NCT06081725

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

September 29, 2023

Last Update Submit

February 17, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    (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,

    (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

    (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.

    (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?".

    (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).

    (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

    (1) one week following baseline and immediately after the first interaction (2) two weeks following baseline and immediately after the second interaction

  • Mindfulness

    (1) one week following baseline and immediately after the first interaction (2) two weeks following baseline and immediately after the second interaction

  • Subjective Arousal

    (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

Study Arms (4)

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

Behavioral: An active control condition in a face-to-face formatBehavioral: 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

Behavioral: An active control condition in a face-to-face formatBehavioral: 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

Behavioral: Playful interactions in an online formatBehavioral: 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.

Behavioral: Playful interactions in an online formatBehavioral: An active control condition in an online format

Interventions

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 first session in an online formatPlayful interactions first session in an online format.

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 first session in a face-to-face formatPlayful interactions first session in a face-to-face format

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

An active control condition first session in an online formatPlayful interactions first session in an online format.

The activity is grounded in dramatic improvisation and comprises several games: a ball game, an association game, a mirror game, a movement story game.

An active control condition first session in a face-to-face formatPlayful interactions first session in a face-to-face format

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beit-horim

Haifa, 3498838, Israel

Location

Beit Avraham - Sephardic community

Haifa, Israel

Location

Uziel community center for the aging population

Ramat Gan, Israel

Location

Kibutz Givat Brenner

Rehovot, Israel

Location

MeSH Terms

Conditions

Social Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
One designated experiment assigned each participant randomly to one of the interactions (playful or control), to keep the other experiments blind to the activity.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 13, 2023

Study Start

January 20, 2023

Primary Completion

October 5, 2023

Study Completion

October 5, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

On upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
One year after publication
Access Criteria
Upon request.

Locations