Testing a culturally tailored online training program to help parents and caregivers manage challenging behaviors in autistic children at home
| ISRCTN | ISRCTN48518719 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48518719 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | NRPU 17141 |
| Sponsors | Foundation University Islamabad, Pakistan Institute of Learning and Living |
| Funder | Higher Education Commision, Pakistan |
- Submission date
- 07/09/2024
- Registration date
- 18/09/2024
- Last edited
- 21/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Many children with autism experience challenging behaviors, such as tantrums and aggression, which can make daily life difficult and impact their ability to interact with others. These behaviors can also cause significant stress, anxiety, and depression in parents and caregivers. In Pakistan, around 400,000 children are affected by autism, and there are limited resources available to help families manage these challenges. This study aims to test a new training program for parents and caregivers of children with autism to help them better manage challenging behaviors. The program is designed to be delivered online (via telehealth) to make it accessible to families across Pakistan.
Who can participate?
Parents or primary caregivers of children aged 2 to 16 years who have been diagnosed with autism and have internet access for video conferencing can participate.
What does the study involve?
If you decide to participate, you will first be provided with detailed information about the study, including potential benefits and risks, and asked to give your consent. Then, all participants will complete an initial assessment. Participants will be randomly assigned to either a group receiving the online training program or a control group. After all sessions are completed, a follow-up assessment will be conducted to measure the impact of the training.
What are the possible benefits and risks of participating?
Since this is a behavioral training program, there are no expected risks or harms from participating. The possible benefits include learning new strategies to help manage your child’s behaviors more effectively.
Where is the study run from?
Foundation University Islamabad
Pakistan Institute of Learning and Living
When is the study starting and how long is it expected to run for?
September 2022 to May 2025
Who is funding the study?
Higher Education Commission of Pakistan
Who is the main contact?
Dr Nadia Shafique, nadiashafique17@gmail.com
Dr Sawera Mansoor, sawera.mansoor@fui.edu.pk
Contact information
Public, Scientific, Principal investigator
Visiting Researcher Department of Psychology, University of Washington, USA.
Assistant Professor Department of Psychology Foundation University Islamabad
Washington
98109
United States of America
| Phone | +1 (425) 525-8418 |
|---|---|
| nadiashafique17@gmail.com |
Principal investigator
Department of Psychiatry, Foundation University Medical College
Islamabad
44000
Pakistan
 ORCID ID |
0009-0009-5522-7206 |
|---|---|
| Phone | +92 3335129156 |
| sawera.mansoor@fui.edu.pk |
Scientific
Suite # 201, 2nd Floor, The Plaza, Do-Talwar, Khayaban-e-Iqbal, Clifton
Karachi
59201
Pakistan
| Phone | +92 21 35871845 |
|---|---|
| nasim.chaudhry@pill.org.pk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Feasibility randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | ISRCTN48518719 Participant Information Sheet C-TEACH study.pdf |
| Scientific title | A feasibility randomized controlled trial for evaluating the Culturally adapted Telehealth Empowering program for parents/caregivers to Address Challenging behaviors of autistic children at Home (C-TEACH) |
| Study acronym | C-TEACH |
| Study objectives | A culturally adapted parent-mediated telehealth training will be feasible and acceptable to deliver among parents in Pakistan while improving the adaptive behaviors of their children, reducing parental burnout, and improving parental self-efficacy in parents of children with Autism in Pakistan. |
| Ethics approval(s) |
Approved 08/09/2022, Foundation University Islamabad (New Lalazar, Rawalpindi, 44000, Pakistan; +92 515151433; info.fusst@fui.edu.pk), ref: FURC/IRB/Spring-2022/48 |
| Health condition(s) or problem(s) studied | Challenging behaviors in children with autism |
| Intervention | All recruited participants who screen positive (Score on Aberrant behavior checklist-Irritability scale greater than 15) will be included after obtaining informed consent. They will be randomized into 2 groups through an online tool (computer generated randomization table) Group 1 (Parent Intervention): This group will receive a Culturally Adapted Telehealth Parent-Mediated Training, which is based on the RUBI parent training manual to manage disruptive behaviours in children with Autism and includes an additional mindfulness component modified from Compassion focused therapy to address parental distress. This intervention will comprise of 12 sessions (each session lasting 90 minutes), delivered once a week in a group format, online. The focus will be on teaching the ABC model to parents, providing strategies to implement appropriate responses such as positive reinforcement, planned ignoring, and compliance training along with teaching essential life skills. The goals are improved adaptive skills and decreased maladaptive behaviors in children with Autism, and reduced parental burnout using Mindfulness based stress management. Group 2 (Parent Education): The other group will receive parent education sessions (as the control group) in a group format once a week for 12 weeks. Each session will last for 90 minutes and focus on general principles of counselling related to care and behavioural management of children with Autism. In both groups, the sessions will be conducted by relevant qualified professionals. Baseline assessments will be done pre intervention, followed by a final post intervention assessment at the end of 12 weeks. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Challenging/Disruptive behaviors in children will be measured using the Aberrant Behavior Checklist irritability subscale at baseline and post-intervention |
| Key secondary outcome measure(s) |
1. Parental burnout will be assessed using Parental Burnout Assessment at baseline and post-intervention |
| Completion date | 31/05/2025 |
Eligibility
| Participant type(s) | Carer |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Parents of children aged 2-16 years with a diagnosis of Autism Spectrum Disorder 2. Behavioral difficulties measured as a score 15 or more on the Irritability sub-scale of Aberrant Behavior Checklist-Community (ABC-C) 3. Participant is a parent or primary caregiver of child 4. Having access to internet and an electronic device to attend online sessions |
| Key exclusion criteria | 1. Any physical disability such as hearing impairment, blindness in parent 2. Any medical condition in parent like pregnancy or any chronic disease 3. Not having the resources to do video-conference calls 4. Parents who have received any intensive parent training during the past 12 months |
| Date of first enrolment | 10/06/2024 |
| Date of final enrolment | 31/01/2025 |
Locations
Countries of recruitment
- Pakistan
Study participating centres
Islamabad
44000
Pakistan
Rawalpindi
46000
Pakistan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository, Data sharing statement to be made available at a later date |
| IPD sharing plan | To ensure the scientific integrity of the study, participant data will not be shared or disclosed for publication or oral presentations before the trial concludes, unless authorized by the Principal Investigator. The full data-sharing plan will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 21/01/2025 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN48518719 Participant Information Sheet C-TEACH study.pdf
- Participant information sheet
Editorial Notes
21/01/2025: The participant information sheet was uploaded as an additional file.
16/12/2024: The following changes were made to the trial record:
1. The overall end date was changed from 30/05/2025 to 31/05/2025.
2. The recruitment end date was changed from 30/12/2024 to 31/01/2025.
3. The participant level data sharing statement was added.
09/09/2024: Trial's existence confirmed by Higher Education Commission
