AgingPlayNCT06081725
Playfulness in Online and Face-to-face Interactions, From Adulthood to Aging
A study testing Playful interactions in an online format and Playful interactions in a face to face format in people with Aging and Cognitive Function 1, Social, run by University of Haifa at 4 sites in Israel.
Trial summary
Playful interactions have an important role in human sociality. During playful interactions, two individuals continuously co-create an imaginary world together, such as playing roles in an imaginary scene or co-creating synchronized movements together. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Function 1, Social, Social Behavior
- What is being tested?
- Playful interactions in an online format and Playful interactions in a face to face format
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 4 sitesIsrael
- Study dates
- 20 Jan 2023to 5 Oct 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy cognitive functioning for this age-range with a Mini-Mental State Examination above 24, as reported by the community centers or adult day centers
- No history of auditory or visual pathology, as indicated in a self-report
- No known clinical diagnosis of a major psychiatric disorder or drug/alcohol abuse, as reported by social worker at the community center and self report
- Speaking Hebrew
- Participants who will complete the three study sessions
- Age above 60 years old.
Who cannot join
- Mini-Mental State Examination beyond 25, as reported by the community centers or adult day centers
- Participants whose responses indicate that they did not follow or did not understand instructions
- Participants with auditory or visual pathology, as indicated in a self-report
- Participants who do not speak Hebrew.
- Participants who will not complete the three study sessions
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Beit-horim
Haifa, 3498838
Beit Avraham - Sephardic community
Haifa
Uziel community center for the aging population
Ramat Gan
Kibutz Givat Brenner
Rehovot
About this study
Official title: Playfulness in Online and Face-to-face Interactions, From Adulthood to Aging: Physiological, Cognitive, and Emotional Mechanisms and Outcomes
Playful interactions have an important role in human sociality. During playful interactions, two individuals continuously co-create an imaginary world together, such as playing roles in an imaginary scene or co-creating synchronized movements together. Playful interactions are characterized by an enhanced sense of flow and joy and have been associated with physical and psychological well-being across the lifespan. This research team and others have shown that playful interactions are particularly beneficial for the older population, which are at higher risk of cognitive decline and social isolation. The overarching aim of this proposal is to conduct an in-depth investigation of the effects of playful interactions, in older population. Specifically the investigators will test the effect of short playful interaction on cognitive measures, as well as social and affective indices, and compare them to a non-playful interaction (such exercise class, or personal conversation).
Read the detailed description
Play is a crucial activity that supports human beings and animals throughout the life course, and enables individuals to acquire and practice complex physical, cognitive and social and contemplative skills. The term 'play' has many meanings; over the years, psychologists and biologists have tried to define criteria for the identification of playful behavior. Generally speaking, playful behavior is spontaneous and rewarding to the individual, as players play for the sake of playing; it has no immediate utility beside the play itself (as opposed to, for example, rule-governed competitive sports activities). The play occurs outside ordinary reality, yet maintains a relation with it. Playful behavior consists of actions or thoughts, expressed in novel combinations (such as when a parent takes the role of a child); it is grounded in positive social exchanges, in which the individual is more inclined to behave or think in a spontaneous and flexible way.
In the current study, the investigators will focus on a particular form of social playfulness, termed improvised dramatic interactions (IDI), which plays a central role in creative arts therapies and contemplative arts. IDI can occur on different levels, ranging from non-verbal expressions such as emotions, gestures, and postures, to verbal communication, which involve real-time dialogue and narrative progression. It is the act of spontaneous co-creation which requires people to cooperate on a moment-to-moment basis in order to keep playing. The participants continuously exchange, co-adapt, and co-create. Accordingly, IDI is believed to present an ongoing challenge (and provide training) for different aspects of executive functions and to powerfully trigger a multitude of attentional, perceptual, and social processes. Studies of IDI conducted among younger populations point to its tangible beneficial effects on certain aspects of mental health, such as a reduction of depressive and anxiety symptoms and an enhancement of mood and psychological well-being.
Given the potential of IDI to improve mental health, it is surprising that research on this topic is still sparse; frequently, it lacks well matched control activities and underlying mechanisms are not fully understood. In addition, most studies on improvised playful interactions have focused on children, adolescents and young adults. In this study the investigators aim to examine the beneficial effects of a short playful interaction on the cognitive, social, and mood of older people. the investigators will examine changes in indices of mood, mental health, social functioning, cognition compared to an active control intervention. The study also aims to compare between online playful interactions to face to face.
In addition, in the past two decades there has been a shift toward the development of "tailor-made" interventions that fit individual needs and abilities. This trend is especially important in aging, given increased variability in personality and cognitive and sensory characteristics. In the current study, the investigators aim to investigate the mediating role of personality traits and cognitive functions in connection to the beneficial effect of playful interactions in aging.
The investigators hypnotized that playful interactions will induce greater effects on emotional and social indices, as well as on executive functioning, compared to more familiar social interactions. The investigators hypothesize that these effects will be found in older populations. The effects of short-term playful interaction tasks as compared to the matched social control condition will be preserved in the online format. Individuals' characteristics and personality traits will influence the effects of the interaction on the dependent variables.
Participants
80 participants (up to 95, considering attrition).
To detect a significant interaction between conditions and participant groups (ANOVA within-between interactions with repeated measures as a proxy for MLM, with 4 groups, and 6 types of repeated measures), assuming a medium-small effect size (f2 = .20), and a conservative estimate of correlation (r = .33), a sample size of at least 18 in each arm group is required to achieve a power of 0.90, using GPower. The investigators will recruit 20 participants per group expecting attrition.
Procedure
- The study will take place in six sites including assisted living facilities, community centers and adults day centers in Israel.
- Participants will be invited by the research assistance to take part in the study.
- Participants who will be willing to take part in the study will meet with the research team and will read and signed an informed consent form before participating in the study.
- Following the informed consent signing, base line measures will be collected (traits and cognitive measures) (T0).
- Following base line assessment participants will be randomly assigned to four arms. At first, they will randomly assign to one of two conditions (online or face to face). The interactions will be separated in a week. A random half of the two conditions of participants (online and face t face) will be assigned to practice the playful interaction at the first week and control interaction in the second week, whereas for the other half this order will be reversed.
- One designated experiment assigned each participant randomly to one of the two interactions (playful or control), to keep the other experiments blind to the activity.
- For each participant, separate interactions will be conducted by a different experimenter.
- These are the four arms:
- Playful interactions operationalized by dramatic improvisation techniques based on verbal and non-verbal elements in face to face setting
- Playful interactions operationalized by dramatic improvisation techniques based on verbal and non-verbal elements in online setting
- An active control condition that involves introductory conversation and movement exercises in face to face setting in face to face setting
- An active control condition that involves introductory conversation and movement exercises in face to face setting in online setting
- The interventions will meet the following criteria: a) ease of implementation in an online system; b) a short interaction between 15-20 minutes. Both interactions incorporated bodily movement; however, the playful interaction encompassed elements of co-creation, spontaneity, and innovation, whereas the control interaction adhered to a more conventional and routine approach.
- The online interactions will take place using the ZOOM video conference software under laboratory conditions.
- All interactions will be guided by graduate students of the Theatre department at the university of Haifa or drama therapy students or theatre facilitator - the facilitators, who are unfamiliar to the participants. One designated experiment assigned each facilitator randomly to one of the two interactions (playful or control), to keep the other experiments blind to the activity. The facilitators will be randomly assigned to the different interactions, so that for each participants the separate interactions were conducted by a different facilitator.
- All interactions will be videoed recorded. A fidelity check will be done by the research team every week to make sure each participants was given the correct interaction (playful or control), and that each interaction included all phases in the protocol.
