Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509152
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-17
Brief Title:
Theory of Mind-based Social Competence Group Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Theory of Mind-based Social Competence Group Intervention ToM-SCGI in Children With Autism Spectrum Disorder a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ToM-SCGI
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 childrens 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 childs 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
In a carefully structured randomized controlled trial RCT investigators aim to validate the effectiveness of the ToM-SCGI Additionally investigators will examine if a childs 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 20 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
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 20 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None