Breath-focused mindfulness and compassion training for parent-child dyads
| ISRCTN | ISRCTN89594822 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89594822 |
| Secondary identifying numbers | National Institutes of Health subaward grant: NIH/NCCIH 5U24AT011289 |
- Submission date
- 07/10/2024
- Registration date
- 09/10/2024
- Last edited
- 09/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Depression in children is a huge mental health concern and can further impact parental stress and well-being. A parent-child co-training digital application was developed in this study for practicing breath-focused mindfulness and compassion together. This study tests the hypothesis that the parent-child digital co-training of breath-focused mindfulness and compassion together will improve mental health symptoms, and cognition and facilitate neuroplasticity.
Who can participate?
Parent-child dyads where the child has Child Depression Index (CDI) scores in the average or above-average range (T-score>40)
What does the study involve?
The parent-child dyads receive the digital app intervention for about 3 months with pre and post-intervention assessments of mental health, cognition and electroencephalography (EEG)-derived brain function. Families also complete a 3-month follow-up of mental health assessments.
What are the possible benefits and risks of participating?
Benefits to participants may include improvements in well-being and/or cognition. This is a minimal-risk study.
Where is the study run from?
The University of California San Diego School of Medicine (USA)
When is the study starting and how long is it expected to run for?
February 2021 to August 2023
Who is funding the study?
1. Sanford Institute for Empathy and Compassion at the University of California San Diego
2. National Institutes of Health
Who is the main contact?
Jyoti Mishra, jymishra@ucsd.edu (USA)
Contact information
Public, Scientific, Principal Investigator
T. Denny Sanford Institute for Empathy and Compassion, 9500 Gilman Drive
La Jolla
92037
United States of America
 ORCID ID |
0000-0001-6612-4557 |
|---|---|
| Phone | +1 8582322855 |
| jymishra@ucsd.edu |
Study information
| Study design | Interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community, Home, Internet/virtual |
| Study type | Prevention, Quality of life |
| Participant information sheet | 46189_PIS.pdf |
| Scientific title | Breath-focused mindfulness and compassion training in parent-child dyads: a pilot intervention study |
| Study acronym | CoCo |
| Study hypothesis | The parent-child digital co-training of breath-focused mindfulness and compassion together will improve mental health symptoms, and cognition and facilitate neuroplasticity |
| Ethics approval(s) |
Approved 01/02/2021, Institutional Review Board of the University of California San Diego (9500 Gilman Dr, La Jolla, 92093, United States of America; +1 858-246-4777; hrpp@ucsd.edu), ref: Protocol #180140 |
| Condition | Depression |
| Intervention | The digital Cooperative Compassion (CoCo) training for parent-child dyads was delivered on the HIPAA-compliant BrainE© app with a de-identified and password-protected login provided to each family. Participants accessed the iOS/Android compatible smartphone app in their own free time and engaged in ~10 minutes of training per session for up to 30 sessions. The training was delivered in a game-like format and was performance-adaptive. Specifically, to practice breath-focused mindfulness, individuals were requested to close their eyes, pay attention to their breathing, and tap the mobile screen after a specific number of breaths from 1 breath up to 10 breaths at a time. Consistency of performance was monitored as users tapped the mobile screen after the instructed number of breaths while keeping their eyes closed; the screen was digitally split to simultaneously track both parent and child performance, i.e., one-half of the screen kept track of child finger traps while the other half kept track of parent taps. If both parent and child consistently monitored breathing for at least two-thirds of the duration at any given level, where level refers to the number of breaths monitored, then they would together progress to monitoring the next level/count of breaths. At every sixth session of training, compassion instructions were relayed by text and audio before the start of the breath-focused exercises so that users could discuss and keep these instructions in mind during their practice. Over 30 sessions, there were a total 5 levels of standard compassion training instructions provided focusing on (1) settling the mind, (2) compassion for a loved one, (3) compassion for self, (4) loving-kindness for self and (5) embracing common humanity; these instructions followed guidance from the Compassion Cultivation Training program. Finally, a distinct, calming nature scene is unveiled at the end of each session as a form of training reward. Parents received app notifications once a day reminding them to complete their training. |
| Intervention type | Behavioural |
| Primary outcome measure | The following primary outcome measures were assessed using self-report scales at baseline (pre), post-intervention completion and 3 month follow-up: For parents: 1. Stress was measured using the Depression Anxiety Stress Scale-21 (DASS-21) 2. General anxiety was measured using the General Anxiety Disorder-7 (GAD-7) 3. Depression measured using the Patient Health Questionnaire (PHQ-9) 4. Mindfulness was measured using the 14-item Mindful Attention Awareness Scale (MAAS) For children: 1. Child depression was measured using the Children Depression Index by child (CDI-Child): 12-item self-report by child 2. Child depression was measured using the Children Depression Index by parent (CDI-Parent): 17-item report by parent |
| Secondary outcome measures | 1. Emotional bias measured using a cognitive assessment at pre- and post-intervention 2. Interoceptive attention to breathing measured using an objective neurophysiological assessment at pre- and post-intervention |
| Overall study start date | 01/02/2021 |
| Overall study end date | 13/08/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 5 Years |
| Upper age limit | 54 Years |
| Sex | Both |
| Target number of participants | 48 |
| Total final enrolment | 48 |
| Participant inclusion criteria | 1. Children assessed in teh average and above-average range (T-score>40) on the Child Depression Index (CDI) 2. Parents were healthy and did not report any current diagnoses or medications |
| Participant exclusion criteria | 1. Self-reported severe illness for a parent or child that would not allow time for study participation |
| Recruitment start date | 19/07/2021 |
| Recruitment end date | 17/03/2023 |
Locations
Countries of recruitment
- United States of America
Study participating centre
San Diego
92037
United States of America
Sponsor information
University/education
T. Denny Sanford Institute for Empathy and Compassion, 9500 Gilman Drive
La Jolla
92093
United States of America
| Phone | +1 (858) 534-2230 |
|---|---|
| empathyandcompassion@health.ucsd.edu | |
| Website | https://empathyandcompassion.ucsd.edu/ |
"ROR" |
https://ror.org/0168r3w48 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- UC San Diego, University of California San Diego, UCSD
- Location
- United States of America
No information available
Results and Publications
| Intention to publish date | 12/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository, https://datadryad.org/. The type of data stored includes all data outcome variables collected and analysed for the study. The data will be freely available for download post-publication of the research. Consent was obtained from participants for de-identified data sharing. The data will be de-identified and do not have any personal health information for participants. The data are de-identified with no ethical or legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 09/10/2024 | No | Yes |
Additional files
Editorial Notes
08/10/2024: Study's existence confirmed by the sanford institute for empathy and compassion.
