NCT04999514

Brief Summary

This study investigates the effects of parenting interventions on improving the emotion regulation and functioning of the children with AD/HD as well as their parents' parenting practices and psychological well-being. Two kinds of parenting interventions are selected in this study, namely the Mindful Parenting and Tuning in to Kids programs. The value of this project lies in empowering parents through parenting techniques which they can use both for themselves and for their daily interactions with children. It is hoped to alleviate their stress from the role of parenting children with special needs, which may in turn lead to their better psychological well-being and greater harmony in the families.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 5, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

November 3, 2022

Status Verified

July 1, 2021

Enrollment Period

10 months

First QC Date

July 5, 2021

Last Update Submit

November 1, 2022

Conditions

Keywords

Mindful parentingEmotion coachingParenting practiceParenting stress

Outcome Measures

Primary Outcomes (18)

  • Mindful parenting practice

    Interpersonal Mindfulness in Parenting (IM-P) \[Min. Value: 1; Max Value: 5 (with higher score indicating higher level of mindful parenting)\]

    Pre-intervention (within 4 weeks before the commencement of parenting program)

  • Mindful parenting practice

    Interpersonal Mindfulness in Parenting (IM-P) \[Min. Value: 1; Max Value: 5 (with higher score indicating higher level of mindful parenting)\]

    Immediate Post-intervention (within 4 weeks after the completion of parenting program)

  • Mindful parenting practice

    Interpersonal Mindfulness in Parenting (IM-P) \[Min. Value: 1; Max Value: 5 (with higher score indicating higher level of mindful parenting)\]

    Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)

  • Emotion coaching practice

    Parent Emotional Style Questionnaire (PESQ) \[Min. Value: 1; Max Value: 5 (with higher score indicating higher frequency of the parent emotional style in a particular subscale)\]

    Pre-intervention (within 4 weeks before the commencement of parenting program)

  • Emotion coaching practice

    Parent Emotional Style Questionnaire (PESQ) \[Min. Value: 1; Max Value: 5 (with higher score indicating higher frequency of the parent emotional style in a particular subscale)\]

    Immediate Post-intervention (within 4 weeks after the completion of parenting program)

  • Emotion coaching practice

    Parent Emotional Style Questionnaire (PESQ) \[Min. Value: 1; Max Value: 5 (with higher score indicating higher frequency of the parent emotional style in a particular subscale)\]

    Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)

  • Parents' psychological well-being

    Depression Anxiety Stress Scale 21 (DASS 21) \[Min. Value: 0; Max Value: 3 (with higher score indicating more symptoms of depression, anxiety or stress in the respective subscale)\]

    Pre-intervention (within 4 weeks before the commencement of parenting program)

  • Parents' psychological well-being

    Depression Anxiety Stress Scale 21 (DASS 21) \[Min. Value: 0; Max Value: 3 (with higher score indicating more symptoms of depression, anxiety or stress in the respective subscale)\]

    Immediate Post-intervention (within 4 weeks after the completion of parenting program)

  • Parents' psychological well-being

    Depression Anxiety Stress Scale 21 (DASS 21) \[Min. Value: 0; Max Value: 3 (with higher score indicating more symptoms of depression, anxiety or stress in the respective subscale)\]

    Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)

  • Parenting stress

    Parenting Stress Index - Short Form (PSI-SF) \[Min. Value: 1; Max Value: 5 (with higher score indicating higher parental distress or more perceived problems in a particular subscale)\]

    Pre-intervention (within 4 weeks before the commencement of parenting program)

  • Parenting stress

    Parenting Stress Index - Short Form (PSI-SF) \[Min. Value: 1; Max Value: 5 (with higher score indicating higher parental distress or more perceived problems in a particular subscale)\]

    Immediate Post-intervention (within 4 weeks after the completion of parenting program)

  • Parenting stress

    Parenting Stress Index - Short Form (PSI-SF) \[Min. Value: 1; Max Value: 5 (with higher score indicating higher parental distress or more perceived problems in a particular subscale)\]

    Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)

  • Parents' emotion regulation

    Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) \[Min. Value: 1; Max Value: 5 (with higher score indicating poorer emotional regulation)\]

    Pre-intervention (within 4 weeks before the commencement of parenting program)

  • Parents' emotion regulation

    Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) \[Min. Value: 1; Max Value: 5 (with higher score indicating poorer emotional regulation)\]

    Immediate Post-intervention (within 4 weeks after the completion of parenting program)

