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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04398472
Other study ID # ND01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 7, 2020
Est. completion date January 1, 2021

Study information

Verified date April 2021
Source Swinburne University of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There is ample evidence showing that loneliness is a public health problem that influences social, mental and physical health. The current project is about evaluating the effectiveness of the Kindness Is NextDoor (KIND) Challenge, a social networking platform aimed at reducing loneliness and social isolation in specific Nextdoor communities within Australia. As the landscape through which people make social connections changes due to technology it is important to evaluate the effectiveness of platforms that are designed to reduce loneliness within communities. This is the first study of its kind in Australia and will help provide insight into how to target social isolation and loneliness within communities using social networking platforms.


Recruitment information / eligibility

Status Completed
Enrollment 4500
Est. completion date January 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
KIND Challenge
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.

Locations

Country Name City State
Australia Swinburne University of Technology Hawthorn

Sponsors (4)

Lead Sponsor Collaborator
Swinburne University of Technology Brigham Young University, University of Manchester, University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in loneliness as measured by UCLA Loneliness Scale - Version 3 (UCLA-LS; Russell, 1996). 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 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). 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
Secondary Change in depression as measured by Patient Health Questionnaire-8 (PHQ-8; Kroenke & Spitzer, 2002). 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
Secondary Change in social anxiety as measured by Mini-Social Phobia Inventory (Mini-SPIN; Connor, Kobak, Churchill, Katzelnick, & Davidson, 2001). 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
Secondary Change in perceived stress as measured by Perceived Stress Scale-4 (PSS-4; Cohen, Williamson, Spacapan, & Oskamp, 1988). 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
Secondary 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) 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
Secondary Change in social cohesion and community trust as measured by the Social Capital Scale (Martin, Rogers, Cook, & Joseph, 2004). 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
Secondary Neighbourhood perception of change 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
Secondary Neighbourhood importance 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
Secondary Neighbourhood modified Social Relationship Index 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
Secondary Neighbourhood conflict 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
Secondary Neighbourhood number of contacts 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
Secondary Acceptability 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
Secondary Feasibility of the Challenge Feasibility will be assessed by a high retention rate (i.e., <40% drop-out). 4 weeks for challenge condition, 8 weeks for waitlist
Secondary Change in social isolation risk as measured by Lubben Social Network Scale (LSNS; Lubben & Gironda, 2003). 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
Secondary Safety of the KIND Challenge 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
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