Clinical trial NCT06733324: RCT of SCERTS (Social Communication, Emotional Regulation, Transactional Support) Program for Children With Autism Spectrum Disorder
Official title: Randomized Control Trial of SCERTS (Social Communication, Emotional Regulation, Transactional Support) Program for Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder (ASD
Keywords: Autism Spectrum Disorder
SCERTS
Parental Distress
Quality of Life
Adaptive Behavior
Lead sponsor: National University of Science and Technology, Pakistan
Sponsor class: OTHER
Collaborators: name: Ayub Medical College, Abbottabad
First posted: 2024-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

1. To translate and validate the outcome measures for the evaluation of the program.
2. 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.
3. To translate and culturally adapt the SCERTS Intervention Program and establish its cultural equivalence to make it suitable for Pakistani culture.
4. 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.
5. 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.
6. 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:

1. Children with ASD who receive the SCERTS Intervention will demonstrate significant improvement in social communication skills as compared to treatment as usual group.
2. Children with ASD who receive the SCERTS program will demonstrate significant improvement in adaptive behavior as compared to TAU Group.
3. Parents and caregivers of children with ASD who participate in SCERTS intervention will report significantly higher quality of life as compared to TAU Group.
4. Parents and caregivers of children with ASD who participated in SCERTS intervention will demonstrate significant reduction in caregiver stress as compared to TAU group.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: SCERTS Assessment Process
timeFrame: 3 months
Secondary outcomes:
measure: Developmental Disorders-Children Disability Assessment Schedule (DD-CDAS)
timeFrame: 3 to 4 months
measure: WHO Quality of Life Scale
timeFrame: 3 months
measure: Perceived Stress Scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Abbottabad
country: Pakistan
facility: Ayub Medical College and Teaching Hospital
state: KPK
Study officials:
References: