Clinical trial NCT05846308: The Effectiveness of Group Interpersonal Synchrony in Young Autistic Adults' Work Environment
Official title: The Effectiveness of Group Interpersonal Synchrony in Young Autistic Adults' Work Environment: A Mixed Methods RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Interpersonal Synchrony
Prosociality
work-related stress
Social closeness
Sense of belonging
Need to belong
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each participant will be randomized into one of two groups.
Primary purpose: TREATMENT

Brief summary: Background: Few autistic adults are able to integrate successfully into the world of work given their difficulties adapting to the social and stressful aspects of work environments. Interpersonal synchrony, when two or more individuals share body movements or sensations, is a powerful force that consolidates human groups while promoting the ability to self-regulate and cooperate with others. The abilities to self-regulate and cooperate are crucial for maintaining a calm and productive work environment.

Objectives: This randomized controlled trial (RCT) aims to assess the effects of group interpersonal synchrony on prosociality and work-related stress of young autistic adults in their work environment.

Methods: This mixed-methods RCT will investigate two movement-based group synchronous and non-synchronous intervention conditions. The sample will be composed of young adults enrolled in an innovative Israeli program designed to integrate cognitively-abled 18- to 25-year-old autistic adults into the Israeli army work force. The movement-based intervention sessions will take place in groups of 10-14 participants, once a week for 10 weeks. Questionnaires, behavioral collaborative tasks and semi-structured interviews will be conducted. Quantitative data will be collected for each participant at three points of time: before and after the intervention period, and four months after the end of the intervention. Qualitative data will be collected after the intervention period in interviews with 15% of the participants.

Detailed description: Background: Few autistic adults are able to integrate successfully into the world of work given their difficulties adapting to the social and stressful aspects of work environments. Interpersonal synchrony, when two or more individuals share body movements or sensations, is a powerful force that consolidates human groups while promoting the ability to self-regulate and cooperate with others. The abilities to self-regulate and cooperate are crucial for maintaining a calm and productive work environment.

Objectives: The objectives are to determine:

1. whether a synchronized group intervention will have an immediate and/or long-term positive effect on participants' prosociality and work-related stress.
2. whether this effect will be mediated by participants' reported social closeness and sense of belonging.
3. whether this effect will be influenced by participants' need to belong as reported before the intervention.
4. how participants perceive the intervention as affecting their prosociality and work-related stress.
5. in what ways the participants' perception of the intervention as affecting their prosociality and work-related stress will contribute to a better understanding of the intervention effect.

Methods: A mixed methods approach will be applied, where quantitative and qualitative data are collected and analyzed in parallel.

Participants: The sample will be composed of young adults (n=60) enrolled in an innovative Israeli program designed to integrate cognitively-abled 18- to 25-year-old autistic adults into the Israeli army workforce.

Sample Size: An a-priori power analysis indicated that a total sample size of 42 participants would be needed to detect medium effects defined as f=0.2, with 80% power and alpha at .05, using a repeated measure, within-between interaction ANOVA. This sample size might not be sufficient for detecting the mediated effect needed to respond to the second study objective with 80% power and alpha of .05. Therefore, we will recruit at least N = 60 participants (30 in each intervention group) to plan for possible dropouts.

Study Design and Procedures: This is a two-arm, randomized controlled trial (RCT) in which participants will be randomly assigned to one of two groups: synchronous and non-synchronous movement-based interventions. The movement-based intervention sessions will take place in groups of 10-14 participants, once a week for 10 weeks. A structured physical training protocol will be used for each condition. Each protocol is composed of 10 physical training sessions, each lasting 60 minutes. The protocols differ in terms of using synchronous activity vs. non-synchronous activity. They do not differ in terms of physical exercise type or duration to control for the effect of exercise type and duration on the dependent variables. Questionnaires, behavioral collaborative tasks and semi-structured interviews will be conducted. Quantitative data will be collected for each participant at three points of time: before and after the intervention period, and four months after the end of the intervention. Qualitative data will be collected after the intervention period in interviews with 15% of the participants.

Eligibility criteria: Inclusion Criteria:

* Trainees must have an official diagnosis of an autism spectrum disorder as assessed by a child psychiatrist or clinical psychologist according to the DSM-V.

Exclusion Criteria:

* Trainees with severe sensory impairments such as blindness or deafness and/or severe physical disability.

Primary outcomes:
measure: Work-related stress during baseline
timeFrame: Up to 1 month before start of intervention
measure: Work-related stress during post-intervention
timeFrame: Up to 1 month after end of intervention
measure: Work-related stress during follow-up
timeFrame: Between 3-4 month after end of intervention
measure: Cognitive cooperation during baseline
timeFrame: Up to 1 month before start of intervention
measure: Cognitive cooperation during post-intervention
timeFrame: Up to 1 month after end of intervention
measure: Cognitive cooperation during follow-up
timeFrame: Between 3-4 month after end of intervention
measure: Behavioral cooperation during baseline
timeFrame: Up to 1 month before start of intervention
measure: Behavioral cooperation during post-intervention
timeFrame: Up to 1 month after end of intervention
measure: Behavioral cooperation during follow-up
timeFrame: Between 3-4 month after end of intervention
Secondary outcomes:
measure: Social Closeness during baseline
timeFrame: Up to 1 month before start of intervention
measure: Social Closeness during post-intervention
timeFrame: Up to 1 month after end of intervention
measure: Social Closeness during follow-up
timeFrame: Between 3-4 month after end of intervention
measure: Friendship Closeness during baseline
timeFrame: Up to 1 month before start of intervention
measure: Friendship Closeness during post-intervention
timeFrame: Up to 1 month after end of intervention
measure: Friendship Closeness during follow-up
timeFrame: Between 3-4 month after end of intervention
measure: Sense of Belonging during baseline
timeFrame: Up to 1 month before start of intervention
measure: Sense of Belonging during post-intervention
timeFrame: Up to 1 month after end of intervention
measure: Sense of Belonging during follow-up
timeFrame: Between 3-4 month after end of intervention
measure: Need to Belong during baseline
timeFrame: Up to 1 month before start of intervention
measure: Need to Belong during post-intervention
timeFrame: Up to 1 month after end of intervention
measure: Need to Belong during follow-up
timeFrame: Between 3-4 month after end of intervention
Other outcomes:
Locations:
city: Or Yehuda
country: Israel
facility: Roim Rachok Program
Study officials:
affiliation: University of Haifa, Israel
name: Tal-Chen Rabinowitch, PhD
role: PRINCIPAL_INVESTIGATOR
References: