RCT of SCERTS (Social Communication, Emotional Regulation, Transactional Support) Program for Children With Autism Spectrum Disorder

NCT06733324 | Active Not Recruiting DMC

• 1 other identifier: RC-EA-2024/265
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Autism Spectrum Disorder (ASD

Keywords

Autism Spectrum Disorder; SCERTS; Parental Distress; Quality of Life; Adaptive Behavior

Outcome Measures

Primary Outcomes (1)

• SCERTS Assessment Process

  Social Communication, Emotional Regulation and Transactional Support

  3 months

Secondary Outcomes (3)

• Developmental Disorders-Children Disability Assessment Schedule (DD-CDAS)

  3 to 4 months

• WHO Quality of Life Scale

  3 months

• Perceived Stress Scale

  3 months

Study Arms (2)

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.

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.

Behavioral: Behavioral Treatment, Speech Therapy

Interventions

SCERTS (Social Communication, Emotional Regulation, Transactional Support) BEHAVIORAL

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

Participants will receive SCERTS intervention

Behavioral Treatment, Speech Therapy BEHAVIORAL

The control group will be the treatment as usual group receiving conventional behavior therapy and speech therapy

Control Group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age-3 to 6 years
• Diagnosis- Mild and Moderate ASD (Based on the score of Childhood Autism Rating Scale)

You may not qualify if:

• Age less than 3 or more than 6
• Diagnosis: Severe Autism Spectrum Disorder, Any other neurodevelopmental disorder

Sponsors & Collaborators

• Aisha Saleem: lead
• Ayub Medical College, Abbottabad: collaborator

Study Sites (1)

Ayub Medical College and Teaching Hospital

Abbottabad, KPK, 22010, Pakistan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Behavior Therapy; Speech Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Psychologist & Lecturer

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)