Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000375752
Ethics application status
Approved
Date submitted
11/01/2022
Date registered
3/03/2022
Date last updated
3/03/2022
Date data sharing statement initially provided
3/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of a Mindful Parenting Intervention
Scientific title
Effectiveness of In-Person and Online Mindful Parenting Interventions for Parents of Children with Anxiety Disorders
Secondary ID [1] 306170 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety Disorders 324879 0
Condition category
Condition code
Mental Health 322315 322315 0 0
Anxiety
Mental Health 322316 322316 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parents participated in an 8-session mindfulness-based parenting intervention (MPI) and attended group sessions in-person at the Griffith University Psychology Clinic or online via videoconferencing (Zoom). The MPI was adapted from the manualised mindful parenting program (Bögels & Restifo, 2014) which is traditionally delivered in-person across eight weekly 3.5-hour group- sessions, including home-practice and a booster session. Adaptations included shortened session duration to aid parental engagement in the two formats. The in-person MPI consisted of eight weekly 2.5-hour long sessions, while the online MPI delivered eight 1.5-hour long sessions over 5 weeks. A 1.5-hour long booster session was offered 2 (online) or 3 months (in-person) after the end of the intervention. Overall, the in-person MPI duration was 40 hours, the online MPI duration was 32 hours.

Session Content (as per Bögels & Restifo, 2014):
Session 1: Automatic pilot parenting versus non-reactive parenting, doing versus being mode. Session and Home-Practice Exercises: Body scan, Child as a raisin, Mindful routine activity, Nurturing activity, Mindful first bite or sip.
Session 2: Beginner’s mind parenting, expectations and interpretations, attitude of kindness. Session and Home-Practice Exercises: Body scan, Sitting meditation: Breath awareness, Mindful routine activity, Mindful routine activity with child, Savouring pleasant moments.
Session 3: Reconnecting with the body as a parent during stressful parenting situations, recognising own limits, self-compassion when stress. Session and Home-Practice Exercises: Yoga (lying), Sitting meditation: breath + body, 3-min breathing space, Mindful activity with your child, Stressful moments log, Self-compassion break.
Session 4: Responding versus reacting to parenting stress through awareness and acceptance. Session and Home-Practice Exercises: Yoga (standing), Sitting meditation: breath, body, sounds + thoughts, 3-min breathing space under stress, parenting stress calendar, Autobiography.
Session 5: Parenting patterns and schemas, recognising patterns from own childhood, being with strong emotions, and recognising activated schema modes (angry and vulnerable child, punitive and demanding parent, versus healthy parent mode). Session and Home-Practice Exercises: Sitting meditation: breath, body, sounds, thoughts, + emotions, Walking meditation, 3-min breathing when child is misbehaving, Parental stress + schema mode recognition calendar.
Silent Retreat: Deepening of mindfulness practices through guided meditation, yoga, eating and walking exercises in silence. (Attendance optional.) Home-Practice Exercises: Self-guided silent mindfulness day at home where attendance in-person not possible.
Session 6: Conflict and parenting, perspective taking, rupture and repair, tuning into child’s emotional states. Session and Home-Practice Exercises: Own 40 min practice choice, Rupture and repair practice, 3-min breathing space when stressed.
Session 7: Love, self-compassion and setting limits for self, child, and others. Home-Practice Exercises: Own 40 min practice choice, Write narrative, Mindful limit setting, Sitting meditation: Loving-kindness, Identify and bring in symbolic object.
Session 8: Review and setting intentions for continued mindful parenting practice in the future. Home-Practice Exercises: Own practice choice.
Booster session: Experiences and obstacles over past 2-3 months, and renewed intentions for practicing mindful parenting. (Attendance optional.) Home-Practice Exercises: Own practice choice

Mode of delivery:
All 8 sessions are delivered in groups (either in-person at the Psychology Clinic, or online via Zoom); involve group discussion and enquiries after experiential exercises, interactive activities (i.e., experiential exercises; mindfulness and mindful parenting practices), a short video on attention blindness, demonstrations and role-plays by/with the group facilitators.

