Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05373121
Other study ID # 22125/001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 7, 2022
Est. completion date August 31, 2023

Study information

Verified date September 2023
Source University College, London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - 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. Exclusion criteria: - participants must not be under 18 years of age.

Study Design


Intervention

Behavioral:
Online Peer Support
Signposting to online peer support groups and forums

Locations

Country Name City State
United Kingdom University College, London London

Sponsors (1)

Lead Sponsor Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

Action for Children. It starts with hello: A report into the impact of loneliness in children, young people and families. London; 2017

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.

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. — View Citation

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. — View Citation

Luoma 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. — View Citation

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. — View Citation

Perlman D, Peplau LA. Loneliness research: A survey of empirical findings. Preventing the harmful consequences of severe and persistent loneliness. 1984;13:46.

Salo 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.

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.

Zafar N, Kausar R. Psychosocial implications of early father separation for adolescents and their mothers. Age. 2015;47(5).

Outcome

Type Measure Description Time frame Safety issue
Primary 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 at baseline (time 1), post (3 months - time 2), follow up (6 months - time 3)
Secondary 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 at baseline (time 1), post (3 months - time 2), follow up (6 months - time 3)
Secondary 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 at baseline (time 1), post (3 months - time 2), follow up (6 months - time 3)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A