NCT06522243

Brief Summary

The goal of the study is to evaluate the effectiveness of an online eight-week mindful parenting program for parents of adolescents with special needs and its impact on parents' wellbeing and behaviors of their adolescents with SEN(s). Researchers will randomize the participants into the immediate intervention group (to start the intervention soon after recruitment) and the waitlist control group (to start the intervention after the immediate intervention group) so as to compare the changes between the two groups. The participants will join the 8-week mindful parenting intervention and one follow-up session. They will be asked to fill in the questionnaires at baseline, after the 8-week intervention, and at the follow-up sessions. Training sessions will be audio-taped and transcripted. The conversation during the zoom classes and participants' sharing on their subjective experience related to mindfulness practices will be analysed.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress57%
Aug 2024Aug 2027

First Submitted

Initial submission to the registry

July 15, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

August 9, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

2.1 years

First QC Date

July 15, 2024

Last Update Submit

June 24, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Parental Stress

    Parental Stress Scale is an 18-item self-report measure in which parents respond to statements about their typical relationship with their child. For each statement, respondents rate their level of agreement on a 5-point Likert scale (1- strongly disagree, 2 - disagree, 3- undecided, 4 - agree, and 5 -strongly agree).Higher scores reflect more parental stress. The possible range of the PSS is 18 (low stress) to 90 (high stress).

    16 weeks

  • Mindfulness in Parenting

    The 31-item Chinese version of the Interpersonal Mindfulness in Parenting Scale (IM-P) will be used to evaluate parents' mindfulness on four aspects, including compassion for the child, nonjudgmental acceptance in parenting, emotional awareness, and listening with full attention. A total sum will be calculated to indicate mindfulness in parenting with a higher score implying better outcome (minimum value=31; maximum value=155).

    16 weeks

  • Parents' Expressed Emotion

    Family Questionnaire (FQ) is used to evaluate the parents' level of expressed emotion, including criticism and over-involvement. FQ is a 20-item parent self-rated questionnaire with four possible answers ranging from "never/very rarely" to "very often." A total score will be calculated with a higher score indicating a a higher level of expressed emotion (minimum value=20; maximum value=80).

    16 weeks

  • Children's behaviors

    The 25-item Chinese version of the Strength and Difficulties Questionnaire (SDQ) will be used to assess the externalising and internalising problems of adolescents. It comprises five subscales, ranging from emotional problems, conduct problems, hyperactivity, peer problems and prosocial behaviours in adolescents. Each item is rated on a Likert scale from 0 (not true) to 2 (certainly true). A total difficulties score will be calculated with a higher score implying more difficult behaviors by summing scores from all the items except the prosocial scale (minimum value=0; maximum value=40).

    16 weeks

Secondary Outcomes (3)

  • General Mindfulness Awareness

    16 weeks

  • Decentering

    16 weeks

  • Parenting Skills

    16 weeks

Other Outcomes (1)

  • Subjective experiences with mindful parenting

    16 weeks

Study Arms (2)

immediate intervention

EXPERIMENTAL

Start with the 8-week intervention immediately/soon after recruitment

Behavioral: 8-week mindful parenting program

waitlist control

NO INTERVENTION

No intervention while being assessed but will receive the intervention after the assessments

Interventions

The current study adopts the Mindful Parenting program developed by Prof Susan Bögels (Bögels \& Restifo, 2013), which is an application of mindfulness-based intervention which aims to improve parenting by reducing parents' own stress levels, decreasing parental automatic reactivity, increasing open and unbiased attitudes towards children, and decreasing inter-generational dysfunctional parenting (Bögels et al., 2014). The program consists of eight consecutive weeks of parent groups and one follow-up session two months after the last session. Each parent group will include 15-20 participants. The original Mindful Parenting Program will last for around 3 hours for each session, with the longest practice of 40 minutes. Considering parents recruited in the study may have a higher risk of psychiatric conditions than the general population, each session of mindful parenting group will be reduced to 2 to 2.5 hours with the longest mindfulness practice of 30 minutes (Baer et al., 2019).

immediate intervention

Eligibility Criteria

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

You may qualify if:

  • with one adolescent child with special educational need(s)
  • being the major caregiver for the adolescent for at least one year
  • Cantonese speaker

You may not qualify if:

  • schizophrenia-spectrum disorder
  • bipolar disorder
  • substance abuse
  • developmental disabilities
  • physical disabilities
  • with active psychotic symptoms
  • high suicidal risks
  • experiencing a recent personal crisis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xu Jia-QI

Hong Kong, Hong Kong

RECRUITING

Related Publications (8)

  • Kogure H. [Brain metabolism disorder associated with cerebral ischemia]. Nihon Rinsho. 1985 Feb;43(2):349-60. No abstract available. Japanese.

    PMID: 2987569BACKGROUND
  • Shiba R, Sakoda S, Yamada N. Peripheral ameloblastoma. J Oral Maxillofac Surg. 1983 Jul;41(7):460-3. doi: 10.1016/0278-2391(83)90132-5.

    PMID: 6575147BACKGROUND
  • Butzlaff RL, Hooley JM. Expressed emotion and psychiatric relapse: a meta-analysis. Arch Gen Psychiatry. 1998 Jun;55(6):547-52. doi: 10.1001/archpsyc.55.6.547.

    PMID: 9633674BACKGROUND
  • Crijnen AA, Achenbach TM, Verhulst FC. Problems reported by parents of children in multiple cultures: the Child Behavior Checklist syndrome constructs. Am J Psychiatry. 1999 Apr;156(4):569-74. doi: 10.1176/ajp.156.4.569.

    PMID: 10200736BACKGROUND
  • Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

    PMID: 7726811BACKGROUND
  • van der Oord S, Bogels SM, Peijnenburg D. The Effectiveness of Mindfulness Training for Children with ADHD and Mindful Parenting for their Parents. J Child Fam Stud. 2012 Feb;21(1):139-147. doi: 10.1007/s10826-011-9457-0. Epub 2011 Feb 2.

    PMID: 22347788BACKGROUND
  • Wiedemann G, Rayki O, Feinstein E, Hahlweg K. The Family Questionnaire: development and validation of a new self-report scale for assessing expressed emotion. Psychiatry Res. 2002 Apr 15;109(3):265-79. doi: 10.1016/s0165-1781(02)00023-9.

    PMID: 11959363BACKGROUND
  • Xu JQ, Poon K, Ho MSH. Brief Report: The Impact of COVID-19 on Parental Stress and Learning Challenges for Chinese Children with SpLD. J Autism Dev Disord. 2025 Jun;55(6):2186-2193. doi: 10.1007/s10803-023-05983-y. Epub 2023 Apr 20.

    PMID: 37079179BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Central Study Contacts

Jiaqi Xu, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: waitlist randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Professional Practitioner

Study Record Dates

First Submitted

July 15, 2024

First Posted

July 26, 2024

Study Start

August 9, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2027

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations