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Autism Spectrum DisorderNCT05846308

The Effectiveness of Group Interpersonal Synchrony in Young Autistic Adults' Work Environment

A study testing Structured synchronous physical training and Structured non-synchronous physical training in people with Autism Spectrum Disorder, run by University of Haifa at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 25 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Structured synchronous physical training and Structured non-synchronous physical training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteIsrael
Study dates
1 Aug 2021to 1 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Roim Rachok Program

    Or Yehuda

Other trials in Israel

About this study

Official title: The Effectiveness of Group Interpersonal Synchrony in Young Autistic Adults' Work Environment: A Mixed Methods RCT

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.

Read the 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.

Being tested
Structured synchronous physical training, Structured non-synchronous physical training
Keywords
Interpersonal Synchrony, Prosociality, work-related stress, Social closeness, Sense of belonging, Need to belong
Medical subject headings
Autism Spectrum Disorder, Occupational Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured synchronous physical trainingBehavioural

    The instructors and the participants will form a circle facing each other while doing the physical exercises. To facilitate interpersonal synchrony, the participants will be instructed to do the same physical exercises (spatial synchrony) together at the same pace (rhythmic synchrony). Each session will consist of four parts:

    1. Warm-up (10 minutes)
    2. Social Game (10 minutes)
    3. Main training (30 minutes): Each session will contain two sets, each consisting of seven fixed exercises with a resting period of 10-15 seconds between each. Each exercise will be performed at one of three different paces: Slow - one movement cycle per 2 seconds, Medium - one movement cycle per 1 second and Fast - two movement cycles per 1 second.
    4. Cool-down (10 minutes)
  • Structured non-synchronous physical trainingBehavioural

    The participants will do the same physical exercises as the participants in the synchronous group but in the form of circuit training with seven stations. The circuit training will require the participants to do a different physical exercise at a different pace at each station. A detailed description of the exercises will be provided for each station. The instructors will demonstrate all the exercises before the beginning of training. The participants will be instructed to do the exercise for a set period of time, the same duration used in the synchronous group. The circuit training stations will be in the form of a circle but will be set up so that the participants do not to face each other when doing the exercises to prevent spontaneous synchronization. Each session will consist of four parts, the same as in the synchronous intervention.

Study groups in NCT05846308
Study groupRoleWhat they receive
Synchronous conditionActive comparatorThis arm (n=30) will include a synchronous intervention only.
Receives: Behavioral: Structured synchronous physical training
Non-synchronous conditionActive comparatorThis arm (n=30) will include a non-synchronous intervention only.
Receives: Behavioral: Structured non-synchronous physical training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Work-related stress during baseline

    Work-related stress will be measured using the Hebrew adaptation of the Irritation Scale. This scale comprises eight items, three of which assess cognitive irritation and five of which assess emotional irritation. Items are rated on a 7-point Likert scale ranging from "Strongly Disagree" (1) to "Strongly Agree" (7).

    Measured: Up to 1 month before start of intervention

  2. Work-related stress during post-intervention

    Work-related stress will be measured using the Hebrew adaptation of the Irritation Scale. This scale comprises eight items, three of which assess cognitive irritation and five of which assess emotional irritation. Items are rated on a 7-point Likert scale ranging from "Strongly Disagree" (1) to "Strongly Agree" (7).

    Measured: Up to 1 month after end of intervention

  3. Work-related stress during follow-up

    Work-related stress will be measured using the Hebrew adaptation of the Irritation Scale. This scale comprises eight items, three of which assess cognitive irritation and five of which assess emotional irritation. Items are rated on a 7-point Likert scale ranging from "Strongly Disagree" (1) to "Strongly Agree" (7).

    Measured: Between 3-4 month after end of intervention

  4. Cognitive cooperation during baseline

    Cognitive cooperation will be measured using the Public Good Game task: Participants will be told they will be given 30 NIS and that they can donate some or all of it to a group investment. The money in the group investment will then be doubled and divided equally among all members of the group. Cooperation on this task will be operationalized by the amount of money each participant decides to donate to the group investment.