- Both interactions will commence with a battery of tests and self-reports before (T1) and after each session (T2). The battery of tests was conducted by an experimenter who will be blind to the type of intervention (playful or control).
- All self-reports and tests will be administered individually in a quiet and well-lighted room before and after each activity. Items will be read aloud to participants when this will be necessary, and responses will be given orally and coded by the researcher. At the end of the initial assessment (T1), participants transitioned to a designated room, equipped with a computer connected to Zoom, or in case of face to face interaction they will meet the facilitator. They will be introduced to the facilitator previously unknown to them and then the experimenter will leave (so they won't be able to know which intervention will be delivered). Each interaction (playful or control) will be administered by a different and unfamiliar experimenter.
- At the end of the interaction, participants reconvene with the primary researcher for the administration of the second assessment (T2). It is important to note that the investigators will take pains to ensure that the experimenter administering the initial and second assessment will be blind to the experimental condition.
Dependent variables
At base line (T0):
- Cognitive tests: forward and backward digit span (WISC III, 1991), phonetic fluency taken (Kave, 2005) from the Hebrew version of the WAIS-IV, ANT attention network test (for younger adults), flanker task (for older adults).
- Traits (openness to experience and extraversion), attachment styles, novelty seeking and social anxiety will be assessed as control variables and for exploratory analysis to investigate sub-populations for whom playful interactions are most beneficial.
Pre interaction (T1)
- Mood Post interaction (T2)
- Cognitive tests
- Mood
- Flow Questionnaire
- Subjective Arousal
- Closeness
- Perceived Partner Responsivness
- Freiburg Mindfulness Inventory
Data analysis
To test the effects of playful interactions in all of the above measures and experiments the investigators use various tools. As the investigators do not wish to assume equality of variance and a normal distribution, they will apply a mixed-level linear model (MLM). The various measures (cognitive, social, and emotional measures) will serve as the dependent variables; age group (young vs. older adults) and platform (online or F2F) as the between-participant variables, and time of testing (before vs. after) and experimental condition (playful interaction vs. control) as the repeated measures. Follow-up analyses will attempt to find connections between the different dependent measures and relate it to the different experimental groups, traits and age groups. This will be done in exploratory mediation and moderation analyses as well as by correlation analysis
- Being tested
- Playful interactions in an online format, An active control condition in a face-to-face format, An active control condition in an online format, Playful interactions in a face to face format
- Medical subject headings
- Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Playful interactions in an online formatBehavioural
The activity is grounded in dramatic improvisation and comprises several games: a ball game, an association game, a mirror game, a movement story game. The intervention will be conducted by zoom
An active control condition in a face-to-face formatBehavioural
The activity consisted of three parts: A structured conversation centered around hobbies. In the second part an exercise in words - singular plural. In the third part, participants will be engaged in a movement practice resembling an exercise class.
An active control condition in an online formatBehavioural
The activity consisted of three parts: A structured conversation centered around hobbies. In the second part an exercise in words - singular plural. In the third part, participants will be engaged in a movement practice resembling an exercise class. The intervention will be conducted conducted by zoom
Playful interactions in a face to face formatBehavioural
The activity is grounded in dramatic improvisation and comprises several games: a ball game, an association game, a mirror game, a movement story game.
