LonelinessNCT05373121
Is Signposting to Online Peer Support Helpful in Decreasing Loneliness in Parents of Children With Long-term Conditions and Disabilities?
A study testing Online Peer Support in people with Loneliness and Anxiety, run by University College, London at 1 site in United Kingdom.
Trial summary
The present study aims to evaluate whether signposting to online peer support will be associated with a significant decrease in self-reported loneliness for parents of children with long-term conditions and disabilities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Anxiety, Anxiety Disorder
- What is being tested?
- Online Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jul 2022to 31 Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants will be required to have one or more child with long-term conditions or disabilities
- participants must consent to take part
- participants should be sufficiently fluent in English to enable participation in online peer support groups and forums as well as participation in the study.
Who cannot join
- participants must not be under 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Signposting to Online Peer Support Helpful in Decreasing Loneliness in Parents of Children With Long-term Conditions and Disabilities? A Randomised Controlled Trial
The present study aims to evaluate whether signposting to online peer support will be associated with a significant decrease in self-reported loneliness for parents of children with long-term conditions and disabilities. Parents of children with long-term conditions and disabilities will be randomised to either the treatment condition, being signposted to online peer support, or to the waitlist condition. Whether signposting to online peer support has an impact on social capital and anxiety and depression will also be investigated.
Read the detailed description
Loneliness has been defined as an aversive subjective experience that occurs when a person's social network is lacking in either quality or quantity compared to their needs. A recent poll of 2000 parents found that more than half had experienced a problem with loneliness.
There is ample evidence that parental loneliness has negative consequences for both the parent and child. Loneliness has been associated with parental stress, with maternal loneliness being associated with dissatisfaction with life and the couple relationship and depressive symptoms, and found to be a predictor of chronic depression. Paternal loneliness has been shown to predict son's loneliness, and daughter's loneliness is predicted by maternal loneliness. Additionally, maternal loneliness has been found to predict social competence and fear of negative evaluation in adolescents.
Social capital, which has been defined as the creation of personal relationships and the benefits that come with them, has been found to be significantly inversely associated with loneliness in different populations, for example older adults and students.
A recent scoping review found that parents of children with long-term conditions or disabilities appear to be at increased risk of loneliness, but there has been little research looking directly at what might help to alleviate loneliness in this group. The review identified that peer support could be a potential key mechanism in reducing loneliness in parents.
With stretched mental health services for families in the UK, parents are often signposted to peer support groups for advice and support. Due to the COVID-19 pandemic many face-to-face peer support groups have been forced to close, with signposting options being limited to online peer support groups or forums.
The primary aim of the study is to evaluate the effectiveness of signposting parents of children with long-term conditions and disabilities to peer support groups in terms of alleviating loneliness (relative to a wait list control). A secondary aim is to identify the predictors of such change / any response to allocation to the peer support groups, including attendance of the peer support and changes in online and offline social capital. Whether signposting to online peer support has an impact on anxiety and depression will also be investigated.
- Conditions
- Loneliness, Anxiety, Anxiety Disorder, Depression, Low Mood
- Being tested
- Online Peer Support
- Keywords
- randomised controlled trial, loneliness, peer support, online peer support, long-term condition, chronic illness, parenting
- Medical subject headings
- Anxiety Disorders, Depression, Consciousness Disorders, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Peer SupportBehavioural
Signposting to online peer support groups and forums
| Study group | Role | What they receive |
|---|---|---|
| Intervention condition - signposting to online peer support | Experimental | The intervention group will be sent a list of online peer support signposting groups and forums to engage with, which will be adapted depending on what health conditions their child has. They will be asked to keep a weekly engagement log for three months. Receives: Behavioral: Online Peer Support |
| Waitlist condition | No intervention | The waitlist group will be informed that they will be contacted again in three months, after which, the waitlist will be sent the signposting resources. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness
Change in self-reported loneliness on the 20-item revised UCLA Loneliness Scale (R-UCLA: Russell, Peplau, \& Cutrona, 1980). Scores range from 20 to 80, with higher scores indicating a higher level of self-reported loneliness.
Measured: Measured at baseline (time 1), post (3 months - time 2), follow up (6 months - time 3)
Secondary outcomes (2)
Social Capital
Change in self-reported social capital (online and offline) on the Williams' (2006) Internet Social Capital scale. Scores range from 10 to 50 on each subscale (online and offline), with higher scores indicating a higher level of self-reported social capital
Measured: Measured at baseline (time 1), post (3 months - time 2), follow up (6 months - time 3)
Anxiety and Depression
Change in self-reported anxiety and depression on the Hospital Anxiety and Depression Scale (Zigmond \& Snaith, 1983). Scores range from 0-21 on each subscale (depression and anxiety), with higher scores indicating a higher level of self-reported anxiety or depression symptoms.