  • Parents' emotion regulation

    Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) \[Min. Value: 1; Max Value: 5 (with higher score indicating poorer emotional regulation)\]

    Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)

  • Children's emotion regulation

    Emotion Regulation Index of The Behavior Rating Inventory of Executive Function - Second Edition (BRIEF2) \[Min. Value: 1; Max Value: 3 (with higher score indicating more problems in children's emotion regulation)\]

    Pre-intervention (within 4 weeks before the commencement of parenting program)

  • Children's emotion regulation

    Emotion Regulation Index of The Behavior Rating Inventory of Executive Function - Second Edition (BRIEF2) \[Min. Value: 1; Max Value: 3 (with higher score indicating more problems in children's emotion regulation)\]

    Immediate Post-intervention (within 4 weeks after the completion of parenting program)

  • Children's emotion regulation

    Emotion Regulation Index of The Behavior Rating Inventory of Executive Function - Second Edition (BRIEF2) \[Min. Value: 1; Max Value: 3 (with higher score indicating more problems in children's emotion regulation)\]

    Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)

Secondary Outcomes (12)

  • Parent-child relationship

    Pre-intervention (within 4 weeks before the commencement of parenting program)

  • Parent-child relationship

    Immediate Post-intervention (within 4 weeks after the completion of parenting program)

  • Parent-child relationship

    Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)

  • Children's inattention, hyperactivity and impulsivity symptoms

    Pre-intervention (within 4 weeks before the commencement of parenting program)

  • Children's inattention, hyperactivity and impulsivity symptoms

    Immediate Post-intervention (within 4 weeks after the completion of parenting program)

  • +7 more secondary outcomes

Study Arms (3)

Mindful Parenting Program

EXPERIMENTAL

The Mindful Parenting program as developed by Bögels and Restifo (2013), is selected as one of the parenting intervention programs in this study. It is an 8-week program that trains parents in mindfulness and support them to apply mindfulness in parenting context.

Behavioral: Mindful Parenting, Tuning in to Kids

Tuning in to Kids Program

EXPERIMENTAL

The Tuning in to Kids program as developed by Havighurst and colleagues (2010), is selected as one of the parenting intervention programs in this study. It will be extended to 8-week program that aims at equipping parents with emotion coaching skills.

Behavioral: Mindful Parenting, Tuning in to Kids

Waitlist Control Group

NO INTERVENTION

The waitlist control group will not receive any intervention until the intervention arms complete their training. Depending on the availability of the program instructor, either the Mindful Parenting or Tuning in to Kids program will be offered to this group.

Interventions

The Mindful Parenting program consists of 8 weekly 2.5-hour group sessions and 3 weekly individual telephone interview sessions (each lasts for around 15-20 minutes). Program materials are translated into Chinese by local partners of the program developer. The Tuning in to Kids program consists of 8 weekly sessions, each lasting for 2.5 hours. Program materials are translated into Chinese.

Mindful Parenting ProgramTuning in to Kids Program

Eligibility Criteria

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

You may qualify if:

  • The parent who has a child with the diagnosis of AD/HD made by qualified professionals. The child does not have co-morbid developmental disabilities such as Autism Spectrum Disorder and Intellectual Disability.
  • The child is attending P.1 to P.4 in local primary schools, age between 6 and 10.

You may not qualify if:

