Autism Spectrum DisorderNCT04255472
Effectiveness of the WHO Caregivers Skills Training Program
A study testing WHO Caregiver skills training (CST) program and Treatment as usual in people with Autism Spectrum Disorder and Development Delay, run by Human Development Research Foundation, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 9 years
- Conditions the study is for
- Autism Spectrum Disorder, Development Delay, Developmental Disorder
- What is being tested?
- WHO Caregiver skills training (CST) program and Treatment as usual
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Feb 2020to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Human Development Research Foundation
Islamabad
Syed Usman Hamdani, MBBS, PhD, +92 51 265 6172, usman.hamdani@hdrfoundation.org
About this study
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)
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.
Read more
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.
- Conditions
- Autism Spectrum Disorder, Development Delay, Developmental Disorder, Language Delay, Behavioral Problem, Emotional Problem
- Being tested
- WHO Caregiver skills training (CST) program, Treatment as usual
- Medical subject headings
- Autism Spectrum Disorder, Learning Disabilities, Developmental Disabilities, Language Development Disorders, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO Caregiver skills training (CST) programBehavioural
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 usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| WHO caregiver skills training program | Experimental | Strategies to support children's communication skills by learning to engage in play activities and daily home routines activities with their caregivers. Receives: Behavioral: WHO Caregiver skills training (CST) program |
| Treatment as usual (TAU) | Experimental | 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. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9-months post-intervention
Secondary outcomes (5)
Adaptive functioning behaviors
Vineland Adaptive Behavior Scales (VABS) will be used to measure adaptive behaviors. VABS will be used to measure child's functioning in the area of communication, daily living skills, socialization and motor skills. The VABS contains 5 domains each with 2-3 subdomains. The main domains are Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior (optional). There are five general categories of answers for each item. These are "Usually Performs", "Sometimes Perform", "Never Performs", Never had the opportunity to perform" and "Don't know or never observed the child to perform".
Measured: At baseline, 9-weeks and 9-months post-intervention follow-up.
Child emotional and behavioral problems
Child emotional and behavioral problems will be measured through Child Behavior Checklist (CBCL). It consists of 113 questions, scored on a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). CBCL is made up of eight syndrome scales: anxious/depressed, depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior, and aggressive behavior.
Measured: At baseline, 9-weeks and 9-months post-intervention follow-up.
Parental health related quality of life
Parental health related quality of life will be measured by Pediatric Quality of Life (PedsQL) Family impact module. It is a 36 items impact module scale that consisting of 6 sub-scales measuring parent self-reported functioning. These subscales measure physical functioning, emotional functioning, social functioning, daily activities and family relationships. Items are rated on a 5-point Likert scale (0 = never to 4= almost always) and add up to 100 score, where higher scores indicate better Health Related Quality of Life.
Measured: At baseline, 9-weeks and 9-months post-intervention follow-up.
Health services utilization
The cost of health services utilization from the time proceeding assessment will be assessed with the adapted Client Services Receipt Inventory (CSRI). It has been adapted to use for the families of children with developmental disorders and delays. It measures the utilization of various health and social care services including time and opportunity losses by the families in the care of their child with developmental disorder and delay.
Measured: At baseline and 9-months post-intervention follow-up.
Communication and Symbolic Behavior
Communication and Symbolic Behavior Scale will be used as a screening tool to identify children with delay in social communication, expressive speech/language, and symbolic functioning, as well as a secondary outcome measures to determine the impact of intervention overtime. CSBS measures 7 language predictors: emotion and eye gaze, communication, gestures, sounds, words, understanding, and object use. CSBS caregiver questionnaire consists of 41 items divided into seven clusters which make three composites i.e. social composite, speech composite and symbolic composite. Items are rated on 3-point Likert scale: "Not Yet/Rarely", "Sometimes" and "Often/Usually".
Measured: Screening, 9-weeks & 9-months post-intervention follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start11 Feb 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm, single blind individual randomized controlled trial (RCT)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Human Development Research Foundation, Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, University of Liverpool, Benazir Bhutto Hospital, Rawalpindi
- Responsible party
- Sponsor
- Investigators
- Syed Usman Hamdani, PhD, Principal investigator, Human Development Research Foundation, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255472
- Sponsor's protocol ID
- WHO CST-RCT
- Status last verified
- Feb 2020
- First submitted
- 14 Sep 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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/
PubMed 23741783Chisholm 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.
PubMed 10945075Wetherby, A.M. and B.M. Prizant, Communication and symbolic behavior scales (CSBS). 2003: Brookes Publishing Company.
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.
PubMed 4020603Varni 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.
PubMed 10024117
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04255472
- Acronym / sponsor ID
- WHO CST-RCT
- Conditions
- Autism Spectrum Disorder, Development Delay, Developmental Disorder, Language Delay, Behavioral Problem, Emotional Problem
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Human Development Research Foundation, PakistanUniversity, hospital or other
- Collaborators
- World Health Organization, University of Liverpool, Benazir Bhutto Hospital, Rawalpindi
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arm, single blind individual randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| WHO caregiver skills training program | Experimental | Behavioral: WHO Caregiver skills training (CST) programStrategies 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) | Experimental | Behavioral: Treatment as usualTAU 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. |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHO Caregiver skills training (CST) programCaregivers 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. | Behavioural | WHO caregiver skills training program |
| Treatment as usualWHO 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. | Behavioural | Treatment as usual (TAU) |
Primary outcome
Play-based caregiver-child interaction
Time frame: 9-months post-intervention
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.
5 secondary outcomes
Adaptive functioning behaviors
Time frame: At baseline, 9-weeks and 9-months post-intervention follow-up.
Child emotional and behavioral problems
Time frame: At baseline, 9-weeks and 9-months post-intervention follow-up.
Parental health related quality of life
Time frame: At baseline, 9-weeks and 9-months post-intervention follow-up.
Health services utilization
Time frame: At baseline and 9-months post-intervention follow-up.
Communication and Symbolic Behavior
Time frame: Screening, 9-weeks & 9-months post-intervention follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 23741783mhGAP 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/
- Background: PubMed 10945075Chisholm 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.
- BackgroundWetherby, A.M. and B.M. Prizant, Communication and symbolic behavior scales (CSBS). 2003: Brookes Publishing Company.
- Background: PubMed 4020603Sparrow 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.
- Background: PubMed 10024117Varni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed Usman Hamdani, PhD principal investigator
Human Development Research Foundation, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHO Caregiver skills training (CST) program and Treatment as usual in people with Autism Spectrum Disorder and Development Delay, run by Human Development Research Foundation, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Syed Usman Hamdani, PhD (0092 512656172, usman.hamdani@hdrfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Play-based caregiver-child interaction (time frame: 9-months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04255472, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.