Parenting InterventionNCT04999514
Examining the Effects of Parenting Interventions on Children With Attention-Deficit / Hyperactivity Disorder (AD/HD) and Their Parents
A study testing Mindful Parenting, Tuning in to Kids in people with Parenting Intervention and ADHD, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parenting Intervention, ADHD, Emotion Regulation
- What is being tested?
- Mindful Parenting, Tuning in to Kids
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Attention-Deficit / Hyperactivity Disorder (AD/HD) is one of the most common neurodevelopmental disorders affecting children and adolescents. Core symptoms of inattention, hyperactivity and impulsivity are associated with impairments in multiple aspects of functioning. Apart from the cognitive and behavioral symptoms listed in the diagnostic manual, emotional symptoms are often observed by the parents and teachers and commonly reported in behavioral rating scales. The prevalence of emotion-related problems among children and adolescents diagnosed with AD/HD is estimated to be between 24-50%. Emotion regulation problems in children and youths with AD/HD were associated with greater risk for more psychopathology, poorer psychosocial functioning, and increased rate of treatment service utilization. Follow-up study of children with AD/HD into adulthood found a higher prevalence of difficulties in emotion regulation among those with persistent AD/HD symptoms than those without.
Parenting a child with special needs such as AD/HD is known to be associated with increased level of parental stress. Apart from their jobs and other family duties, the parents must meet the challenges of taking care of their children's special needs and dealing with their functional problems. According to a survey conducted by the Centre for Special Educational Needs and Inclusive Education of the Educational University of Hong Kong in 2018, 82% of the parents of children with AD/HD experienced higher level of stress in relation to their children's symptoms, and over half of them reported to have mood problems. The parents often reported great frustrations in bringing up their children with limited support and encountering difficulties in daily interactions with their children. Previous research has demonstrated that parental mental health problems can adversely affect their parenting abilities and their children's adjustment.
Medication and behavioral treatment are the two evidence-based treatments for children with AD/HD. Apart from them, there are programs offered by public hospitals, government departments, and non-governmental organizations on teaching the parents skills to manage behavioral problems of children with AD/HD. However, parents may experience difficulties in applying these behavioral management skills when they are suffering from significant distress. In the recent years, new approaches such as mindfulness and emotion coaching have been applied to parenting intervention programs. Intervention studies have supported that these new parenting approaches have not only brought benefits to the parenting behaviors and parents' mental health but also to the children's behavioral problems and children's psychological well-being. Specific to the emotion regulation of children with AD/HD, the effect of behavioral management parent training has been examined in the previous research. However, there has been very limited intervention study which directly investigates the effect of new parenting intervention approaches on improving the emotion regulation of children.
In the present study, we propose to apply two parenting interventions for improving emotion regulation of children with AD/HD as well as their parents' parenting practices and psychological well-being. The two selected interventions are "Mindful Parenting" program and "Tuning into Kids" program. Using mindfulness techniques and everyday practice, the former intervention aims at helping parents cultivate awareness and self-regulation in parent-child interactions, bring compassion and non-judgmental acceptance to their difficulties. The latter intervention teaches the parents emotion coaching techniques to become more aware and reduce automatic response patterns to their children's emotions, and to communicate understanding of such emotions to children. Research has showed that these two new approaches are related to lower level of parental stress and reactivity, and fewer negative parent-child interactions.
Study Objectives:
- To evaluate the effects of the two parenting interventions on improving emotion regulation of children with AD/HD as well as their functioning.
- To evaluate the effects of the two parenting interventions in promoting parents' parenting practices and psychological well-being, which includes their emotion regulation, parenting stress, and mental health conditions.
Hypotheses:
- It is hypothesized that improvements in emotion regulation and functioning will be observed among children whose parents have completed one of the parenting interventions. Some of the improvements will be sustained in the two-months post-intervention assessment.
- It is expected that the parents who have completed the one of the parenting interventions will show improvements in their parenting practices and psychological well-being. The improvements will be showed immediately after the intervention, and some of the gains will also be sustained in the two-months post-intervention assessment.