The online sessions were reduced from 2.5 hours to 1.5 hours. Otherwise, the session content remained the same. We did this by shortening several formal meditation practices, including body scans, sitting meditations, and yoga practices. We used Powerpoint slides to show session content on screen during sessions when relevant, and the Zoom “share screen” function as a whiteboard for parent input during group exercises, and the “breakout rooms” function for parents to work in small groups or pairs. For body scans, standing/walking meditation, and yoga some parents chose to turn off their camera during the practice. Apart from these changes, the online sessions were run as similarly as possible to the in-person sessions and the content remained the same as per the manualised program, including the presence of facilitators at all times. Parents were encouraged to act as if they were together in the same room with the facilitators and other group members. Parents were asked to find a private space for the sessions, where they could participate in meditation exercises and group discussions free from interruptions from other family members.

Parents were asked to complete between 4 to 6 daily home-practices (approx. 1 hour per day) between sessions, including a facilitator-guided silent retreat or a self-guided mindfulness day at home. Parents received a workbook with information (adapted from a readily available source: information and handouts derived from the manualised program in Bögels & Restifo, 2014), worksheets and home-practice record logs, and a custom-made phone application (Kids in Mind app) with audio-recordings of practices. Sessions were audio (in-person) and/or video (online) recorded. Parents who missed a session were contacted by the facilitators via telephone and/or email to review key content and home-practices. Additionally, online participants received access to session recordings.

