Effectiveness of the WHO Caregivers Skills Training Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-11

Study Completion Date

2021-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Coping Effectiveness Training Intervention for Caregivers of Children With Autism Spectrum: A Feasibility Study

NCT01168284

Autism Spectrum Disorders

COMPLETED NA

A Common Elements-based Intervention to Improve Maternal Psychological Well-being and Mother-infant Interaction

NCT04252807

Maternal Distress Perinatal Depression Development Delay +9 more

COMPLETED NA

Caregiver Skills Training: Comparing Clinician Training Methods

NCT06038799

Parenting

TERMINATED NA

Effects of Virtual Discrete Trial Training on Children With Autism Spectrum Disorder

NCT06522490

Autism Spectrum Disorder

COMPLETED NA

Testing Scalable Caregiver Interventions for Autism

NCT07259044

Autism Spectrum Disorder Autism ASD

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arm, single blind individual randomized controlled trial (RCT)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

WHO caregiver skills training program

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

Group Type EXPERIMENTAL

WHO Caregiver skills training (CST) program

Intervention Type BEHAVIORAL

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.

Treatment as usual (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.

Group Type EXPERIMENTAL

Treatment as usual

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

WHO Caregiver skills training (CST) program

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.

Intervention Type BEHAVIORAL

Treatment as usual

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No