| Study group | Role | What they receive |
|---|---|---|
| Playful interactions first session in a face-to-face format | Experimental | Playful interactions operationalized by dramatic improvisation techniques based on verbal and non-verbal elements in a face-to-face format. This arm will take part in the playful interactions in a face-to-face format in the first session and in the active control in the second session Receives: Behavioral: An active control condition in a face-to-face format; Behavioral: Playful interactions in a face to face format |
| An active control condition first session in a face-to-face format | Active comparator | An active control condition that involves introductory conversation and movement exercises in a face-to-face format. This arm will take part in the active control in a face-to-face format in the first session and in the playful interaction in the second session Receives: Behavioral: An active control condition in a face-to-face format; Behavioral: Playful interactions in a face to face format |
| Playful interactions first session in an online format. | Experimental | Playful interactions are operationalized by dramatic improvisation techniques based on verbal and non-verbal elements in an online format. This arm will take part in the playful interactions in an online format in the first session and the online active control in the second session Receives: Behavioral: Playful interactions in an online format; Behavioral: An active control condition in an online format |
| An active control condition first session in an online format | Active comparator | An active control condition that involves introductory conversation and movement exercises in an online format. This arm will take part in the active control in an online format in the first session and in the online playful interaction in the second session. Receives: Behavioral: Playful interactions in an online format; Behavioral: An active control condition in an online format |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digit span
Digit Span test. consists of two stages (WISC III, 1991): a) Forward Digit Span to evaluate short-term memory. b) Backward Digit Span to assess working memory.
Measured: (1) Base line (2) one week following baseline and immediately after the first interaction (3) two weeks following baseline and immediately after the second interaction
Phonetic fluency
Phonetic fluency taken (Kave, 2005) from the Hebrew version of the WAIS-IV,
Measured: (1) Base line (2) one week following baseline and immediately after the first interaction (3) two weeks following baseline and immediately after the second interaction
Flanker task
(Fan et al., 2005, 2009) attention - response time for correct answers
Measured: (1) Base line (2) one week following baseline and immediately after the first interaction (3) two weeks following baseline and immediately after the second interaction
Perceived Partner Responsiveness
Perceived Partner Responsiveness (Reis et al. 2017). A 4-item questionnaire will asses how one partner perceived the other. It will enable us to assess a relationship's development after these short interactions between unfamiliar partners.
Measured: (1) Base line (2) one week following baseline and immediately after the first interaction (3) two weeks following baseline and immediately after the second interaction
Closeness
was measured using a 3-item questionnaire found in Golland et al., 2019). Participants rated the degree to which they felt closeness, similarity and rapport towards the experimenter during the interaction toward the experimenter on a seven-point Likert scale from 1 (strongly disagree) to 5 (strongly agree): "During the experiment, I felt that I became closer to the other participant?".
Measured: (1) one week following baseline and immediately after the first interaction (2) two weeks following baseline and immediately after the second interaction
Mood
Mood will be assessed on the Positive and Negative Affect Schedule (Watson et al., 2008), a self-report inventory divided into two subscales assessing positive and negative affect. The inventory consists of 10 items for each subscale, scored on a scale ranging from 1 (very slightly or not at all) to 5 (extremely).
Measured: (1) Base line (2) one week following baseline, before and immediately after the first interaction (3) two weeks following baseline, before and immediately after the second interaction
Secondary outcomes (3)
Flow
Flow Questionnaire; a 9-item questionnaire (Csikszentmihalyi, 2000) that measures people's perceived state of flow in a specific context. The scale items reflect the nine flow factors. Participants will be asked to rate items such as "I felt like time passed quickly," "I really enjoyed what I was doing" on a seven-point scale, from 1 (strongly disagree) to 7 (strongly agree). For three dimensions of Flow the full subscale was measured: concentration, transformation of time, autotelic characteristic of the experience and control
Measured: (1) one week following baseline and immediately after the first interaction (2) two weeks following baseline and immediately after the second interaction
Mindfulness
Freiburg Mindfulness Inventory (FMI): A useful, valid and reliable questionnaire for measuring experience of mindfulness during the session with subjects without previous experience with contemplative practice [76]. We adapted the questionnaire to the current study. The adapted inventory consists of 8 items such as: "during the session I was open to the experience of the present moment", on a 5-point scale.