Measured: Measured at baseline (time 1), post (3 months - time 2), follow up (6 months - time 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start7 Jul 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Bennett, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373121
- Sponsor's protocol ID
- 22125/001
- Status last verified
- Sep 2023
- First submitted
- 9 May 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be stored indefinitely on a secure UCL database and may be used for future research, it will not be identifiable to you in any way.
Publications
Au A, Chan YC, Cheung G, Yuen P, Lee T. Examining the correlation between parenting stress and social support and loneliness in Chinese mothers living in a socially impoverished community in Hong Kong. Journal of Psychology in Chinese Societies. 2008 Jul 1;9(2):167.
Action for Children. It starts with hello: A report into the impact of loneliness in children, young people and families. London; 2017
Bai Z, Wang Z, Shao T, Qin X, Hu Z. Association between social capital and loneliness among older adults: a cross-sectional study in Anhui Province, China. BMC Geriatr. 2021 Jan 7;21(1):26. doi: 10.1186/s12877-020-01973-2.
PubMed 33413141Perlman D, Peplau LA. Loneliness research: A survey of empirical findings. Preventing the harmful consequences of severe and persistent loneliness. 1984;13:46.
Luoma I, Korhonen M, Puura K, Salmelin RK. Maternal loneliness: concurrent and longitudinal associations with depressive symptoms and child adjustment. Psychol Health Med. 2019 Jul;24(6):667-679. doi: 10.1080/13548506.2018.1554251. Epub 2018 Dec 5.
PubMed 30514104Luoma I, Korhonen M, Salmelin RK, Helminen M, Tamminen T. Long-term trajectories of maternal depressive symptoms and their antenatal predictors. J Affect Disord. 2015 Jan 1;170:30-8. doi: 10.1016/j.jad.2014.08.017. Epub 2014 Aug 30.
PubMed 25218734Salo AE, Junttila N, Vauras M. Social and emotional loneliness: Longitudinal stability, interdependence, and intergenerational transmission among boys and girls. Family Relations. 2020 Feb;69(1):151-65.
Zafar N, Kausar R. Psychosocial implications of early father separation for adolescents and their mothers. Age. 2015;47(5).
Williams D. On and off the'Net: Scales for social capital in an online era. Journal of computer-mediated communication. 2006 Jan 1;11(2):593-628.
Nowland R, Thomson G, McNally L, Smith T, Whittaker K. Experiencing loneliness in parenthood: a scoping review. Perspect Public Health. 2021 Jul;141(4):214-225. doi: 10.1177/17579139211018243.
PubMed 34286652
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Signposting to Online Peer Support Helpful in Decreasing Loneliness in Parents of Children With Long-term Conditions and Disabilities? A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05373121
- Acronym / sponsor ID
- 22125/001
- Conditions
- Loneliness, Anxiety, Anxiety Disorder, Depression, Low Mood
- Keywords
- randomised controlled trial, loneliness, peer support, online peer support, long-term condition, chronic illness, parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 13 May 2022 (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.
The present study aims to evaluate whether signposting to online peer support will be associated with a significant decrease in self-reported loneliness for parents of children with long-term conditions and disabilities. Parents of children with long-term conditions and disabilities will be randomised to either the treatment condition, being signposted to online peer support, or to the waitlist condition. Whether signposting to online peer support has an impact on social capital and anxiety and depression will also be investigated.
Detailed description
Loneliness has been defined as an aversive subjective experience that occurs when a person's social network is lacking in either quality or quantity compared to their needs. A recent poll of 2000 parents found that more than half had experienced a problem with loneliness.
There is ample evidence that parental loneliness has negative consequences for both the parent and child. Loneliness has been associated with parental stress, with maternal loneliness being associated with dissatisfaction with life and the couple relationship and depressive symptoms, and found to be a predictor of chronic depression. Paternal loneliness has been shown to predict son's loneliness, and daughter's loneliness is predicted by maternal loneliness. Additionally, maternal loneliness has been found to predict social competence and fear of negative evaluation in adolescents.
Social capital, which has been defined as the creation of personal relationships and the benefits that come with them, has been found to be significantly inversely associated with loneliness in different populations, for example older adults and students.
A recent scoping review found that parents of children with long-term conditions or disabilities appear to be at increased risk of loneliness, but there has been little research looking directly at what might help to alleviate loneliness in this group. The review identified that peer support could be a potential key mechanism in reducing loneliness in parents.
With stretched mental health services for families in the UK, parents are often signposted to peer support groups for advice and support. Due to the COVID-19 pandemic many face-to-face peer support groups have been forced to close, with signposting options being limited to online peer support groups or forums.
