Theory of Mind-based Social Competence Group Intervention

Official title

Theory of Mind-based Social Competence Group Intervention (ToM-SCGI) in Children With Autism Spectrum Disorder: a Randomized Controlled Trial

Overview

This clinical study introduces a novel intervention, the Theory of Mind-Based Social Competence Group Intervention (ToM-SCGI), designed to improve theory of mind and social competence in children with autism spectrum disorder (ASD). Investigators hypothesize that the ToM-SCGI, which focuses on enhancing the ability to understand others' thoughts and feelings-known as "theory of mind"-will positively impact children's theory of mind abilities, application of these abilities, and overall social competence. In a carefully structured randomized controlled trial (RCT), investigators aim to validate the effectiveness of the ToM-SCGI. Additionally, investigators will examine if a child's verbal IQ and social interaction style can influence the effectiveness of the ToM-SCGI. Through three comprehensive phases-developing and piloting the intervention, conducting the RCT, and examining the mediation and moderation effects-investigators expect that the ToM-SCGI will provide lasting benefits in the social development of children with ASD.

Detailed description

This study is a single-blind RCT aiming to enroll 120 pairs of participants, comprising 120 children with ASD and caregivers. The participants will be equally divided into two experimental groups and a control group, with 40 pairs each. The experimental groups will participate in the Theory of Mind-Based Social Competence Group Intervention (ToM-SCGI) focusing on theory of mind and social competence, while the control group will engage in regular occupational therapy without a specific focus on theory of mind or social competence. One experimental group will receive the intervention once a week for 12 weeks, while the other will receive it twice a week for 6 weeks.

The study consists of four assessments: T0 screening, T1 pre-intervention, T2 post-intervention, and T3 follow-up three months later. The T0 assessment is conducted to screen and confirm eligibility. Randomization and allocation concealment are managed independently by a researcher not involved in the study, using Random Allocation Software 2.0. Randomly generated numbers and group assignments are placed in consecutively numbered, opaque, sealed envelopes. Once a child and caregiver provide consent and eligibility is confirmed, the envelopes are opened sequentially to assign participants to one of the experimental and control groups.

The T1 assessment establishes baseline data for efficacy evaluations before the interventions. All groups then undergo the respective interventions. The T2 assessment, conducted within one week after completing the interventions, serves as the post-intervention measure. The final T3 follow-up assessment takes place three months after the intervention ends, to evaluate long-term effects.

Interventions

• Behavioral Theory of mind-based social competence group intervention
  The ToM-SCGI is designed as a group intervention, with 60-minute sessions held weekly, either once or twice, and led by trained therapists. Two caregiver meetings are conducted in the middle and end of the interventions. The intervention process for each session is as follows: 1. Warm-up Activities(5-10 minutes): review the previous group session and prepare for the current group activities. 2. Theory of Mind Instruction(10-15 minutes): based on the developmental stage of the children's theory

Primary outcome measures

• Observational Social Competence Assessment, OSCA [Time frame: Up to 1 week before the intervention, up to 1 week after completing the intervention, and 3 months after completing the intervention.]
• Theory of Mind Assessment, ToMA [Time frame: Up to 1 week before the intervention, up to 1 week after completing the intervention, and 3 months after completing the intervention.]
• Theory of Mind Task Battery, ToMTB [Time frame: Up to 1 week before the intervention, up to 1 week after completing the intervention, and 3 months after completing the intervention.]
• Theory of Mind Inventory-Second Edition, ToMI-2 [Time frame: Up to 1 week before the intervention, up to 1 week after completing the intervention, and 3 months after completing the intervention.]
• Vineland Adaptive Behavior Scales, Third Edition, VABS-3 [Time frame: Up to 1 week before the intervention, up to 1 week after completing the intervention, and 3 months after completing the intervention.]

Eligibility criteria

Inclusion criteria

• chronological age between 3 and 10 years;
• diagnosed with Autism Spectrum Disorder (ASD), Autism, Asperger's Syndrome, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) according to DSM-5 or the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) criteria by a trained psychiatrist or pediatrician;
• absence of additional neurological or psychiatric conditions;
• a T-score of 60 or higher on the Social Responsiveness Scale-Second Edition (SRS-2) and a score of 30 or higher on the Childhood Autism Rating Scale™, Second Edition (CARS™2);
• a Verbedal Comprehension Index (VCI) score of 70 or higher on the Wechsler Preschool and Primary Scale of Intelligence IV (WPPSI-IV) or the Wechsler Intelligence Scale for Children IV (WISC-IV).

Exclusion criteria

• inability to follow instructions or complete the entire assessment process;
• symptoms related to organic brain dysfunction (e.g., epilepsy);
• uncorrectable auditory or visual impairments.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06509152 · B-BR-112-082

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