Autism Spectrum Disorder (ASDNCT06733324
RCT of SCERTS (Social Communication, Emotional Regulation, Transactional Support) Program for Children With Autism Spectrum Disorder
A study testing SCERTS (Social Communication, Emotional Regulation, Transactional Support) and Behavioral Treatment, Speech Therapy in people with Autism Spectrum Disorder (ASD, run by Aisha Saleem at 1 site in Pakistan.
Trial summary
This randomized control trial aims to assess the efficacy of the SCERTS intervention in children aged 3-6 years diagnosed with mild to moderate Autism Spectrum Disorder (ASD). The study evaluates the program's impact on improving social communication skills, adaptive behavior, and reducing caregiver stress while… Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD
- What is being tested?
- SCERTS (Social Communication, Emotional Regulation, Transactional Support) and Behavioral Treatment, Speech Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2025to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age-3 to 6 years
- Diagnosis- Mild and Moderate ASD (Based on the score of Childhood Autism Rating Scale)
Who cannot join
- Age less than 3 or more than 6
- Diagnosis: Severe Autism Spectrum Disorder, Any other neurodevelopmental disorder
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ayub Medical College and Teaching Hospital
Abbottabad, KPK, 22010
About this study
Official title: Randomized Control Trial of SCERTS (Social Communication, Emotional Regulation, Transactional Support) Program for Children With Autism Spectrum Disorder
This randomized control trial aims to assess the efficacy of the SCERTS intervention in children aged 3-6 years diagnosed with mild to moderate Autism Spectrum Disorder (ASD). The study evaluates the program's impact on improving social communication skills, adaptive behavior, and reducing caregiver stress while enhancing parental quality of life. The intervention incorporates components of Social Communication, Emotional Regulation, and Transactional Support, tailored to cultural and contextual needs in Pakistan. The study will also validate translated and culturally adapted tools for program evaluation.
The SCERTS model is a multidisciplinary, evidence-based intervention that focuses on enhancing social communication, emotional regulation, and providing transactional support in children with ASD. This 8-week program will be tested through a single-blind randomized trial, with participants assigned to an experimental group or a waitlist control group. Outcomes include joint attention, imitation, emotional sharing, and intentional communication. The study will also evaluate the intervention's feasibility, fidelity, and acceptability in the Pakistani context. Post-intervention assessments and follow-ups will determine long-term benefits.
Read the detailed description
This study is a single-blind, randomized controlled trial to evaluate the efficacy of the SCERTS (Social Communication, Emotional Regulation, Transactional Support) intervention for children with Autism Spectrum Disorder (ASD) aged 3 to 6 years. ASD is a neurodevelopmental disorder with increasing prevalence worldwide and in Pakistan, where it remains underdiagnosed and underserved. This study aims to address gaps in autism care by culturally adapting and implementing the SCERTS model in a resource-constrained setting.
The SCERTS intervention focuses on three core components: improving Social Communication (e.g., joint attention, reciprocal interaction), enhancing Emotional Regulation (e.g., coping with stress, self-regulation), and fostering Transactional Support (e.g., creating supportive environments through caregiver involvement). This family-centered approach empowers parents and teachers to implement strategies in natural settings, reducing caregiver stress while promoting child development.
The trial will enroll 30 participants, divided into an experimental group receiving the SCERTS intervention and a waitlist control group receiving standard care. The intervention spans 8 weeks, with weekly sessions involving individualized and group activities tailored to the child's developmental level and cultural context. Outcome measures include social communication skills, adaptive behaviors, caregiver stress, and quality of life, assessed using validated, culturally adapted tools.
This trial adheres to the Medical Research Council Framework for complex interventions and follows CONSORT guidelines for feasibility studies. The findings are expected to provide evidence for the effectiveness and scalability of the SCERTS model in low-resource settings, contributing to improved care and outcomes for children with ASD and their families in Pakistan.
This description is clear, comprehensive, and aligns with ClinicalTrials.gov requirements. It highlights the purpose, design, methodology, and expected significance of the study.
The main objectives of the study are:
- To translate and validate the outcome measures for the evaluation of the program.
- To determine the fidelity, feasibility and acceptability of implementing the SCERTS intervention in Pakistani culture, including participant recruitment, intervention delivery, and adherence to the intervention protocol.
- To translate and culturally adapt the SCERTS Intervention Program and establish its cultural equivalence to make it suitable for Pakistani culture.
- To assess the efficacy of the Social Communication, Emotional Regulation, and Transactional Support (SCERTS) intervention compared to standard care in improving social communication skills among children diagnosed with Autism Spectrum Disorder (ASD) aged between 3 to 6 years.
- To investigate the effectiveness of the SCERTS intervention in promoting adaptive behaviors and functional outcomes in children with ASD aged between 3 to 6 years, as measured by standardized assessment tools.
- To assess the maintenance of intervention effects over time through follow-up assessments conducted at specified intervals post-intervention.
The hypotheses of the study are:
- Children with ASD who receive the SCERTS Intervention will demonstrate significant improvement in social communication skills as compared to treatment as usual group.
- Children with ASD who receive the SCERTS program will demonstrate significant improvement in adaptive behavior as compared to TAU Group.
- Parents and caregivers of children with ASD who participate in SCERTS intervention will report significantly higher quality of life as compared to TAU Group.
- Parents and caregivers of children with ASD who participated in SCERTS intervention will demonstrate significant reduction in caregiver stress as compared to TAU group.
- Conditions
- Autism Spectrum Disorder (ASD
- Being tested
- SCERTS (Social Communication, Emotional Regulation, Transactional Support), Behavioral Treatment, Speech Therapy
- Keywords
- Autism Spectrum Disorder, SCERTS, Parental Distress, Quality of Life, Adaptive Behavior
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCERTS (Social Communication, Emotional Regulation, Transactional Support)Behavioural
The SCERTS (Social Communication, Emotional Regulation, and Transactional Support) intervention is a comprehensive, multidisciplinary approach specifically tailored to address the unique needs of children with Autism Spectrum Disorder (ASD) aged 3-6 years. Unlike traditional behavioral therapies such as Applied Behavior Analysis (ABA), SCERTS emphasizes a developmental framework, focusing on enhancing social communication, emotional regulation, and environmental support. It incorporates family involvement and integrates strategies into naturalistic settings, ensuring skill generalization across home, school, and community environments.
This intervention is distinguished by its individualized goals based on each child's developmental profile and its emphasis on fostering meaningful interactions rather than relying on compliance-based methods. SCERTS also incorporates transactional supports, such as modifying the physical and social environment to promote engagement and reduce stress, w
Behavioral Treatment, Speech TherapyBehavioural
The control group will be the treatment as usual group receiving conventional behavior therapy and speech therapy
| Study group | Role | What they receive |
|---|---|---|
| Participants will receive SCERTS intervention | Experimental | Participants in the experimental group will receive the SCERTS (Social Communication, Emotional Regulation, and Transactional Support) intervention program. This is an evidence-based, individualized program designed to improve social communication, emotional regulation, and adaptive behaviors in children with Autism Spectrum Disorder (ASD) aged 3-6 years. The intervention will be delivered over 8 weeks, with weekly structured sessions involving parents and educators to ensure skill generalization across home and school settings. The program includes strategies to enhance joint attention, emotion sharing, symbolic play, and the use of non-verbal cues. Parents will be actively engaged to facilitate ongoing support and reinforcement in real-life environments. Receives: Behavioral: SCERTS (Social Communication, Emotional Regulation, Transactional Support) |
| Control Group | Active comparator | Participants in the treatment-as-usual (TAU) group will receive the standard care typically available for children with Autism Spectrum Disorder (ASD) in the community. This may include therapies such as speech-language therapy, occupational therapy, and applied behavior analysis, depending on the availability of services and individual needs. These interventions focus on addressing core ASD symptoms like communication deficits, behavioral challenges, and sensory integration difficulties. The TAU group will not receive any components of the SCERTS intervention during the study period. This group will serve as an active comparator to evaluate the relative effectiveness of the SCERTS program in improving social communication, emotional regulation, and adaptive behaviors. After the study concludes, participants in the TAU group will have the opportunity to receive the SCERTS intervention to ensure equitable access to the experimental treatment. Receives: Behavioral: Behavioral Treatment, Speech Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCERTS Assessment Process
Social Communication, Emotional Regulation and Transactional Support
Measured: 3 months
Secondary outcomes (3)
Developmental Disorders-Children Disability Assessment Schedule (DD-CDAS)
Addresses various domains of adaptive behavior skills
Measured: 3 to 4 months
WHO Quality of Life Scale
To assess the overall quality of life of the family
Measured: 3 months
Perceived Stress Scale
To measure to level of stress in primary caregivers
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start1 Jun 2025
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASDStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aisha Saleem
- Sponsor type
- University, hospital or other
- Collaborators
- Ayub Medical College, Abbottabad
- Responsible party
- Sponsor-investigator, Aisha Saleem, National University of Science and Technology, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733324
- Sponsor's protocol ID
- RC-EA-2024/265
- Status last verified
- Apr 2026
- First submitted
- 10 Dec 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Keeping in view the confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of SCERTS (Social Communication, Emotional Regulation, Transactional Support) Program for Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06733324
- Acronym / sponsor ID
- RC-EA-2024/265
- Conditions
- Autism Spectrum Disorder (ASD
- Keywords
- Autism Spectrum Disorder, SCERTS, Parental Distress, Quality of Life, Adaptive Behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aisha SaleemUniversity, hospital or other
- Collaborators
- Ayub Medical College, Abbottabad
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 13 Dec 2024 (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.
This randomized control trial aims to assess the efficacy of the SCERTS intervention in children aged 3-6 years diagnosed with mild to moderate Autism Spectrum Disorder (ASD). The study evaluates the program's impact on improving social communication skills, adaptive behavior, and reducing caregiver stress while enhancing parental quality of life. The intervention incorporates components of Social Communication, Emotional Regulation, and Transactional Support, tailored to cultural and contextual needs in Pakistan. The study will also validate translated and culturally adapted tools for program evaluation.
The SCERTS model is a multidisciplinary, evidence-based intervention that focuses on enhancing social communication, emotional regulation, and providing transactional support in children with ASD. This 8-week program will be tested through a single-blind randomized trial, with participants assigned to an experimental group or a waitlist control group. Outcomes include joint attention, imitation, emotional sharing, and intentional communication. The study will also evaluate the intervention's feasibility, fidelity, and acceptability in the Pakistani context. Post-intervention assessments and follow-ups will determine long-term benefits.
Detailed description
This study is a single-blind, randomized controlled trial to evaluate the efficacy of the SCERTS (Social Communication, Emotional Regulation, Transactional Support) intervention for children with Autism Spectrum Disorder (ASD) aged 3 to 6 years. ASD is a neurodevelopmental disorder with increasing prevalence worldwide and in Pakistan, where it remains underdiagnosed and underserved. This study aims to address gaps in autism care by culturally adapting and implementing the SCERTS model in a resource-constrained setting.
The SCERTS intervention focuses on three core components: improving Social Communication (e.g., joint attention, reciprocal interaction), enhancing Emotional Regulation (e.g., coping with stress, self-regulation), and fostering Transactional Support (e.g., creating supportive environments through caregiver involvement). This family-centered approach empowers parents and teachers to implement strategies in natural settings, reducing caregiver stress while promoting child development.
The trial will enroll 30 participants, divided into an experimental group receiving the SCERTS intervention and a waitlist control group receiving standard care. The intervention spans 8 weeks, with weekly sessions involving individualized and group activities tailored to the child's developmental level and cultural context. Outcome measures include social communication skills, adaptive behaviors, caregiver stress, and quality of life, assessed using validated, culturally adapted tools.
This trial adheres to the Medical Research Council Framework for complex interventions and follows CONSORT guidelines for feasibility studies. The findings are expected to provide evidence for the effectiveness and scalability of the SCERTS model in low-resource settings, contributing to improved care and outcomes for children with ASD and their families in Pakistan.
This description is clear, comprehensive, and aligns with ClinicalTrials.gov requirements. It highlights the purpose, design, methodology, and expected significance of the study.
The main objectives of the study are:
- To translate and validate the outcome measures for the evaluation of the program.
- To determine the fidelity, feasibility and acceptability of implementing the SCERTS intervention in Pakistani culture, including participant recruitment, intervention delivery, and adherence to the intervention protocol.
- To translate and culturally adapt the SCERTS Intervention Program and establish its cultural equivalence to make it suitable for Pakistani culture.
- To assess the efficacy of the Social Communication, Emotional Regulation, and Transactional Support (SCERTS) intervention compared to standard care in improving social communication skills among children diagnosed with Autism Spectrum Disorder (ASD) aged between 3 to 6 years.
- To investigate the effectiveness of the SCERTS intervention in promoting adaptive behaviors and functional outcomes in children with ASD aged between 3 to 6 years, as measured by standardized assessment tools.
- To assess the maintenance of intervention effects over time through follow-up assessments conducted at specified intervals post-intervention.
The hypotheses of the study are:
- Children with ASD who receive the SCERTS Intervention will demonstrate significant improvement in social communication skills as compared to treatment as usual group.
- Children with ASD who receive the SCERTS program will demonstrate significant improvement in adaptive behavior as compared to TAU Group.
- Parents and caregivers of children with ASD who participate in SCERTS intervention will report significantly higher quality of life as compared to TAU Group.
- Parents and caregivers of children with ASD who participated in SCERTS intervention will demonstrate significant reduction in caregiver stress as compared to TAU group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants will receive SCERTS intervention | Experimental | Behavioral: SCERTS (Social Communication, Emotional Regulation, Transactional Support)Participants in the experimental group will receive the SCERTS (Social Communication, Emotional Regulation, and Transactional Support) intervention program. This is an evidence-based, individualized program designed to improve social communication, emotional regulation, and adaptive behaviors in children with Autism Spectrum Disorder (ASD) aged 3-6 years. The intervention will be delivered over 8 weeks, with weekly structured sessions involving parents and educators to ensure skill generalization across home and school settings. The program includes strategies to enhance joint attention, emotion sharing, symbolic play, and the use of non-verbal cues. Parents will be actively engaged to facilitate ongoing support and reinforcement in real-life environments. |
| Control Group | Active comparator | Behavioral: Behavioral Treatment, Speech TherapyParticipants in the treatment-as-usual (TAU) group will receive the standard care typically available for children with Autism Spectrum Disorder (ASD) in the community. This may include therapies such as speech-language therapy, occupational therapy, and applied behavior analysis, depending on the availability of services and individual needs. These interventions focus on addressing core ASD symptoms like communication deficits, behavioral challenges, and sensory integration difficulties. The TAU group will not receive any components of the SCERTS intervention during the study period. This group will serve as an active comparator to evaluate the relative effectiveness of the SCERTS program in improving social communication, emotional regulation, and adaptive behaviors. After the study concludes, participants in the TAU group will have the opportunity to receive the SCERTS intervention to ensure equitable access to the experimental treatment. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age-3 to 6 years
- Diagnosis- Mild and Moderate ASD (Based on the score of Childhood Autism Rating Scale)
Key exclusion criteria (2 listed)
- Age less than 3 or more than 6
- Diagnosis: Severe Autism Spectrum Disorder, Any other neurodevelopmental disorder
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 |
|---|---|---|
| SCERTS (Social Communication, Emotional Regulation, Transactional Support)The SCERTS (Social Communication, Emotional Regulation, and Transactional Support) intervention is a comprehensive, multidisciplinary approach specifically tailored to address the unique needs of children with Autism Spectrum Disorder (ASD) aged 3-6 years. Unlike traditional behavioral therapies such as Applied Behavior Analysis (ABA), SCERTS emphasizes a developmental framework, focusing on enhancing social communication, emotional regulation, and environmental support. It incorporates family involvement and integrates strategies into naturalistic settings, ensuring skill generalization across home, school, and community environments. This intervention is distinguished by its individualized goals based on each child's developmental profile and its emphasis on fostering meaningful interactions rather than relying on compliance-based methods. SCERTS also incorporates transactional supports, such as modifying the physical and social environment to promote engagement and reduce stress, w | Behavioural | Participants will receive SCERTS intervention |
| Behavioral Treatment, Speech TherapyThe control group will be the treatment as usual group receiving conventional behavior therapy and speech therapy | Behavioural | Control Group |
Primary outcome
SCERTS Assessment Process
Time frame: 3 months
Social Communication, Emotional Regulation and Transactional Support
3 secondary outcomes
Developmental Disorders-Children Disability Assessment Schedule (DD-CDAS)
Time frame: 3 to 4 months
WHO Quality of Life Scale
Time frame: 3 months
Perceived Stress Scale
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. Keeping in view the confidentiality
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCERTS (Social Communication, Emotional Regulation, Transactional Support) and Behavioral Treatment, Speech Therapy in people with Autism Spectrum Disorder (ASD, run by Aisha Saleem 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCERTS Assessment Process (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.