- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04398472
Evaluation of the Nextdoor KIND Challenge
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hawthorn, Australia
- Swinburne University of Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Community dwellers who use the Nextdoor platform.
- Aged 18 to 90 years old.
Exclusion Criteria:
- Individual's without proficient English reading comprehension skills will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Waitlist
|
|
Active Comparator: Challenge
Participants in the challenge will be asked to complete four activities over the next four weeks to address loneliness and social isolation in their communities. The activities will involve doing an activity with people in their neighbourhood. These activities have been selected based on being positive, engaging and feasible to the average individuals. An example of the type of activities is having a conversation with a neighbour on the phone or via video chat and safely checking in on someone who is elderly or living alone. All activities will adhere to the relevant country or states health department's safety recommendations and laws during COVID-19. Hypothesis 1 (H1). There will be a reduction in the primary outcome, loneliness in participants assigned to the Nextdoor KIND Challenge groups compared to the waitlist control group post the 4-week intervention |
The KIND challenge consists of nominating an activity to complete over a 4 week period.
The activities involve doing an activity with others in your neighbourhood.
These activities are positive, engaging and feasible to the average individual.
Activities adhere to relevant country or state department health and safety guidelines.
For example; having a chat with a neighbour online, or bringing in rubbish bins for an elderly neighbour.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in loneliness as measured by UCLA Loneliness Scale - Version 3 (UCLA-LS; Russell, 1996).
Time Frame: Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 times points: baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
The UCLA-LS is a 20-item measure employing a 1 (Never) to 4 (Always) Likert-type scale.
The measure consists of both positively- and negatively-worded items that assess loneliness (e.g., How often do you feel that you are no longer close to anyone?).
The UCLA-LS has been shown to correlate negatively with life satisfaction and perceived social support, thus supporting its convergent validity with related constructs.
The range of possible scores is from 0-80 where higher scores indicate higher levels of loneliness.
|
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 times points: baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life as measured by European Health Interview Survey-Quality Of Life - 8-Item Index (EUROHIS-QOL-8; Power, 2003; Schmidt, Mühlan, & Power, 2005).
Time Frame: Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
The EUROHIS-QOL-8 is an 8-item measure of quality of life consisting of questions that assess overall QOL, general health, energy, daily living activity, self-esteem, social relationships, finances and home.
The measure is derived from the WHOQOL-BREF and shares a similar 5-point Likert-scale response format.
The scale has demonstrated good qualities in term of internal consistency (Cronbach's alpha = 0.83) and satisfactory convergent and discriminant validity (Schmidt et al., 2005).
The range of possible scores is 8-40 where higher scores indicate higher quality of life.
|
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
Change in depression as measured by Patient Health Questionnaire-8 (PHQ-8; Kroenke & Spitzer, 2002).
Time Frame: Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
The PHQ-8 is an 8-item measure of depression severity based on 8 of the 9 item criteria of the DSM-IV.
The measure was derived from the PHQ-9 however; the ninth question was omitted from this study as depression was not a primary outcome.
Depression severity is scored based on the presence of depressive symptomology in the previous 2 weeks of measure admission.
The scale uses a 1 (not at all) to 4 (nearly every day) Likert scale with higher scores indicating higher levels of depressive symptomology.
The range of possible scores is 8-32.
The PHQ-9 has been shown to have good criterion and construct validity and excellent internal consistency (Kroenke, Spitzer, & Williams, 2001).
The PHQ-8 shares similar properties in terms of validity and reliability and is therefore an adequate alternative to its 9-item scale counterpart (Kroenke & Spitzer, 2002).
|
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
Change in social anxiety as measured by Mini-Social Phobia Inventory (Mini-SPIN; Connor, Kobak, Churchill, Katzelnick, & Davidson, 2001).
Time Frame: Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
The Mini-SPIN is a brief 3-item measure of generalised social anxiety disorder.
The measure employs a 5-point Likert scale form 1 (not at all) to 5 (extremely), with higher scores indicating a greater level of generalised social anxiety.
The range of possible scores is 3-15.
The Mini-SPIN has shown high sensitivity in detecting social anxiety disorder (Connor et al., 2001).
|
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
Change in perceived stress as measured by Perceived Stress Scale-4 (PSS-4; Cohen, Williamson, Spacapan, & Oskamp, 1988).
Time Frame: Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
This four-item measure of stress was derived from the original 14-item Perceived Stress Scale (PSS).
This measure consists of both positively and negatively worded items that asses an individual's evaluation of stressful events.
The measure employs a 5-point Likert scale ranging from 0 (never) to 4 (very often).
The range of possible scores is 0-16 where higher scores indicate higher levels of perceived stress.
The PSS-4 has been shown to negatively correlate with levels of perceived health, social support, being male, and older age (Warttig, Forshaw, South, & White, 2013).
The scale has demonstrated fair reliability and adequate psychometric properties (Warttig et al., 2013).
|
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
Change in positive and negative affect as measured by The Positive and Negative Affect Schedule-Short Form (PANAS-SF 10 item; Watson, Clark, & Tellegen, 1988)
Time Frame: Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
The PANAS-SF is a 10-item short form version of the Positive and Negative Affect Scale scale.
The measure asks respondents to rate the extent to which they feel a particular emotion along a 5-point Likert scale ranging from 1 (very slightly) to 5 (extremely).
The range of possible scores is 5-25 for each subscale (positive affect and negative affect) where higher scores indicate higher levels of positive or negative affect.
This subscale measure has been shown to have high levels of internal consistency (Watson et al., 1988) and acceptable levels of convergent validity (Roesch, 1998).
|
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
Change in social cohesion and community trust as measured by the Social Capital Scale (Martin, Rogers, Cook, & Joseph, 2004).