    Measured: Up to 1 month before start of intervention

  5. Cognitive cooperation during post-intervention

    Cognitive cooperation will be measured using the Public Good Game task: Participants will be told they will be given 30 NIS and that they can donate some or all of it to a group investment. The money in the group investment will then be doubled and divided equally among all members of the group. Cooperation on this task will be operationalized by the amount of money each participant decides to donate to the group investment.

    Measured: Up to 1 month after end of intervention

  6. Cognitive cooperation during follow-up

    Cognitive cooperation will be measured using the Public Good Game task: Participants will be told they will be given 30 NIS and that they can donate some or all of it to a group investment. The money in the group investment will then be doubled and divided equally among all members of the group. Cooperation on this task will be operationalized by the amount of money each participant decides to donate to the group investment.

    Measured: Between 3-4 month after end of intervention

  7. Behavioral cooperation during baseline

    Behavioral cooperation will be measured using the Collection task: Participants will have to work together to pick up 100 small washers (a flat plastic coin with a diameter of 4 cm). Cooperation on this task will be operationalized by participants' effort represented by their step rate (SR). SR will be measured using a wearable fitness tracker (Fitbit Inspire 2) that will be attached to the participants' wrists using a special band.

    Measured: Up to 1 month before start of intervention

  8. Behavioral cooperation during post-intervention

    Behavioral cooperation will be measured using the Collection task: Participants will have to work together to pick up 100 small washers (a flat plastic coin with a diameter of 4 cm). Cooperation on this task will be operationalized by participants' effort represented by their step rate (SR). SR will be measured using a wearable fitness tracker (Fitbit Inspire 2) that will be attached to the participants' wrists using a special band.

    Measured: Up to 1 month after end of intervention

  9. Behavioral cooperation during follow-up

    Behavioral cooperation will be measured using the Collection task: Participants will have to work together to pick up 100 small washers (a flat plastic coin with a diameter of 4 cm). Cooperation on this task will be operationalized by participants' effort represented by their step rate (SR). SR will be measured using a wearable fitness tracker (Fitbit Inspire 2) that will be attached to the participants' wrists using a special band.

    Measured: Between 3-4 month after end of intervention

Secondary outcomes (12)
  1. Social Closeness during baseline

    Social Closeness will be measured using the Inclusion of Other in Self Scale. This scale is made up of seven Venn diagram-like pictures where one circle represents the participant and the other circle represents the entire intervention group.

    Measured: Up to 1 month before start of intervention

  2. Social Closeness during post-intervention

    Social Closeness will be measured using the Inclusion of Other in Self Scale. This scale is made up of seven Venn diagram-like pictures where one circle represents the participant and the other circle represents the entire intervention group.

    Measured: Up to 1 month after end of intervention

  3. Social Closeness during follow-up

    Social Closeness will be measured using the Inclusion of Other in Self Scale. This scale is made up of seven Venn diagram-like pictures where one circle represents the participant and the other circle represents the entire intervention group.

    Measured: Between 3-4 month after end of intervention

  4. Friendship Closeness during baseline

    Friendship Closeness will be measured using the Hebrew adaptation of the Friendship Closeness Inventory (FCI). The FCI is composed of 49 items that measure closeness in same-sex friendships and is divided into three distinguishable yet related subscales: Emotional Closeness (EC), Behavioral Closeness (BC), and Cognitive Closeness (CC). Items are rated on a 7-point Likert scale ranging from "Strongly Disagree" (1) to "Strongly Agree" (7). For the purposes of this study, the first item will be adjusted to include a reference to participants in the intervention group alone.

    Measured: Up to 1 month before start of intervention

  5. Friendship Closeness during post-intervention

    Friendship Closeness will be measured using the Hebrew adaptation of the Friendship Closeness Inventory (FCI). The FCI is composed of 49 items that measure closeness in same-sex friendships and is divided into three distinguishable yet related subscales: Emotional Closeness (EC), Behavioral Closeness (BC), and Cognitive Closeness (CC). Items are rated on a 7-point Likert scale ranging from "Strongly Disagree" (1) to "Strongly Agree" (7). For the purposes of this study, the first item will be adjusted to include a reference to participants in the intervention group alone.