Measured: (1) one week following baseline and immediately after the first interaction (2) two weeks following baseline and immediately after the second interaction
Subjective Arousal
Subjective Arousal with one item will be measured using a 9-point scale
Measured: (1) Base line (2) one week following baseline, before and immediately after the first interaction (3) two weeks following baseline, before and immediately after the second interaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start20 Jan 2023
- Primary completion5 Oct 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly assigned to four arms. At first they will randomly assign to one of two conditions (online or face to face). On the second and third session the participants will be randomly assigned to a playful or control interaction. The interactions will be separated in a week. A random half of the participants will be assigned to practice the playful interaction at the first week and control interaction in the second week, whereas for the other half this order will be reversed.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shoshi Keisari, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081725
- Sponsor's protocol ID
- 181/22
- Acronym
- Play
- Status last verified
- Feb 2024
- First submitted
- 29 Sep 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On upon request
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Playfulness in Online and Face-to-face Interactions, From Adulthood to Aging: Physiological, Cognitive, and Emotional Mechanisms and Outcomes
- ClinicalTrials.gov ID
- NCT06081725
- Acronym / sponsor ID
- Play / 181/22
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Playful interactions have an important role in human sociality. During playful interactions, two individuals continuously co-create an imaginary world together, such as playing roles in an imaginary scene or co-creating synchronized movements together. Playful interactions are characterized by an enhanced sense of flow and joy and have been associated with physical and psychological well-being across the lifespan. This research team and others have shown that playful interactions are particularly beneficial for the older population, which are at higher risk of cognitive decline and social isolation. The overarching aim of this proposal is to conduct an in-depth investigation of the effects of playful interactions, in older population. Specifically the investigators will test the effect of short playful interaction on cognitive measures, as well as social and affective indices, and compare them to a non-playful interaction (such exercise class, or personal conversation).
Detailed description
Play is a crucial activity that supports human beings and animals throughout the life course, and enables individuals to acquire and practice complex physical, cognitive and social and contemplative skills. The term 'play' has many meanings; over the years, psychologists and biologists have tried to define criteria for the identification of playful behavior. Generally speaking, playful behavior is spontaneous and rewarding to the individual, as players play for the sake of playing; it has no immediate utility beside the play itself (as opposed to, for example, rule-governed competitive sports activities). The play occurs outside ordinary reality, yet maintains a relation with it. Playful behavior consists of actions or thoughts, expressed in novel combinations (such as when a parent takes the role of a child); it is grounded in positive social exchanges, in which the individual is more inclined to behave or think in a spontaneous and flexible way.
In the current study, the investigators will focus on a particular form of social playfulness, termed improvised dramatic interactions (IDI), which plays a central role in creative arts therapies and contemplative arts. IDI can occur on different levels, ranging from non-verbal expressions such as emotions, gestures, and postures, to verbal communication, which involve real-time dialogue and narrative progression. It is the act of spontaneous co-creation which requires people to cooperate on a moment-to-moment basis in order to keep playing. The participants continuously exchange, co-adapt, and co-create. Accordingly, IDI is believed to present an ongoing challenge (and provide training) for different aspects of executive functions and to powerfully trigger a multitude of attentional, perceptual, and social processes. Studies of IDI conducted among younger populations point to its tangible beneficial effects on certain aspects of mental health, such as a reduction of depressive and anxiety symptoms and an enhancement of mood and psychological well-being.
Given the potential of IDI to improve mental health, it is surprising that research on this topic is still sparse; frequently, it lacks well matched control activities and underlying mechanisms are not fully understood. In addition, most studies on improvised playful interactions have focused on children, adolescents and young adults. In this study the investigators aim to examine the beneficial effects of a short playful interaction on the cognitive, social, and mood of older people. the investigators will examine changes in indices of mood, mental health, social functioning, cognition compared to an active control intervention. The study also aims to compare between online playful interactions to face to face.
In addition, in the past two decades there has been a shift toward the development of "tailor-made" interventions that fit individual needs and abilities. This trend is especially important in aging, given increased variability in personality and cognitive and sensory characteristics. In the current study, the investigators aim to investigate the mediating role of personality traits and cognitive functions in connection to the beneficial effect of playful interactions in aging.