- Conditions
- Parenting Intervention, ADHD, Emotion Regulation
- Being tested
- Mindful Parenting, Tuning in to Kids
- Keywords
- Mindful parenting, Emotion coaching, Parenting practice, Parenting stress
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Parenting, Tuning in to KidsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindful parenting practice
Interpersonal Mindfulness in Parenting (IM-P) [Min. Value: 1; Max Value: 5 (with higher score indicating higher level of mindful parenting)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)
Secondary outcomes (12)
Parent-child relationship
Parent-Child Relationship Factor in the Parenting and Family Adjustment Scales (PAFAS) [Min. Value: 0; Max Value: 3 (with higher score indicating better parent child relationship)]
Measured: Pre-intervention (within 4 weeks before the commencement of parenting program)
Parent-child relationship
Parent-Child Relationship Factor in the Parenting and Family Adjustment Scales (PAFAS) [Min. Value: 0; Max Value: 3 (with higher score indicating better parent child relationship)]
Measured: Immediate Post-intervention (within 4 weeks after the completion of parenting program)
Parent-child relationship
Parent-Child Relationship Factor in the Parenting and Family Adjustment Scales (PAFAS) [Min. Value: 0; Max Value: 3 (with higher score indicating better parent child relationship)]
Measured: Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)
Children's inattention, hyperactivity and impulsivity symptoms
Swanson, Nolan, and Pelham Version IV Scale (SNAP-IV) [Min. Value: 0; Max Value: 3 (with higher score indicating more symptoms of inattention or hyperactivity/impulsivity in the respective subscale)]
Measured: Pre-intervention (within 4 weeks before the commencement of parenting program)
Children's inattention, hyperactivity and impulsivity symptoms
Swanson, Nolan, and Pelham Version IV Scale (SNAP-IV) [Min. Value: 0; Max Value: 3 (with higher score indicating more symptoms of inattention or hyperactivity/impulsivity in the respective subscale)]
Measured: Immediate Post-intervention (within 4 weeks after the completion of parenting program)
Children's inattention, hyperactivity and impulsivity symptoms
Swanson, Nolan, and Pelham Version IV Scale (SNAP-IV) [Min. Value: 0; Max Value: 3 (with higher score indicating more symptoms of inattention or hyperactivity/impulsivity in the respective subscale)]
Measured: Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)
Children's functioning
Strengths and Difficulties Questionnaire (SDQ) [Min. Value: 0; Max Value: 2 (with higher score indicating more child behavioral or social difficulties in a particular subscale)]
Measured: Pre-intervention (within 4 weeks before the commencement of parenting program)
Children's functioning
Strengths and Difficulties Questionnaire (SDQ) [Min. Value: 0; Max Value: 2 (with higher score indicating more child behavioral or social difficulties in a particular subscale)]
Measured: Immediate Post-intervention (within 4 weeks after the completion of parenting program)
Children's functioning
Strengths and Difficulties Questionnaire (SDQ) [Min. Value: 0; Max Value: 2 (with higher score indicating more child behavioral or social difficulties in a particular subscale)]
Measured: Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)
General parenting practice
Multidimensional Assessment of Parenting Scale (MAPS) [Min. Value: 1; Max Value: 5 (with higher score indicating higher frequency of the parenting behaviours in a particular subscale)]
Measured: Pre-intervention (within 4 weeks before the commencement of parenting program)
General parenting practice
Multidimensional Assessment of Parenting Scale (MAPS) [Min. Value: 1; Max Value: 5 (with higher score indicating higher frequency of the parenting behaviours in a particular subscale)]
Measured: Immediate Post-intervention (within 4 weeks after the completion of parenting program)
General parenting practice
Multidimensional Assessment of Parenting Scale (MAPS) [Min. Value: 1; Max Value: 5 (with higher score indicating higher frequency of the parenting behaviours in a particular subscale)]
Measured: Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Sep 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parenting InterventionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iris Kit Yee LAM, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999514
- Sponsor's protocol ID
- EA200195
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet decided.