The primary aim of the study is to evaluate the effectiveness of signposting parents of children with long-term conditions and disabilities to peer support groups in terms of alleviating loneliness (relative to a wait list control). A secondary aim is to identify the predictors of such change / any response to allocation to the peer support groups, including attendance of the peer support and changes in online and offline social capital. Whether signposting to online peer support has an impact on anxiety and depression will also be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention condition - signposting to online peer support | Experimental | Behavioral: Online Peer SupportThe intervention group will be sent a list of online peer support signposting groups and forums to engage with, which will be adapted depending on what health conditions their child has. They will be asked to keep a weekly engagement log for three months. |
| Waitlist condition | No intervention | –The waitlist group will be informed that they will be contacted again in three months, after which, the waitlist will be sent the signposting resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- participants will be required to have one or more child with long-term conditions or disabilities
- participants must consent to take part
- participants should be sufficiently fluent in English to enable participation in online peer support groups and forums as well as participation in the study.
Key exclusion criteria (1 listed)
- participants must not be under 18 years of age.
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 |
|---|---|---|
| Online Peer SupportSignposting to online peer support groups and forums | Behavioural | Intervention condition - signposting to online peer support |
Primary outcome
Loneliness
Time frame: Measured at baseline (time 1), post (3 months - time 2), follow up (6 months - time 3)
Change in self-reported loneliness on the 20-item revised UCLA Loneliness Scale (R-UCLA: Russell, Peplau, \& Cutrona, 1980). Scores range from 20 to 80, with higher scores indicating a higher level of self-reported loneliness.
2 secondary outcomes
Social Capital
Time frame: Measured at baseline (time 1), post (3 months - time 2), follow up (6 months - time 3)
Anxiety and Depression
Time frame: Measured at baseline (time 1), post (3 months - time 2), follow up (6 months - time 3)
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 13 Sep 2023.
- BackgroundAu A, Chan YC, Cheung G, Yuen P, Lee T. Examining the correlation between parenting stress and social support and loneliness in Chinese mothers living in a socially impoverished community in Hong Kong. Journal of Psychology in Chinese Societies. 2008 Jul 1;9(2):167.
- BackgroundAction for Children. It starts with hello: A report into the impact of loneliness in children, young people and families. London; 2017
- Background: PubMed 33413141Bai Z, Wang Z, Shao T, Qin X, Hu Z. Association between social capital and loneliness among older adults: a cross-sectional study in Anhui Province, China. BMC Geriatr. 2021 Jan 7;21(1):26. doi: 10.1186/s12877-020-01973-2.
- BackgroundPerlman D, Peplau LA. Loneliness research: A survey of empirical findings. Preventing the harmful consequences of severe and persistent loneliness. 1984;13:46.
- Background: PubMed 30514104Luoma I, Korhonen M, Puura K, Salmelin RK. Maternal loneliness: concurrent and longitudinal associations with depressive symptoms and child adjustment. Psychol Health Med. 2019 Jul;24(6):667-679. doi: 10.1080/13548506.2018.1554251. Epub 2018 Dec 5.
- Background: PubMed 25218734Luoma I, Korhonen M, Salmelin RK, Helminen M, Tamminen T. Long-term trajectories of maternal depressive symptoms and their antenatal predictors. J Affect Disord. 2015 Jan 1;170:30-8. doi: 10.1016/j.jad.2014.08.017. Epub 2014 Aug 30.
- BackgroundSalo AE, Junttila N, Vauras M. Social and emotional loneliness: Longitudinal stability, interdependence, and intergenerational transmission among boys and girls. Family Relations. 2020 Feb;69(1):151-65.
- BackgroundZafar N, Kausar R. Psychosocial implications of early father separation for adolescents and their mothers. Age. 2015;47(5).
- BackgroundWilliams D. On and off the'Net: Scales for social capital in an online era. Journal of computer-mediated communication. 2006 Jan 1;11(2):593-628.
- Background: PubMed 34286652Nowland R, Thomson G, McNally L, Smith T, Whittaker K. Experiencing loneliness in parenthood: a scoping review. Perspect Public Health. 2021 Jul;141(4):214-225. doi: 10.1177/17579139211018243.
- Individual participant dataSharing planned: Yes. Anonymised data will be stored indefinitely on a secure UCL database and may be used for future research, it will not be identifiable to you in any way.
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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.
Sophie Bennett principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Peer Support in people with Loneliness and Anxiety, run by University College, London at 1 site in United Kingdom.
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 3 inclusion and 1 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Loneliness (time frame: Measured at baseline (time 1), post (3 months - time 2), follow up (6 months - time 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05373121, which also lists 10 linked publications.
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 13 Sep 2023.