The investigators hypnotized that playful interactions will induce greater effects on emotional and social indices, as well as on executive functioning, compared to more familiar social interactions. The investigators hypothesize that these effects will be found in older populations. The effects of short-term playful interaction tasks as compared to the matched social control condition will be preserved in the online format. Individuals' characteristics and personality traits will influence the effects of the interaction on the dependent variables.
Participants
80 participants (up to 95, considering attrition).
To detect a significant interaction between conditions and participant groups (ANOVA within-between interactions with repeated measures as a proxy for MLM, with 4 groups, and 6 types of repeated measures), assuming a medium-small effect size (f2 = .20), and a conservative estimate of correlation (r = .33), a sample size of at least 18 in each arm group is required to achieve a power of 0.90, using GPower. The investigators will recruit 20 participants per group expecting attrition.
Procedure
- The study will take place in six sites including assisted living facilities, community centers and adults day centers in Israel.
- Participants will be invited by the research assistance to take part in the study.
- Participants who will be willing to take part in the study will meet with the research team and will read and signed an informed consent form before participating in the study.
- Following the informed consent signing, base line measures will be collected (traits and cognitive measures) (T0).
- Following base line assessment participants will be randomly assigned to four arms. At first, they will randomly assign to one of two conditions (online or face to face). The interactions will be separated in a week. A random half of the two conditions of participants (online and face t face) will be assigned to practice the playful interaction at the first week and control interaction in the second week, whereas for the other half this order will be reversed.
- One designated experiment assigned each participant randomly to one of the two interactions (playful or control), to keep the other experiments blind to the activity.
- For each participant, separate interactions will be conducted by a different experimenter.
- These are the four arms:
- Playful interactions operationalized by dramatic improvisation techniques based on verbal and non-verbal elements in face to face setting
- Playful interactions operationalized by dramatic improvisation techniques based on verbal and non-verbal elements in online setting
- An active control condition that involves introductory conversation and movement exercises in face to face setting in face to face setting
- An active control condition that involves introductory conversation and movement exercises in face to face setting in online setting
- The interventions will meet the following criteria: a) ease of implementation in an online system; b) a short interaction between 15-20 minutes. Both interactions incorporated bodily movement; however, the playful interaction encompassed elements of co-creation, spontaneity, and innovation, whereas the control interaction adhered to a more conventional and routine approach.
- The online interactions will take place using the ZOOM video conference software under laboratory conditions.
- All interactions will be guided by graduate students of the Theatre department at the university of Haifa or drama therapy students or theatre facilitator - the facilitators, who are unfamiliar to the participants. One designated experiment assigned each facilitator randomly to one of the two interactions (playful or control), to keep the other experiments blind to the activity. The facilitators will be randomly assigned to the different interactions, so that for each participants the separate interactions were conducted by a different facilitator.
- All interactions will be videoed recorded. A fidelity check will be done by the research team every week to make sure each participants was given the correct interaction (playful or control), and that each interaction included all phases in the protocol.
- Both interactions will commence with a battery of tests and self-reports before (T1) and after each session (T2). The battery of tests was conducted by an experimenter who will be blind to the type of intervention (playful or control).
- All self-reports and tests will be administered individually in a quiet and well-lighted room before and after each activity. Items will be read aloud to participants when this will be necessary, and responses will be given orally and coded by the researcher. At the end of the initial assessment (T1), participants transitioned to a designated room, equipped with a computer connected to Zoom, or in case of face to face interaction they will meet the facilitator. They will be introduced to the facilitator previously unknown to them and then the experimenter will leave (so they won't be able to know which intervention will be delivered). Each interaction (playful or control) will be administered by a different and unfamiliar experimenter.