Facilitators were instructed by one of the program developers (Susan Bögels), and completed a whole day (8 hours) MPP training workshop with her as well as several 1 to 2-hour supervision sessions during a week-long stay of Susan at the Gold Coast, Griffith University in December 2018 prior to recruitment of the first participants. Sessions were delivered by a lead-facilitator (clinical psychologist) who was a trained mindfulness teacher, supported by a co-facilitator (doctoral-level psychologist in clinical training); both had established mindfulness and yoga practice over 10 to 15 years. Session recordings and intervention progress were reviewed in supervision with a clinical psychologist who was a trained and experienced mindfulness teacher and MPI facilitator.
Intervention code [1] 322578 0
Treatment: Other
Comparator / control treatment
No control group. Baseline controlled open trial study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330079 0
Parenting Stress: Parenting Stress Index-Short Form
(PSI-SF)
Timepoint [1] 330079 0
Baseline (2 to 8 weeks before the intervention commencement), pre-intervention (immediately before commencement of first session), post-intervention (in the week following the last session, primary time-point), follow-up (in the week following the booster session).
Primary outcome [2] 330080 0
Child Diagnostic Status (Clinician rated): Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)
Timepoint [2] 330080 0
Baseline (2 to 8 weeks before the intervention commencement), post-intervention (in the week following the last session, primary time-point)
Primary outcome [3] 330081 0
Child Anxiety Severity (parent rated): Pre-schooler’s Anxiety Scale- Parent (PAS-P; for 3-5 year olds); Spence Children’s Anxiety Scale for Parents (SCASP; for 6-7 year olds)
Timepoint [3] 330081 0
Baseline (2 to 8 weeks before the intervention commencement), pre-intervention (immediately before commencement of first session), post-intervention (in the week following the last session, primary time-point), follow-up (in the week following the booster session).
Secondary outcome [1] 404813 0
Parental Psychopathology Symptoms: Brief Symptom Inventory (BSI)
Timepoint [1] 404813 0
Baseline (2 to 8 weeks before the intervention commencement), pre-intervention (immediately before commencement of first session), post-intervention (in the week following the last session), follow-up (in the week following the booster session).
Secondary outcome [2] 404814 0
Parental Burden: Family Burden Assessment Scale (BAS)
Timepoint [2] 404814 0
Baseline (2 to 8 weeks before the intervention commencement), post-intervention (in the week following the last session), follow-up (in the week following the booster session).
Secondary outcome [3] 404815 0
Parental Rearing Behaviours: Egna Minnen Beraffande Uppfostran: My Memories from my Upbringing
(EBMU)
Timepoint [3] 404815 0
Baseline (2 to 8 weeks before the intervention commencement), post-intervention (in the week following the last session), follow-up (in the week following the booster session).
Secondary outcome [4] 404816 0
Dispositional Mindfulness: Five Facet Mindfulness Questionnaire (FFMQ)
Timepoint [4] 404816 0
Baseline (2 to 8 weeks before the intervention commencement), post-intervention (in the week following the last session), follow-up (in the week following the booster session).
Secondary outcome [5] 404817 0
Mindfulness in Parenting: Interpersonal Mindfulness in Parenting (I-MP)
Timepoint [5] 404817 0
Baseline (2 to 8 weeks before the intervention commencement), post-intervention (in the week following the last session), follow-up (in the week following the booster session).
Secondary outcome [6] 404818 0
Emotion Regulation Problems: Difficulties in Emotion Regulation Scale (DERS)
Timepoint [6] 404818 0
Baseline (2 to 8 weeks before the intervention commencement), post-intervention (in the week following the last session), follow-up (in the week following the booster session).
Secondary outcome [7] 404819 0
Parental Experiential Avoidance in Parenting: Parental Acceptance and Action Questionnaire (PAAQ)
Timepoint [7] 404819 0
Baseline (2 to 8 weeks before the intervention commencement), post-intervention (in the week following the last session), follow-up (in the week following the booster session).
Secondary outcome [8] 404820 0
Self-Compassion: Neff’s Self-Compassion Scale (SCS)
Timepoint [8] 404820 0
Baseline (2 to 8 weeks before the intervention commencement), post-intervention (in the week following the last session), follow-up (in the week following the booster session).
Secondary outcome [9] 404821 0
Child Externalising Symptoms: Child Behaviour Checklist Preschool 1.5-5 (CBCL 1.5-5 Externalising sub-scales)
Timepoint [9] 404821 0
Baseline (2 to 8 weeks before the intervention commencement), post-intervention (in the week following the last session), follow-up (in the week following the booster session).
Secondary outcome [10] 404822 0
Child Anxiety Interference: Child Anxiety Life Interference Scale and Preschool Version (CALIS & CALIS-P) administered based on child age
Timepoint [10] 404822 0
Baseline (2 to 8 weeks before the intervention commencement), post-intervention (in the week following the last session), follow-up (in the week following the booster session).
Secondary outcome [11] 404823 0
Executive Functions (Parent; Disrupted due to the pandemic): CANTAB computerised tasks: Stop Signal Task (SST); Intra-Extra Dimensional Set Shift (IED); Spatial Span (SSP)
Timepoint [11] 404823 0
Baseline (2 to 8 weeks before the intervention commencement), post-intervention (in the week following the last session)
Secondary outcome [12] 404824 0
Objective rearing behaviours (Disrupted due to the pandemic): Observed parent-child interactions and parenting behaviours during behavioural observations of a child speech preparation task, and tangram puzzles tasks. Using the observation coding manual from Jennifer L Hudson, Ronald M. Rapee,
Donna Jacobs & Marije Vrieze
Timepoint [12] 404824 0
Baseline (2 to 8 weeks before the intervention commencement), post-intervention (in the week following the last session)
Secondary outcome [13] 404825 0
Treatment Satisfaction: Modified Group Session Rating Scale (GSR)
Timepoint [13] 404825 0
During each intervention session
Secondary outcome [14] 404826 0
Program satisfaction: Client Satisfaction Questionnaire (CSQ-8)
Timepoint [14] 404826 0
Post-intervention (in the week following the last session)
Secondary outcome [15] 404827 0
Home-practice Compliance: Assessed by investigators via Home-practice worksheets that are completed by parents over the days in between sessions to record each time they practiced home tasks.
Timepoint [15] 404827 0
During each intervention session
Secondary outcome [16] 404828 0
Intervention Attendance: Session attendance checklist (completed by the Clinician)
Timepoint [16] 404828 0
At each intervention Session
Secondary outcome [17] 405871 0
Child Diagnostic Severity (Clinician rated): Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)
assessed as part of the primary outcome "Diagnostic Status"
Timepoint [17] 405871 0
Baseline (2 to 8 weeks before the intervention commencement;), post-intervention (in the week following the last session)

