Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00481

2 Trial Registration Date

2015-10-28

i Registration Status

Prospective

3 Secondary IDs

3-3-201504_03

4 Source(s) of Funding

Health Care and Promotion Fund, the Government of the Hong Kong Special Administrative Region

5 Primary Sponsor

City University of Hong Kong

6 Secondary Sponsor

Hong Kong Family Welfare Society, Christian Family Service Centre, Yang Memorial Methodist Social Service

Function

Take on all the responsibilities of sponsorship jointly with the primary sponsor

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Hay Ming Herman Lo

ii Address

B7409, AC1, City University of Hong Kong, Tat Chee Avenue, Kowloon Tong

iii Phone

34428116

iv Email

hm.lo@cityu.edu.hk

v Affiliation

Department of Applied Social Sciences, City University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Hay Ming Herman Lo

ii Address

B7409, AC1, City University of Hong Kong, Tat Chee Avenue, Kowloon Tong

iii Phone

34428116

iv Email

hm.lo@cityu.edu.hk

v Affiliation

Department of Applied Social Sciences, City University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Promoting wellbeing of families with children at-risk of Attention Deficit Hyperactivity Disorder (ADHD)

10 Public Title

Promoting wellbeing of families with children at-risk of Attention Deficit Hyperactivity Disorder (ADHD)

i Public Title in Chinese 研究名稱

提升專注力不足/過度活躍兒童及其家庭的身心健康

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-06-01

iii Full Name of IRB/IEC

Other

Please specify

Research Grants & Contracts Office, City University of Hong Kong

iv IRB/IEC approval reference number

3-3-201504_03

14 Medical Condition Being Studied

Attention Deficit Hyperactivity Disorder

15 Intervention

i Types of intervention

Other

Please specify

Mindfulness-based intervention

ii Description/ name of Intervention/article

This is a family-based intervention, including a parent programme and a children programme.

The design of the parent programme is based on mindfulness-based intervention. The content is adjusted with the special needs of parents having children with ADHD, or at risk of ADHD. The parent programme has six 1.5-hour weekly sessions in group setting, and the children programme has eight 1 hour weekly sessions in group setting. Both contains the exercises of mindful breathing, mindful sitting, bodyscan, stretching, reflection, discussion and sharing.

iii Dosage form of the intervention

Behavioral

iv Dosage of the intervention

6 weeks for parents and 8 weeks for children

v Duration of the intervention

1.5 hour per week for parents and 1 hour per week for children

vi Frequency of the intervention

Once per week

16 Comparative Treatments

i Description/ name of comparative treatments

Treatment as usual

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Children's age is 5 to 7.

Children reach the borderline cutoff scores of Strengths and Weaknesses of ADHD Symptoms and Normal Behaviours Rating Scale (SWAN).

Both parents and children are committed to join the program.

ii Exclusion Criteria

Children have autism, developmental delay or other developmental disorders which may influence the learning or the course of the lessons.

iii Age Minimum

5 for children; and no limits for parents

iv Age Maximum

7 for children; and no limits for parents

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

All participants are randomly assigned to the intervention group or waiting list group.

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

2

Please specify

vi Study Objectives (Optional)

Examine the feasibility of family-based mindfulness intervention in Chinese families with children at risk of ADHD

20 Anticipated trial start date

2015-11-01

21 Target Sample Size

100 children and 100 parents

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Parental stress

ii The metric or method of measurement used

Questionnaire: Parenting Stress Index Short Form

iii The timepoint(s) of primary interest

Pre-test before intervention, post-test after intervention and follow-up evaluation

Primary Outcome

i The Name of the outcome

Child ADHD problems

ii The metric or method of measurement used

Questionnaire: Strengths and Weaknesses of ADHD Symptoms and Normal Behavior Rating Scales

iii The timepoint(s) of primary interest

Pre-test before intervention, post-test after intervention and follow-up evaluation

Primary Outcome

i The Name of the outcome

Child attention

ii The metric or method of measurement used

Computer-based test: Child Attention Network Test

iii The timepoint(s) of primary interest

Pre-test before intervention, post-test after intervention and follow-up evaluation

24 Secondary Outcome

i The Name of the outcome

Parents' mindfulness in parenting

ii The metric or method of measurement used

Questionnaire: Interpersonal Mindfulness in Parenting

iii The timepoint(s) of primary interest

Pre-test before intervention, post-test after intervention and follow-up evaluation

Secondary Outcome

i The Name of the outcome

Parental ADHD problems

ii The metric or method of measurement used

Questionnaire: World Health Organization Adult ADHD Self-Report Scale

iii The timepoint(s) of primary interest

Pre-test before intervention, post-test after intervention and follow-up evaluation

Secondary Outcome

i The Name of the outcome

Heart rate variability of parents and children

ii The metric or method of measurement used

Apparatus-based measurement: A heart belt with an electronic watch

iii The timepoint(s) of primary interest

Pre-test before intervention, post-test after intervention and follow-up evaluation

Secondary Outcome

i The Name of the outcome

Child behavioral problems

ii The metric or method of measurement used

Questionnaire: Child Behavior Checklist

iii The timepoint(s) of primary interest

Pre-test before intervention, post-test after intervention and follow-up evaluation

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-04-05

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2015-10-28