Effectiveness of the WHO Caregivers Skills Training Program

Human Development Research Foundation, Pakistan

Status: Unknown

Conditions: Development Delay; Maternal Distress; Autism Spectrum Disorder; Emotional Problem; Behavioral Problem; Developmental Disorder; Language Delay

Treatments: Behavioral: Treatment as usual; Behavioral: WHO Caregiver skills training (CST) program

Study type: Interventional

Funder types: Other

Identifiers

NCT04255472

WHO CST-RCT

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 2 to 9 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

WHO caregiver skills training program

Experimental group

Description:

Strategies to support children's communication skills by learning to engage in play activities and daily home routines activities with their caregivers.

Treatment:

Behavioral: WHO Caregiver skills training (CST) program

Treatment as usual (TAU)

Experimental group

Description:

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.

Treatment:

Behavioral: Treatment as usual