NCT05373121

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 7, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

May 9, 2022

Last Update Submit

September 11, 2023

Conditions

LonelinessAnxietyAnxiety DisorderDepressionLow Mood

Keywords

randomised controlled triallonelinesspeer supportonline peer supportlong-term conditionchronic illnessparenting

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Social Capital

    Measured at baseline (time 1), post (3 months - time 2), follow up (6 months - time 3)

  • Anxiety and Depression

    Measured at baseline (time 1), post (3 months - time 2), follow up (6 months - time 3)

Study Arms (2)

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.

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.

Interventions

Online Peer SupportBEHAVIORAL

Signposting to online peer support groups and forums

Intervention condition - signposting to online peer support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- participants must not be under 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College, London

London, WC1H 0BT, United Kingdom

Location

Related Publications (10)

  • 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.

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 33413141BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 30514104BACKGROUND

  • 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.

    PMID: 25218734BACKGROUND

  • 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.

    BACKGROUND

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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 34286652BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepressionConsciousness DisordersChronic Disease

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersDisease AttributesPathologic Processes

Study Officials

  • Sophie Bennett

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 13, 2022

Study Start

July 7, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Access Criteria
Data will be available on reasonable request

Locations

GB(1)