Clinical trial NCT06509152: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: theory of mind
social competence
randomized, controlled trial
group intervention
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. chronological age between 3 and 10 years;
2. 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;
3. absence of additional neurological or psychiatric conditions;
4. 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);
5. 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:

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

Primary outcomes:
measure: Observational Social Competence Assessment, OSCA
timeFrame: Up to 1 week before the intervention, up to 1 week after completing the intervention, and 3 months after completing the intervention.
measure: Theory of Mind Assessment, ToMA
timeFrame: Up to 1 week before the intervention, up to 1 week after completing the intervention, and 3 months after completing the intervention.
measure: Theory of Mind Task Battery, ToMTB
timeFrame: Up to 1 week before the intervention, up to 1 week after completing the intervention, and 3 months after completing the intervention.
measure: Theory of Mind Inventory-Second Edition, ToMI-2
timeFrame: Up to 1 week before the intervention, up to 1 week after completing the intervention, and 3 months after completing the intervention.
measure: Vineland Adaptive Behavior Scales, Third Edition, VABS-3
timeFrame: Up to 1 week before the intervention, up to 1 week after completing the intervention, and 3 months after completing the intervention.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nattional Cheng Kung University
name: Kuan-Lin Chen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: