NCT05833269

Brief Summary

The goal of this clinical trial is to test the effectiveness of an adapted mindfulness and compassion-based intervention (IBAP) in reducing parental burnout in Chilean mothers who telework while living with children under 18 years old. The main questions it aims to answer are:

  • Can the intervention reduce symptoms of parental burnout in the short term (3 months) and medium-term (6 and 9 months) compared to the control group?
  • Can the intervention improve work engagement in the intervention group compared to the control group? Participants will be randomly assigned to either the intervention group or the active control group. The intervention group will receive the IBAP program while the active control group will receive a relaxation audio guide. Both group will receive parental burnout educational material, invitation to a Whatsapp group and a weekly email reminders. Parental Burnout (PBA) will be measured at baseline, 3, 6, and 9 months, and work engagement will be measured at the same time points. Researchers will compare the intervention group to the active control group to see if the IBM program is more effective in reducing parental burnout and improving work engagement,

Trial Health

55
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

March 13, 2025

Status Verified

September 1, 2024

Enrollment Period

1.4 years

First QC Date

April 6, 2023

Last Update Submit

March 10, 2025

Conditions

Keywords

Parental BurnoutBurnoutMindfulnessCompassionIntercare

Outcome Measures

Primary Outcomes (1)

  • Parental Burnout Assessment

    The Parental Burnout Assessment (PBA) is a questionnaire validated in Chile that consists of 23 items and evaluates the four main symptoms of parental burnout: emotional exhaustion (9 items), contrast with the parent's previous self (6 items; e.g., I tell myself that I am no longer the parent I used to be), loss of pleasure in the parenting role (5 items; e.g., I don't enjoy spending time with my children), and emotional distancing from children (3 items; e.g., I can no longer show my children that I love them). A 7-point frequency scale is used, with higher scores indicating higher levels of parental burnout. The score is calculated by adding up the scores of the items, with a maximum score of 138 points (Roskam et al., 2021).

    9 months

Secondary Outcomes (71)

  • Parental Burnout Assessment

    3 months

  • Parental Burnout Assessment

    12 months

  • Parental Burnout Assessment

    18 months

  • Parental Burnout Assessment

    24 months

  • Five Facets of Mindfulness Questionnaire - 15 items

    3 months

  • +66 more secondary outcomes

Study Arms (3)

Mindfulness and compassion based intercare program

EXPERIMENTAL

This 8-week intervention aims to reduce parental burnout by adapting the "Mindfulness-based Inter-care Program" and incorporating elements from MBSR, MBCT, and CBCT. The program includes 8 modules with practical and theoretical activities, weekly tasks, journaling, and daily meditation practices such as body exploration, seated and moving meditation, walking and eating meditation, acceptance, compassion, and gratitude. The program also promotes values such as time management, attentive parenting, and emotional management while addressing factors of risk for parental burnout such as perfectionism, low emotional intelligence, lack of parenting practices, excessive responsibilities, and lack of support. Participants will receive two weekly reminders via email to perform the practices and review information. Additionally, they will have the option to participate in a virtual group via the WhatsApp platform with other participants.

Behavioral: Mindfulness and Compassion based Intercare program for parental burnout reduction (IBAP-BP)Behavioral: Educational materialBehavioral: Reminder by emailBehavioral: Whatsapp support groupBehavioral: Journaling

Audio guide relaxation control group

ACTIVE COMPARATOR

The active control group in this study will be provided with a 20-minute relaxation audio containing Jacobson's progressive relaxation instructions. This intervention aims to control for attention and time while allowing for comparison to the experimental group. Also, journaling was included. Additionally, the program will include information on risk factors for parental burnout, such as parental perfectionism, low emotional intelligence, lack of parenting practices, excessive responsibilities, and lack of support. Two weekly email reminders will be sent to encourage daily practice and review of the information provided. Participants will also have the option to participate in a virtual support group through the WhatsApp platform with other participants. This active control group intervention aims to improve participant well-being by providing relaxation techniques and support for the challenges of parenting.

Behavioral: Educational materialBehavioral: Reminder by emailBehavioral: Whatsapp support groupBehavioral: JournalingBehavioral: Guided relaxation excercise

Waiting List Group

NO INTERVENTION

The waiting list group will receive the intervention after the primary outcome is measured. No intervention was provided before this point.

Interventions

The interventions is an adaptation of an 8-week program called Mindfulness and Compassion based Intercare program designed to reduce burnout. The adaptation includes a parental burnout risk and resource balance framework, focusing on factors such as parental perfectionism, low emotional intelligence, lack of parenting practices, excess parental responsibilities, lack of co-parental support, and lack of social support. The program consists of 8 modules with practical and theoretical activities and daily tasks that require 10-30 minutes. The modules cover topics such as mindfulness, coping with stress, empathy, and self-care. Formal meditation practices include body exploration, sitting, movement, walking, eating, acceptance, compassion, and gratitude. The program also includes descriptions and motivation for practices related to identifying values that promote parenting, time management, attentive parenting techniques, and emotional management.

Also known as: Intercuidado basado en atencion plena
Mindfulness and compassion based intercare program

On a weekly basis, participants will receive reminder emails highlighting specific risk factors associated with parental burnout. These risk factors include parental perfectionism, low emotional intelligence, lack of parenting practices, excessive responsibilities, and lack of support. Each week, the reminder email will cover a different topic, providing participants with relevant information.

Audio guide relaxation control groupMindfulness and compassion based intercare program

Every week, participants will receive two reminder emails: one with a list of activities to complete during the week and another containing information about parental burnout. This approach aims to support participants in staying engaged with the program.

Audio guide relaxation control groupMindfulness and compassion based intercare program

The participants will have the option to join a WhatsApp group with 25 other members from the specific group to receive daily greetings, group support, and have general doubts resolved.

Audio guide relaxation control groupMindfulness and compassion based intercare program
JournalingBEHAVIORAL

As part of the mindfulness intervention, participants are required to write in a journal every day with the purpose of cultivating awareness of bodily sensations, emotions, thoughts, and impulses. Each week, the journaling topic focuses on a different area, including pleasant experiences, unpleasant experiences, needs and resources, communication difficulties, and sharing resources. In contrast, the control group's journaling activity involves free writing about everyday issues, thoughts, and ideas.

Audio guide relaxation control groupMindfulness and compassion based intercare program

Participants receive a 10 and 20-minute relaxation exercise guide called the Jacobson Progressive Relaxation, which they are expected to practice daily.

Audio guide relaxation control group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mother living with at leat one child over the same roof
  • Telework at leat one day per week
  • Work at leat three days per week

You may not qualify if:

  • Self reported acute severe depression
  • Self reported psychotic disorder
  • Self reported substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Diego Portales

Santiago, Santiago Metropolitan, 7850345, Chile

Location

MeSH Terms

Conditions

Caregiver BurdenBurnout, Psychological

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Francisco Javier VILLALON LOPEZ

    Diego Portales University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 6, 2023

First Posted

April 27, 2023

Study Start

December 22, 2022

Primary Completion

April 30, 2024

Study Completion

January 31, 2026

Last Updated

March 13, 2025

Record last verified: 2024-09

Locations