Eligibility
Key inclusion criteria
- Parents of children aged 3-7 years
- Parent and/or child understand and speak the English language
- At least one parent available to complete all assessments and attend all MPI sessions
- Children meet a DSM anxiety disorder diagnosis (Separation Anxiety Disorder, Social Phobia, Generalised Anxiety, or Specific Phobia) according to the ADIS-IV
- Child’s IQ estimate within normal range (as indexed by no diagnosed developmental or learning disorder, or significant learning or language delays).
- Parent and/or child are willing to cease any other concurrent psychotherapy
- If on medication, parent and/or child required to be on a stable dose for at least 12 weeks prior to randomisation and no medication changes during the intervention duration
Minimum age
3 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Parent’s DSM-V diagnoses of Bipolar disorder, psychotic disorders and/or active psychotic symptoms, depersonalisation disorder, derealisation disorder; and/or presence of suicidal ideation
- Parent’s presence of substance use disorder/problems
Parent’s DSM-5 diagnoses of internalising disorders (e.g., anxiety disorders, mood disorders) in upper moderate to severe range
- No psychiatric hospitalisation within the past 6 months of parent or child
- Current child-safety clients or parents identified as violent/neglectful
- Parent or child with serious medical condition making attendance at the clinic difficult
- Child presence of suicidality

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
During 2019/early 2020 (pre-COVID-19 pandemic), participants completed the intervention and assessments in-person.
During 2020 (during COVID-19 pandemic), participants completed the intervention and assessments online.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The Sample size has been estimated using power analysis. Feasibility, effectiveness across time, predictors/mediators/moderators will be evaluated using a number of parametric and non-parametric statistical analyses in SPSS and via calculation of reliable change indices.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/06/2019
Date of last participant enrolment
Anticipated
Actual
5/08/2020
Date of last data collection
Anticipated
Actual
25/11/2020
Sample size
Target
70
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 36348 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 310515 0
University
Name [1] 310515 0
Griffith University
Country [1] 310515 0
Australia
Primary sponsor type
Individual
Name
Prof Lara Farrell
Address
School of Applied Psychology, Griffith University
Parklands Dr, Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 311681 0
Individual
Name [1] 311681 0
Ms Robyn Farley
Address [1] 311681 0
School of Applied Psychology, Griffith University
Parklands Dr, Southport QLD 4215
Country [1] 311681 0
Australia
Secondary sponsor category [2] 311684 0
Individual
Name [2] 311684 0
Ms Natalja Nabinger de Diaz
Address [2] 311684 0
School of Applied Psychology, Griffith University
Parklands Dr, Southport QLD 4215
Country [2] 311684 0
Australia
Secondary sponsor category [3] 311685 0
Individual
Name [3] 311685 0
Dr Lisa-Marie Emerson
Address [3] 311685 0
University of Canterbury, Kirkwood Avenue, Upper Riccarton, Christchurch 8041, New Zealand
Country [3] 311685 0
New Zealand
Secondary sponsor category [4] 311686 0
Individual
Name [4] 311686 0
Prof Caroline Donovan
Address [4] 311686 0
School of Applied Psychology, Griffith University, Mt Gravatt Campus
176 Messines Ridge Rd, Mount Gravatt QLD 4122
Country [4] 311686 0
Australia
Secondary sponsor category [5] 311687 0
Individual
Name [5] 311687 0
Prof Allison Waters
Address [5] 311687 0
School of Applied Psychology, Griffith University, Mt Gravatt Campus
176 Messines Ridge Rd, Mount Gravatt QLD 4122
Country [5] 311687 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310140 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 310140 0
Ethics committee country [1] 310140 0
Australia
Date submitted for ethics approval [1] 310140 0
25/10/2018
Approval date [1] 310140 0
06/11/2018
Ethics approval number [1] 310140 0
GU Ref No: 2018/894

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116618 0
Prof Lara Farrell
Address 116618 0
School of Applied Psychology, Griffith University
Parklands Dr, Southport QLD 4215
Country 116618 0
Australia
Phone 116618 0
+61 07 5678 8224
Fax 116618 0
Email 116618 0
[email protected]
Contact person for public queries
Name 116619 0
Natalja Nabinger de Diaz
Address 116619 0
School of Applied Psychology, Griffith University
Parklands Dr, Southport QLD 4215
Country 116619 0
Australia
Phone 116619 0
+61 07 5678 8317
Fax 116619 0
Email 116619 0
[email protected]
Contact person for scientific queries
Name 116620 0
Natalja Nabinger de Diaz
Address 116620 0
School of Applied Psychology, Griffith University
Parklands Dr, Southport QLD 4215
Country 116620 0
Australia
Phone 116620 0
+61 07 5678 8317
Fax 116620 0
Email 116620 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Undecided at this stage.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.