Comparative efficacy of family mediated intervention versus early intensive behavioural intervention on symptom domains in children with autism spectrum disorder: A randomized controlled trial

Rajeev Ranjan; Meha Jain; Muskan Sinha; Pankaj Kumar; Shamshad Ahmad; Vikas Maharshi

doi:10.1016/j.ajp.2024.104052

Comparative efficacy of family mediated intervention versus early intensive behavioural intervention on symptom domains in children with autism spectrum disorder: A randomized controlled trial

Asian J Psychiatr. 2024 Apr 16:96:104052. doi: 10.1016/j.ajp.2024.104052. Online ahead of print.

Authors

Rajeev Ranjan¹, Meha Jain², Muskan Sinha³, Pankaj Kumar⁴, Shamshad Ahmad⁵, Vikas Maharshi⁶

Affiliations

¹ Department of Psychiatry, All India Institute of Medical Sciences, Patna 801507, India. Electronic address: rajeevranjan0087@gmail.com.
² Department of Psychiatry, All India Institute of Medical Sciences, Patna 801507, India; Amity Institute of Clinical Psychology, Amity University, Jaipur-303002 India.
³ All India Institute of Medical Sciences, Patna 801507, India.
⁴ Department of Psychiatry, All India Institute of Medical Sciences, Patna 801507, India.
⁵ Department of Community & Family Medicine, All India Institute of Medical Sciences, Patna 801507, India.
⁶ Department of Pharmacology, All India Institute of Medical Sciences, Patna 801507, India.

PMID: 38688101
DOI: 10.1016/j.ajp.2024.104052

Abstract

Background: Family Mediated Intervention (FMI) and Early Intensive Behavioural Intervention (EIBI) are found to be standard of care for children with Autism Spectrum Disorder (ASD). Comparison of their efficacy were assessed using ISAA as primary outcome measure.

Methods: This study was a parallel arm, open label, randomized active- controlled non-inferiority clinical trial. 50 Children diagnosed with ASD were randomized into FMI and EIBI groups. Clinical status was checked by using Indian scale for assessment of autism (ISAA), Oro- motor and sensory profile at baseline, after three and six months.

Results: Difference between change in mean ISAA score between FMI and EIBI group at the end of 6 months as per protocol (PP) analysis was -7.23 (CI=-18.41, 3.94), which was within pre-defined clinically relevant non-inferiority (NI) margin of - 24. FMI was found to be non-inferior to EIBI at the end of 6 months as the lower bound of 95% CI (-18.41) for ISAA score was higher than NI margin. ISAA scores were found to be statistically lower in both FMI and EIBI groups at the end point compared to baseline which indicated improvement in symptom severity.

Conclusion: FMI was non-inferior to EIBI as therapy for children with ASD at the end of six months. Finding also indicated longer duration of treatment is required for FMI to be superior. FMI can be recommended for children with ASD in view of improved ISAA scores reported in our study.

Clinical trial registration number: CTRI/2020/08/027099 (Registered with Clinical Trials Registry- India).

Keywords: Autism Spectrum Disorder; Early Intensive Behavioural Intervention; Early Intervention; Family Mediated Intervention; Indian scale for assessment of autism; Randomised Controlled Trial.