Time Frame: Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
The Social Capital Scale is a 7-item measure designed to assess social cohesion and trust in a community.
The scale was derived from a similar scale used in Sampson, Raudenbush, and Earls (1997).
This measure consists of both positively and negatively worded items and is recorded on a 2 point Likert scale ranging form 0 (strongly disagree or disagree) to 1 (strongly Agree or agree).
The range of possible scores is 0-14 where higher scores indicate higher levels of social cohesion and trust.
This measure was shown to be a reliable tool to measure social cohesion and trust at a neighbourhood level (Sampson et al., 1997).
|
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
Neighbourhood perception of change
Time Frame: Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
This question asks if participants thought their neighbourhood was improving from 1 (improving) to 3 (declining).
|
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
Neighbourhood importance
Time Frame: Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
This question asks how important participants thought it was to know their neighbours from 1 (very important) to 5 (very important)
|
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
Neighbourhood modified Social Relationship Index
Time Frame: Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
The 3-item scale was modified from the Social Relationship Index (34).
Three factors measuring support, ambivalence, and aversive.
We ask how participants feel towards their neighbours when needing advice, understanding, or a favour - helpfulness, upsetting, mixed/conflicted feelings on a Likert scale from 1 (not at all) to 6 (extremely).
|
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
Neighbourhood conflict
Time Frame: Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
Participants will be asked to reflect on their interactions with their neighbours in the past month using a dichotomous yes/no to the following: absence/presence of neighbour conflict, critical comments towards the participant, participant critical of neighbours.
|
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
Neighbourhood number of contacts
Time Frame: Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
This item asks the number of people the participants knows in their neighbourhood, 0 (0-5 neighbours) to 4 (15+ neighbours).
|
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
Acceptability
Time Frame: 4 weeks for challenge condition, 8 weeks for waitlist
|
We measured acceptability around these factors, including how connected (1 not at all connected to 10 very connected), how meaningful was the activity (1 not very meaningful to 10 very meaningful), how safe they felt when completing the challenge (1 not very safe to 10 very safe), how positive they felt (1 not very positive to 10 very positive), how comfortable they felt doing the activity (1 not at all comfortable to 10 very comfortable).
It is anticipated that the Nextdoor KIND challenge will yield ratings of more than 5 indicating higher levels of acceptability across these outcomes.
|
4 weeks for challenge condition, 8 weeks for waitlist
|
Feasibility of the Challenge
Time Frame: 4 weeks for challenge condition, 8 weeks for waitlist
|
Feasibility will be assessed by a high retention rate (i.e., <40% drop-out).
|
4 weeks for challenge condition, 8 weeks for waitlist
|
Change in social isolation risk as measured by Lubben Social Network Scale (LSNS; Lubben & Gironda, 2003).
Time Frame: Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
The LSNS is an 18-item scale that assesses the frequency and quality of contact - such as talking about private matters - in an individual's network.
There are three subscales and each consists of 6 items relating to family, neighbour and friend connections.
The scale employs a 0 (none) to 5 (nine or more) Likert scale and includes 6 items (eg.
How many relatives do you see or hear from at least once a month?).
Higher scores indicate larger social networks and lower risk of social isolation.
The scale has demonstrated adequate levels of reliability and the proposed clinical cut-points showed good convergent validity (Lubben & Gironda, 2003).
The range of possible scores is from 0-90 where higher scores indicate more social connections and lower risk of social isolation.
|
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
|
Safety of the KIND Challenge
Time Frame: Challenge: 4 weeks from baseline Waitlist: 8 weeks from baseline
|
We assess for unintended harms (e.g., conflict) during this period.
In this case, we measure the occurrence of neighbour conflict with a single dichotomous item, 'Did you have a conflict with a neighbour because of the KIND challenge'.
This item is measured with a yes or no response.
|
Challenge: 4 weeks from baseline Waitlist: 8 weeks from baseline
|
Collaborators and Investigators
Publications and helpful links
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
- ND01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Loneliness
-
University of RochesterNational Institute on Aging (NIA)Recruiting
-
Vladimíra DostálováBarcelona Institute for Global HealthRecruiting
-
Taipei Medical UniversityCompleted
-
Linkoeping UniversityUniversity College, LondonCompleted
-
KTO Karatay UniversityCompleted
-
Florida State UniversityCompleted
-
Heartfulness InstituteCompletedLonelinessUnited States
-
Trustees of Dartmouth CollegeRecruiting
-
University of OregonNational Institute on Drug Abuse (NIDA); HopeLab FoundationCompleted
Clinical Trials on KIND Challenge
-
University of California, Los AngelesRecruitingDepression | Child AnxietyUnited States
-
University Hospital, GhentCompletedPregnancy Related | Placenta, Retained | Placenta; Retention, Fragments, Complicating Puerperium, Without Hemorrhage | Placenta; Retention, Fragments, Complicating Puerperium (Delayed Hemorrhage) | Hysteroscopy / Methods | Retrospective Studies | Vacuum CurettageBelgium
-
University of WashingtonUniversity of Washington Institute for Translational Health Science (UL1...Completed
-
Franciscan University CenterCompletedGingival Abrasion | Biofilm RemovalBrazil
-
Enrique Ordiñaga-Monreal, OD, MScUnknownAstigmatism | Visual Acuity | IOL | Cataract AfterSpain
-
Federation Francophone de Cancerologie DigestiveTerminatedMetastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine TumoursFrance, Belgium, Germany, United Kingdom
-
Merck Sharp & Dohme LLCCompleted
-
University of Turin, ItalyCompletedHyperglycemia | Insulin Sensitivity
-
Lund UniversityFood for Health Science Centre, Lund UniversityCompleted
-
China Academy of Chinese Medical SciencesChina Food and Drug AdministrationCompleted