- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06081725
Playfulness in Online and Face-to-face Interactions, From Adulthood to Aging (Play)
Playfulness in Online and Face-to-face Interactions, From Adulthood to Aging: Physiological, Cognitive, and Emotional Mechanisms and Outcomes
Study Overview
Status
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Haifa, Israel, 3498838
- Beit-horim
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Haifa, Israel
- Beit Avraham - Sephardic community
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Ramat Gan, Israel
- Uziel community center for the aging population
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Reẖovot, Israel
- Kibutz Givat Brenner
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Playful interactions first session in a face-to-face format
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
|
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 activity is grounded in dramatic improvisation and comprises several games: a ball game, an association game, a mirror game, a movement story game.
|
Active Comparator: An active control condition first session in a face-to-face format
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
|
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 activity is grounded in dramatic improvisation and comprises several games: a ball game, an association game, a mirror game, a movement story game.
|
Experimental: Playful interactions first session in an online format.
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
|
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
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
|
Active Comparator: An active control condition first session in an online format
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.
|
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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
(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
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,
|
(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
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
|
(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
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.
|
(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
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?".
|
(1) one week following baseline and immediately after the first interaction (2) two weeks following baseline and immediately after the second interaction
|
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).
|
(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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
(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
|
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.
|
(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
|
Subjective Arousal with one item will be measured using a 9-point scale
|
(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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 181/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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