  • Parent who has previously received training in Mindful Parenting, Tuning in to Kids, or other 8-weeks mindfulness program.
  • Parent who has serious mental health condition that rendering him/her incapable of participating in the intervention program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Anastopoulos, A. D., Smith, T. F., Garrett, M. E., Morrissey-Kane, E., Schatz, N. K., Sommer, J. L., & Ashley-Koch, A. (2011). Self-regulation of emotion, functional impairment, and comorbidity among children with AD/HD. Journal of attention disorders, 15(7), 583-592. Barkley, R. A., & Fischer, M. (2010). The unique contribution of emotional impulsiveness to impairment in major life activities in hyperactive children as adults. Journal of the American Academy of Child & Adolescent Psychiatry, 49(5), 503-513. Beer, M., Ward, L., & Moar, K. (2013). The relationship between mindful parenting and distress in parents of children with an autism spectrum disorder. Mindfulness, 4(2), 102-112. Biederman, J., Spencer, T. J., Petty, C., Hyder, L. L., O'Connor, K. B., Surman, C. B., & Faraone, S. V. (2012). Longitudinal course of deficient emotional self-regulation CBCL profile in youth with ADHD: prospective controlled study. Neuropsychiatric disease and treatment, 8, 267. Bögels, S., Hoogstad, B., van Dun, L., de Schutter, S., & Restifo, K. (2008). Mindfulness training for adolescents with externalizing disorders and their parents. Behavioural and cognitive psychotherapy, 36(2), 193. Bögels, S. M., Hellemans, J., van Deursen, S., Römer, M., & van der Meulen, R. (2014). Mindful parenting in mental health care: effects on parental and child psychopathology, parental stress, parenting, coparenting, and marital functioning. Mindfulness, 5(5), 536-551. Bögels, S. M., Lehtonen, A., & Restifo, K. (2010). Mindful parenting in mental health care. Mindfulness, 1(2), 107-120. Bögels, S., & Restifo, K. (2013). Mindful parenting: A guide for mental health practitioners. Springer Science & Business Media. Gouveia, M. J., Carona, C., Canavarro, M. C., & Moreira, H. (2016). Self-compassion and dispositional mindfulness are associated with parenting styles and parenting stress: The mediating role of mindful parenting. Mindfulness, 7(3), 700-712. Havighurst, S. S., Wilson, K. R., Harley, A. E., Prior, M. R., & Kehoe, C. (2010). Tuning in to Kids: improving emotion socialization practices in parents of preschool children-findings from a community trial. Journal of Child Psychology and Psychiatry, 51(12), 1342-1350. Havighurst, S. S., Wilson, K. R., Harley, A. E., Kehoe, C., Efron, D., & Prior, M. R. (2013). "Tuning into Kids": Reducing young children's behavior problems using an emotion coaching parenting program. Child Psychiatry & Human Development, 44(2), 247-264. Leinonen, J. A., Solantaus, T. S., & Punamäki, R. L. (2003). Parental mental health and children's adjustment: The quality of marital interaction and parenting as mediating factors. Journal of child psychology and psychiatry, 44(2), 227-241. Podolski, C. L., & Nigg, J. T. (2001). Parent stress and coping in relation to child ADHD severity and associated child disruptive behavior problems. Journal of clinical child psychology, 30(4), 503-513. Shaw, P., Stringaris, A., Nigg, J., & Leibenluft, E. (2014). Emotion dysregulation in attention deficit hyperactivity disorder. American Journal of Psychiatry, 171(3), 276-293. Singh, N. N., Lancioni, G. E., Winton, A. S., Singh, J., Singh, A. N., Adkins, A. D., & Wahler, R. G. (2010). Training in mindful caregiving transfers to parent-child interactions. Journal of Child and Family Studies, 19(2), 167-174. Townshend, K., Jordan, Z., Stephenson, M., & Tsey, K. (2016). The effectiveness of mindful parenting programs in promoting parents' and children's wellbeing: a systematic review. JBI database of systematic reviews and implementation reports, 14(3), 139-180. Van der Oord, S., Prins, P. J., Oosterlaan, J., & Emmelkamp, P. M. (2008). Efficacy of methylphenidate, psychosocial treatments and their combination in school-aged children with ADHD: a meta-analysis. Clinical psychology review, 28(5), 783-800. Van der Oord, S., Bögels, S. M., & Peijnenburg, D. (2012). The effectiveness of mindfulness training for children with ADHD and mindful parenting for their parents. Journal of child and family studies, 21(1), 139-147. Webster-Stratton, C. H., Reid, M. J., & Beauchaine, T. (2011). Combining parent and child training for young children with ADHD. Journal of Clinical Child & Adolescent Psychology, 40(2), 191-203. Zhang, D., Chan, S. K. C., Lo, H. H. M., Chan, C. Y. H., Chan, J. C. Y., Ting, K. T., & Wong, S. Y. S. (2017). Mindfulness-based intervention for Chinese children with ADHD and their parents: a pilot mixed-method study. Mindfulness, 8(4), 859-872.

    BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityEmotional Regulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersSelf-ControlSocial BehaviorBehavior

Study Officials

  • Iris Kit Yee LAM

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants do not have prior knowledge of the interventions that they will be assigned to. The research assistants who support data collection do not know the interventions assigned to individual participants.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized controlled design will be adopted. There will be two intervention groups, namely Mindful Parenting group and Tuning in to Kids group, and also one waitlist control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2021

First Posted

August 11, 2021

Study Start

September 1, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

November 3, 2022

Record last verified: 2021-07

Locations