- At the end of the interaction, participants reconvene with the primary researcher for the administration of the second assessment (T2). It is important to note that the investigators will take pains to ensure that the experimenter administering the initial and second assessment will be blind to the experimental condition.
Dependent variables
At base line (T0):
- Cognitive tests: forward and backward digit span (WISC III, 1991), phonetic fluency taken (Kave, 2005) from the Hebrew version of the WAIS-IV, ANT attention network test (for younger adults), flanker task (for older adults).
- Traits (openness to experience and extraversion), attachment styles, novelty seeking and social anxiety will be assessed as control variables and for exploratory analysis to investigate sub-populations for whom playful interactions are most beneficial.
Pre interaction (T1)
- Mood Post interaction (T2)
- Cognitive tests
- Mood
- Flow Questionnaire
- Subjective Arousal
- Closeness
- Perceived Partner Responsivness
- Freiburg Mindfulness Inventory
Data analysis
To test the effects of playful interactions in all of the above measures and experiments the investigators use various tools. As the investigators do not wish to assume equality of variance and a normal distribution, they will apply a mixed-level linear model (MLM). The various measures (cognitive, social, and emotional measures) will serve as the dependent variables; age group (young vs. older adults) and platform (online or F2F) as the between-participant variables, and time of testing (before vs. after) and experimental condition (playful interaction vs. control) as the repeated measures. Follow-up analyses will attempt to find connections between the different dependent measures and relate it to the different experimental groups, traits and age groups. This will be done in exploratory mediation and moderation analyses as well as by correlation analysis
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned to four arms. At first they will randomly assign to one of two conditions (online or face to face). On the second and third session the participants will be randomly assigned to a playful or control interaction. The interactions will be separated in a week. A random half of the participants will be assigned to practice the playful interaction at the first week and control interaction in the second week, whereas for the other half this order will be reversed.
| Arm | Type | Receives |
|---|---|---|
| Playful interactions first session in a face-to-face format | Experimental | Behavioral: An active control condition in a face-to-face format, Behavioral: Playful interactions in a face to face formatPlayful interactions operationalized by dramatic improvisation techniques based on verbal and non-verbal elements in a face-to-face format. This arm will take part in the playful interactions in a face-to-face format in the first session and in the active control in the second session |
| An active control condition first session in a face-to-face format | Active comparator | Behavioral: An active control condition in a face-to-face format, Behavioral: Playful interactions in a face to face formatAn active control condition that involves introductory conversation and movement exercises in a face-to-face format. This arm will take part in the active control in a face-to-face format in the first session and in the playful interaction in the second session |
| Playful interactions first session in an online format. | Experimental | Behavioral: Playful interactions in an online format, Behavioral: An active control condition in an online formatPlayful interactions are operationalized by dramatic improvisation techniques based on verbal and non-verbal elements in an online format. This arm will take part in the playful interactions in an online format in the first session and the online active control in the second session |
| An active control condition first session in an online format | Active comparator | Behavioral: Playful interactions in an online format, Behavioral: An active control condition in an online formatAn active control condition that involves introductory conversation and movement exercises in an online format. This arm will take part in the active control in an online format in the first session and in the online playful interaction in the second session. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy cognitive functioning for this age-range with a Mini-Mental State Examination above 24, as reported by the community centers or adult day centers
- No history of auditory or visual pathology, as indicated in a self-report
- No known clinical diagnosis of a major psychiatric disorder or drug/alcohol abuse, as reported by social worker at the community center and self report
- Speaking Hebrew
- Participants who will complete the three study sessions
Key exclusion criteria (5 listed)
- Mini-Mental State Examination beyond 25, as reported by the community centers or adult day centers
- Participants whose responses indicate that they did not follow or did not understand instructions
- Participants with auditory or visual pathology, as indicated in a self-report
- Participants who do not speak Hebrew.
