NCT05620368

Brief Summary

The main objective of this study is to evaluate the effectiveness of an eight-week mindfulness-based teleintervention in improving quality of life, parental burnout, self-compassion, and stress level in mothers of children with disabilities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

October 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 20, 2023

Status Verified

December 1, 2022

Enrollment Period

1.3 years

First QC Date

November 9, 2022

Last Update Submit

March 17, 2023

Conditions

Keywords

parental burnoutmeditationmindfulnessself-compassionstress levelparents of children with disabilityautismquality of life

Outcome Measures

Primary Outcomes (1)

  • Families in Early Intervention Quality of Life (FEIQoL)

    Families in Early Intervention Quality of Life (FEIQoL) questionnaire will be used for assessing the quality of life. Participants answer 40 items using a five-point Likert scale (1, 'poor' to 5, 'excellent') in the aspects of family life (24 items), and child's functioning (16 items).

    15 minutes

Secondary Outcomes (4)

  • Parental Burnout Measure (PBM-12)

    7 minutes

  • Self-Compassion Scale (SCS)

    7 minutes

  • Perceived Stress Scale (PSS-10)

    7 minutes

  • Ego Resilience Scale (ER89)

    7 minutes

Study Arms (2)

Mindfulness-based teleintervention

EXPERIMENTAL

8-week Mindfulness and Compassionate Living Course (MCLC). The course will be held online (using the Zoom platform) with weekly sessions lasting 2.5 hours each, as well as a day of silent practice (mini-retreat of 4 hours).

Behavioral: Mindfulness and Compassionate Living Course (MCLC)

Usual care intervention

ACTIVE COMPARATOR

The facility provides psychological support for parents as needed and at the request of the parent. Support includes individual support of a psychologist (1h / week), consultation with a teacher (special pedagogue and early school education teacher, 1h / week), individual consultation with observation of a child with a Venetian mirror (1h / week).

Behavioral: Usual care intervention

Interventions

The course will be held online (using the Zoom platform) with weekly sessions lasting 2.5 hours each, as well as a day of silent practice (mini-retreat of 4 hours) between sessions 6 and 7. On the structural level, every course session consists of four elements: (1) an educational input, (2) mindfulness and compassion exercises (eg, sitting meditation, body scan, mindful walking, self-compassion break), (3) a reflection of one's practice (inquiry), (4) and home assignments.

Mindfulness-based teleintervention

If necessary, psychological support is organized at the request of the parent. Support includes individual support of a psychologist (1h / week), consultation with a teacher (special pedagogue and early school education teacher, 1h / week), individual consultation with observation of a child with a Venetian mirror (1h / week).

Usual care intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • mother of childern with disabilities

You may not qualify if:

  • substance abuse;
  • participation in another therapeutic project or individual psychotherapy;
  • antidepressant treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Wroclaw University of Health and Sport Sciences

Wroclaw, Lower Silesian Voivodeship, 51-612, Poland

Location

Jan Dlugosz University in Czestochowa

Częstochowa, Upper Silesia, 42-200, Poland

Location

University of Silesia in Katowice

Katowice, Upper Silesi, 40-007, Poland

Location

Related Publications (16)

  • Zessin U, Dickhauser O, Garbade S. The Relationship Between Self-Compassion and Well-Being: A Meta-Analysis. Appl Psychol Health Well Being. 2015 Nov;7(3):340-64. doi: 10.1111/aphw.12051. Epub 2015 Aug 26.

    PMID: 26311196BACKGROUND
  • Allen AB, Leary MR. Self-Compassion, Stress, and Coping. Soc Personal Psychol Compass. 2010 Feb 1;4(2):107-118. doi: 10.1111/j.1751-9004.2009.00246.x.

    PMID: 20686629BACKGROUND
  • Neece CL, Chan N, Klein K, Roberts L, Fenning RM. Mindfulness-Based Stress Reduction for Parents of Children with Developmental Delays: Understanding the Experiences of Latino Families. Mindfulness (N Y). 2019 Jun;10(6):1017-1030. doi: 10.1007/s12671-018-1011-3. Epub 2018 Sep 6.

    PMID: 31191735BACKGROUND
  • Bohadana G, Morrissey S, Paynter J. Self-compassion: A Novel Predictor of Stress and Quality of Life in Parents of Children with Autism Spectrum Disorder. J Autism Dev Disord. 2019 Oct;49(10):4039-4052. doi: 10.1007/s10803-019-04121-x.

    PMID: 31267283BACKGROUND
  • Bohadana G, Morrissey S, Paynter J. Self-Compassion in Mothers of Children with Autism Spectrum Disorder: A Qualitative Analysis. J Autism Dev Disord. 2021 Apr;51(4):1290-1303. doi: 10.1007/s10803-020-04612-2.