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Parenting Interventions on Children With Attention-Deficit / Hyperactivity Disorder (AD/HD) and Their Parents
- ClinicalTrials.gov ID
- NCT04999514
- Acronym / sponsor ID
- EA200195
- Conditions
- Parenting Intervention, ADHD, Emotion Regulation
- Keywords
- Mindful parenting, Emotion coaching, Parenting practice, Parenting stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Attention-Deficit / Hyperactivity Disorder (AD/HD) is one of the most common neurodevelopmental disorders affecting children and adolescents. Core symptoms of inattention, hyperactivity and impulsivity are associated with impairments in multiple aspects of functioning. Apart from the cognitive and behavioral symptoms listed in the diagnostic manual, emotional symptoms are often observed by the parents and teachers and commonly reported in behavioral rating scales. The prevalence of emotion-related problems among children and adolescents diagnosed with AD/HD is estimated to be between 24-50%. Emotion regulation problems in children and youths with AD/HD were associated with greater risk for more psychopathology, poorer psychosocial functioning, and increased rate of treatment service utilization. Follow-up study of children with AD/HD into adulthood found a higher prevalence of difficulties in emotion regulation among those with persistent AD/HD symptoms than those without.
Parenting a child with special needs such as AD/HD is known to be associated with increased level of parental stress. Apart from their jobs and other family duties, the parents must meet the challenges of taking care of their children's special needs and dealing with their functional problems. According to a survey conducted by the Centre for Special Educational Needs and Inclusive Education of the Educational University of Hong Kong in 2018, 82% of the parents of children with AD/HD experienced higher level of stress in relation to their children's symptoms, and over half of them reported to have mood problems. The parents often reported great frustrations in bringing up their children with limited support and encountering difficulties in daily interactions with their children. Previous research has demonstrated that parental mental health problems can adversely affect their parenting abilities and their children's adjustment.
Medication and behavioral treatment are the two evidence-based treatments for children with AD/HD. Apart from them, there are programs offered by public hospitals, government departments, and non-governmental organizations on teaching the parents skills to manage behavioral problems of children with AD/HD. However, parents may experience difficulties in applying these behavioral management skills when they are suffering from significant distress. In the recent years, new approaches such as mindfulness and emotion coaching have been applied to parenting intervention programs. Intervention studies have supported that these new parenting approaches have not only brought benefits to the parenting behaviors and parents' mental health but also to the children's behavioral problems and children's psychological well-being. Specific to the emotion regulation of children with AD/HD, the effect of behavioral management parent training has been examined in the previous research. However, there has been very limited intervention study which directly investigates the effect of new parenting intervention approaches on improving the emotion regulation of children.
In the present study, we propose to apply two parenting interventions for improving emotion regulation of children with AD/HD as well as their parents' parenting practices and psychological well-being. The two selected interventions are "Mindful Parenting" program and "Tuning into Kids" program. Using mindfulness techniques and everyday practice, the former intervention aims at helping parents cultivate awareness and self-regulation in parent-child interactions, bring compassion and non-judgmental acceptance to their difficulties. The latter intervention teaches the parents emotion coaching techniques to become more aware and reduce automatic response patterns to their children's emotions, and to communicate understanding of such emotions to children. Research has showed that these two new approaches are related to lower level of parental stress and reactivity, and fewer negative parent-child interactions.
Study Objectives:
- To evaluate the effects of the two parenting interventions on improving emotion regulation of children with AD/HD as well as their functioning.
- To evaluate the effects of the two parenting interventions in promoting parents' parenting practices and psychological well-being, which includes their emotion regulation, parenting stress, and mental health conditions.
Hypotheses:
- It is hypothesized that improvements in emotion regulation and functioning will be observed among children whose parents have completed one of the parenting interventions. Some of the improvements will be sustained in the two-months post-intervention assessment.