- Participants who will not complete the three study sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Playful interactions in an online formatThe activity is grounded in dramatic improvisation and comprises several games: a ball game, an association game, a mirror game, a movement story game. The intervention will be conducted by zoom | Behavioural | An active control condition first session in an online format, Playful interactions first session in an online format. |
| An active control condition in a face-to-face formatThe activity consisted of three parts: A structured conversation centered around hobbies. In the second part an exercise in words - singular plural. In the third part, participants will be engaged in a movement practice resembling an exercise class. | Behavioural | An active control condition first session in a face-to-face format, Playful interactions first session in a face-to-face format |
| An active control condition in an online formatThe activity consisted of three parts: A structured conversation centered around hobbies. In the second part an exercise in words - singular plural. In the third part, participants will be engaged in a movement practice resembling an exercise class. The intervention will be conducted conducted by zoom | Behavioural | An active control condition first session in an online format, Playful interactions first session in an online format. |
| Playful interactions in a face to face formatThe activity is grounded in dramatic improvisation and comprises several games: a ball game, an association game, a mirror game, a movement story game. | Behavioural | An active control condition first session in a face-to-face format, Playful interactions first session in a face-to-face format |
Primary outcome
Digit span
Time frame: (1) Base line (2) one week following baseline and immediately after the first interaction (3) two weeks following baseline and immediately after the second interaction
Digit Span test. consists of two stages (WISC III, 1991): a) Forward Digit Span to evaluate short-term memory. b) Backward Digit Span to assess working memory.
Phonetic fluency
Time frame: (1) Base line (2) one week following baseline and immediately after the first interaction (3) two weeks following baseline and immediately after the second interaction
Phonetic fluency taken (Kave, 2005) from the Hebrew version of the WAIS-IV,
Flanker task
Time frame: (1) Base line (2) one week following baseline and immediately after the first interaction (3) two weeks following baseline and immediately after the second interaction
(Fan et al., 2005, 2009) attention - response time for correct answers
Perceived Partner Responsiveness
Time frame: (1) Base line (2) one week following baseline and immediately after the first interaction (3) two weeks following baseline and immediately after the second interaction
Perceived Partner Responsiveness (Reis et al. 2017). A 4-item questionnaire will asses how one partner perceived the other. It will enable us to assess a relationship's development after these short interactions between unfamiliar partners.
Closeness
Time frame: (1) one week following baseline and immediately after the first interaction (2) two weeks following baseline and immediately after the second interaction
was measured using a 3-item questionnaire found in Golland et al., 2019). Participants rated the degree to which they felt closeness, similarity and rapport towards the experimenter during the interaction toward the experimenter on a seven-point Likert scale from 1 (strongly disagree) to 5 (strongly agree): "During the experiment, I felt that I became closer to the other participant?".
Mood
Time frame: (1) Base line (2) one week following baseline, before and immediately after the first interaction (3) two weeks following baseline, before and immediately after the second interaction
Mood will be assessed on the Positive and Negative Affect Schedule (Watson et al., 2008), a self-report inventory divided into two subscales assessing positive and negative affect. The inventory consists of 10 items for each subscale, scored on a scale ranging from 1 (very slightly or not at all) to 5 (extremely).
3 secondary outcomes
Flow
Time frame: (1) one week following baseline and immediately after the first interaction (2) two weeks following baseline and immediately after the second interaction
Mindfulness
Time frame: (1) one week following baseline and immediately after the first interaction (2) two weeks following baseline and immediately after the second interaction
Subjective Arousal
Time frame: (1) Base line (2) one week following baseline, before and immediately after the first interaction (3) two weeks following baseline, before and immediately after the second interaction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: Yes. On upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Playful interactions in an online format and Playful interactions in a face to face format in people with Aging and Cognitive Function 1, Social, run by University of Haifa at 4 sites 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 6 inclusion and 5 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Digit span (time frame: (1) Base line (2) one week following baseline and immediately after the first interaction (3) two weeks following baseline and immediately after the second interaction). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.