    Measured: Up to 1 month after end of intervention

  6. Friendship Closeness during follow-up

    Friendship Closeness will be measured using the Hebrew adaptation of the Friendship Closeness Inventory (FCI). The FCI is composed of 49 items that measure closeness in same-sex friendships and is divided into three distinguishable yet related subscales: Emotional Closeness (EC), Behavioral Closeness (BC), and Cognitive Closeness (CC). Items are rated on a 7-point Likert scale ranging from "Strongly Disagree" (1) to "Strongly Agree" (7). For the purposes of this study, the first item will be adjusted to include a reference to participants in the intervention group alone.

    Measured: Between 3-4 month after end of intervention

  7. Sense of Belonging during baseline

    Sense of belonging will be measured using the Hebrew adaptation of the General Sense of Belonging Scale. This scale is composed of 12 items that measure sense of belonging (achieved belongingness). Items are rated on a 7-point Likert scale ranging from "Strongly Disagree" (1) to "Strongly Agree" (7). For the purposes of this study, the scale will be adjusted so that the words "other people" or "others" will be replaced by the words "participants in the physical training group".

    Measured: Up to 1 month before start of intervention

  8. Sense of Belonging during post-intervention

    Sense of belonging will be measured using the Hebrew adaptation of the General Sense of Belonging Scale. This scale is composed of 12 items that measure sense of belonging (achieved belongingness). Items are rated on a 7-point Likert scale ranging from "Strongly Disagree" (1) to "Strongly Agree" (7). For the purposes of this study, the scale will be adjusted so that the words "other people" or "others" will be replaced by the words "participants in the physical training group".

    Measured: Up to 1 month after end of intervention

  9. Sense of Belonging during follow-up

    Sense of belonging will be measured using the Hebrew adaptation of the General Sense of Belonging Scale. This scale is composed of 12 items that measure sense of belonging (achieved belongingness). Items are rated on a 7-point Likert scale ranging from "Strongly Disagree" (1) to "Strongly Agree" (7). For the purposes of this study, the scale will be adjusted so that the words "other people" or "others" will be replaced by the words "participants in the physical training group".

    Measured: Between 3-4 month after end of intervention

  10. Need to Belong during baseline

    Need to Belong will be measured using the Hebrew adaptation of the Need to Belong Scale. This scale is composed of ten items rated on a 5-point Likert scale ranging from "Strongly Disagree" (1) to "Strongly Agree" (5).

    Measured: Up to 1 month before start of intervention

  11. Need to Belong during post-intervention

    Need to Belong will be measured using the Hebrew adaptation of the Need to Belong Scale. This scale is composed of ten items rated on a 5-point Likert scale ranging from "Strongly Disagree" (1) to "Strongly Agree" (5).

    Measured: Up to 1 month after end of intervention

  12. Need to Belong during follow-up

    Need to Belong will be measured using the Hebrew adaptation of the Need to Belong Scale. This scale is composed of ten items rated on a 5-point Likert scale ranging from "Strongly Disagree" (1) to "Strongly Agree" (5).

    Measured: Between 3-4 month after end of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start1 Aug 2021
  3. Primary completion1 Jun 2023
  4. Study completion1 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Each participant will be randomized into one of two groups.
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05846308
Sponsor's protocol ID
2595
Status last verified
Mar 2024
First submitted
14 Apr 2023
Last updated
27 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dvir T, Elefant C, Rabinowitch TC. Group Interpersonal Synchrony Increases Prosocial Behavior in Young Autistic Adults: A Randomized Controlled Trial. J Autism Dev Disord. 2025 Jul 5. doi: 10.1007/s10803-025-06949-y. Online ahead of print.

    PubMed 40615734
  • Dvir T, Rabinowitch TC, Elefant C. The effectiveness of group interpersonal synchrony in young autistic adults' work environment: A mixed methods RCT study protocol. PLoS One. 2024 Jul 31;19(7):e0307956. doi: 10.1371/journal.pone.0307956. eCollection 2024.

    PubMed 39083478

Questions about this trial

What is this clinical trial studying?

A study testing Structured synchronous physical training and Structured non-synchronous physical training in people with Autism Spectrum Disorder, run by University of Haifa at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Work-related stress during baseline (time frame: Up to 1 month before start of intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05846308, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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