamdani, PhD
Human Development Research Foundation, Pakistan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors will be blind to the allocations status of participants. To ensure blinding, participants will be instructed to not disclose their allocation during assessment. Fidelity of masking will be ensured by having assessors guess the allocation status of participants at the end of assessments.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2019
First Posted
February 5, 2020
Study Start
February 11, 2020
Primary Completion
December 31, 2020
Study Completion
January 31, 2021
Last Updated
February 25, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share