- It is expected that the parents who have completed the one of the parenting interventions will show improvements in their parenting practices and psychological well-being. The improvements will be showed immediately after the intervention, and some of the gains will also be sustained in the two-months post-intervention assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindful Parenting Program | Experimental | Behavioral: Mindful Parenting, Tuning in to KidsThe 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. |
| Tuning in to Kids Program | Experimental | Behavioral: Mindful Parenting, Tuning in to KidsThe 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Parenting, Tuning in to KidsThe 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. | Behavioural | Mindful Parenting Program, Tuning in to Kids Program |
Primary outcome
Mindful parenting practice
Time frame: Pre-intervention (within 4 weeks before the commencement of parenting program)
Interpersonal Mindfulness in Parenting (IM-P) [Min. Value: 1; Max Value: 5 (with higher score indicating higher level of mindful parenting)]
Mindful parenting practice
Time frame: Immediate Post-intervention (within 4 weeks after the completion of parenting program)
Interpersonal Mindfulness in Parenting (IM-P) [Min. Value: 1; Max Value: 5 (with higher score indicating higher level of mindful parenting)]
Mindful parenting practice
Time frame: Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)
Interpersonal Mindfulness in Parenting (IM-P) [Min. Value: 1; Max Value: 5 (with higher score indicating higher level of mindful parenting)]
Emotion coaching practice
Time frame: Pre-intervention (within 4 weeks before the commencement of parenting program)
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)]
Emotion coaching practice
Time frame: Immediate Post-intervention (within 4 weeks after the completion of parenting program)
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)]
Emotion coaching practice
Time frame: Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)
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)]
Parents' psychological well-being
Time frame: Pre-intervention (within 4 weeks before the commencement of parenting program)
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)]
Parents' psychological well-being
Time frame: Immediate Post-intervention (within 4 weeks after the completion of parenting program)
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)]
Parents' psychological well-being
Time frame: Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)
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)]
Parenting stress
Time frame: Pre-intervention (within 4 weeks before the commencement of parenting program)
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)]
Parenting stress
Time frame: Immediate Post-intervention (within 4 weeks after the completion of parenting program)
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)]
Parenting stress
Time frame: Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)
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)]
Parents' emotion regulation
Time frame: Pre-intervention (within 4 weeks before the commencement of parenting program)
Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) [Min. Value: 1; Max Value: 5 (with higher score indicating poorer emotional regulation)]
Parents' emotion regulation
Time frame: Immediate Post-intervention (within 4 weeks after the completion of parenting program)
Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) [Min. Value: 1; Max Value: 5 (with higher score indicating poorer emotional regulation)]
Parents' emotion regulation
Time frame: Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)
Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) [Min. Value: 1; Max Value: 5 (with higher score indicating poorer emotional regulation)]
Children's emotion regulation
Time frame: Pre-intervention (within 4 weeks before the commencement of parenting program)
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)]
Children's emotion regulation
Time frame: Immediate Post-intervention (within 4 weeks after the completion of parenting program)
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)]
Children's emotion regulation
Time frame: Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)
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)]
12 secondary outcomes
Parent-child relationship
Time frame: Pre-intervention (within 4 weeks before the commencement of parenting program)
Parent-child relationship
Time frame: Immediate Post-intervention (within 4 weeks after the completion of parenting program)
Parent-child relationship
Time frame: Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)
Children's inattention, hyperactivity and impulsivity symptoms
Time frame: Pre-intervention (within 4 weeks before the commencement of parenting program)
Children's inattention, hyperactivity and impulsivity symptoms
Time frame: Immediate Post-intervention (within 4 weeks after the completion of parenting program)
Children's inattention, hyperactivity and impulsivity symptoms
Time frame: Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)
Children's functioning
Time frame: Pre-intervention (within 4 weeks before the commencement of parenting program)
Children's functioning
Time frame: Immediate Post-intervention (within 4 weeks after the completion of parenting program)
Children's functioning
Time frame: Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)
General parenting practice
Time frame: Pre-intervention (within 4 weeks before the commencement of parenting program)
General parenting practice
Time frame: Immediate Post-intervention (within 4 weeks after the completion of parenting program)
General parenting practice
Time frame: Delayed Post-intervention (follow-up 2 months later, waitlist control group not included)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- BackgroundAnastopoulos, 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.
- Individual participant dataSharing planned: Undecided. Not yet decided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iris Kit Yee LAM principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Parenting, Tuning in to Kids in people with Parenting Intervention and ADHD, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindful parenting practice (time frame: Pre-intervention (within 4 weeks before the commencement of parenting program)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04999514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.