Theory of Mind-based Social Competence Group Intervention (ToM-SCGI)

National Cheng-Kung University

Status: Begins enrollment this month

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Theory of mind-based social competence group intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06509152

B-BR-112-082

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

ToM-SCGI-12

Experimental group

Description:

The ToM-SCGI-12 is designed as a 12-week group intervention, with 60-minute sessions held weekly and led by trained therapists. Each group consists of 3 to 6 children with ASD, assigned based on assessments of children's age, verbal IQ, theory of mind abilities, and social skills. Caregivers can observe the children's performance in the group and document the group's themes and contents using observation and feedback forms. Caregiver meetings are conducted in the 6th and 12th weeks of the intervention to discuss the children's progress, enhance caregivers' interaction skills, and motivate continued practice at home. After the intervention concludes, caregivers' feedback is also collected through questionnaires to emphasize the role of family in the intervention.

Treatment:

Behavioral: Theory of mind-based social competence group intervention

ToM-SCGI-6

Active Comparator group

Description:

The ToM-SCGI-6 is designed as a 6-week group intervention, with two 60-minute sessions held weekly and led by trained therapists. Each group consists of 3 to 6 children with ASD, assigned based on assessments of children's age, verbal IQ, theory of mind abilities, and social skills. Caregivers can observe the children's performance in the group and document the group's themes and contents using observation and feedback forms. Caregiver meetings are conducted in the 6th and 12th weeks of the intervention to discuss the children's progress, enhance caregivers' interaction skills, and motivate continued practice at home. After the intervention concludes, caregivers' feedback is also collected through questionnaires to emphasize the role of family in the intervention.

Treatment:

Behavioral: Theory of mind-based social competence group intervention

Control group

No Intervention group

Description:

The control group participated in conventional occupational therapy that did not focus on theory of mind or social competence. The duration and length of the intervention were the same as those of the experimental group.