    PMID: 32656737BACKGROUND
  • Bogels SM, Lehtonen A, Restifo K. Mindful Parenting in Mental Health Care. Mindfulness (N Y). 2010 Jun;1(2):107-120. doi: 10.1007/s12671-010-0014-5. Epub 2010 May 25.

    PMID: 21125026BACKGROUND
  • Wang H, Wang Q, Hu X, Han ZR. Mindfulness and Stress Among Parents of Children with Autism Spectrum Disorder in China. J Autism Dev Disord. 2022 May;52(5):2035-2045. doi: 10.1007/s10803-021-05011-x. Epub 2021 May 29.

    PMID: 34050845BACKGROUND
  • Cousineau TM, Hobbs LM, Arthur KC. The Role of Compassion and Mindfulness in Building Parental Resilience When Caring for Children With Chronic Conditions: A Conceptual Model. Front Psychol. 2019 Aug 5;10:1602. doi: 10.3389/fpsyg.2019.01602. eCollection 2019.

    PMID: 31428005BACKGROUND
  • Duncan LG, Coatsworth JD, Greenberg MT. A model of mindful parenting: implications for parent-child relationships and prevention research. Clin Child Fam Psychol Rev. 2009 Sep;12(3):255-70. doi: 10.1007/s10567-009-0046-3.

    PMID: 19412664BACKGROUND
  • Ettman CK, Abdalla SM, Cohen GH, Sampson L, Vivier PM, Galea S. Prevalence of Depression Symptoms in US Adults Before and During the COVID-19 Pandemic. JAMA Netw Open. 2020 Sep 1;3(9):e2019686. doi: 10.1001/jamanetworkopen.2020.19686.

    PMID: 32876685BACKGROUND
  • Friis AM, Johnson MH, Cutfield RG, Consedine NS. Kindness Matters: A Randomized Controlled Trial of a Mindful Self-Compassion Intervention Improves Depression, Distress, and HbA1c Among Patients With Diabetes. Diabetes Care. 2016 Nov;39(11):1963-1971. doi: 10.2337/dc16-0416. Epub 2016 Jun 22.

    PMID: 27335319BACKGROUND
  • Homan KJ, Sirois FM. Self-compassion and physical health: Exploring the roles of perceived stress and health-promoting behaviors. Health Psychol Open. 2017 Sep 14;4(2):2055102917729542. doi: 10.1177/2055102917729542. eCollection 2017 Jul-Dec.

    PMID: 29379620BACKGROUND
  • Ten Hoopen LW, de Nijs PFA, Duvekot J, Greaves-Lord K, Hillegers MHJ, Brouwer WBF, Hakkaart-van Roijen L. Children with an Autism Spectrum Disorder and Their Caregivers: Capturing Health-Related and Care-Related Quality of Life. J Autism Dev Disord. 2020 Jan;50(1):263-277. doi: 10.1007/s10803-019-04249-w.

    PMID: 31625009BACKGROUND
  • Kuhlthau KA, Luberto CM, Traeger L, Millstein RA, Perez GK, Lindly OJ, Chad-Friedman E, Proszynski J, Park ER. A Virtual Resiliency Intervention for Parents of Children with Autism: A Randomized Pilot Trial. J Autism Dev Disord. 2020 Jul;50(7):2513-2526. doi: 10.1007/s10803-019-03976-4.

    PMID: 30900195BACKGROUND
  • Robinson S, Hastings RP, Weiss JA, Pagavathsing J, Lunsky Y. Self-compassion and psychological distress in parents of young people and adults with intellectual and developmental disabilities. J Appl Res Intellect Disabil. 2018 May;31(3):454-458. doi: 10.1111/jar.12423. Epub 2017 Nov 9.

    PMID: 29119672BACKGROUND
  • Turnage D, Conner N. Quality of life of parents of children with Autism Spectrum Disorder: An integrative literature review. J Spec Pediatr Nurs. 2022 Oct;27(4):e12391. doi: 10.1111/jspn.12391. Epub 2022 Aug 20.

    PMID: 35986656BACKGROUND

MeSH Terms

Conditions

Caregiver BurdenAutistic Disorder

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorAutism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Małgorzata Sekułowicz, Professor

    Wroclaw University of Health and Sport Sciences

    STUDY CHAIR
  • Krystyna Boroń-Krupińska, PhD

    Wroclaw University of Health and Sport Sciences

    PRINCIPAL INVESTIGATOR
  • Sylwia Wrona, PhD

    University of Silesia in Katowice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 17, 2022

Study Start

October 1, 2021

Primary Completion

January 30, 2023

Study Completion

February 28, 2023

Last Updated

March 20, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations