Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00482

2 Trial Registration Date

2015-10-28

i Registration Status

Prospective

3 Secondary IDs

3-3-201412

4 Source(s) of Funding

Social Welfare Development Fund

5 Primary Sponsor

City University of Hong Kong

6 Secondary Sponsor

Heep Hong Society

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

Universal prevention parenting programme in applying mindfulness training in parents with special needs children

10 Public Title

A brief parenting programme in applying mindfulness training in parents with special needs children

i Public Title in Chinese 研究名稱

應用於特殊需要兒童家長的靜觀訓練課程

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?

2015-01-08

iii Full Name of IRB/IEC

Other

Please specify

Research Grants & Contracts Office, City University of Hong Kong

iv IRB/IEC approval reference number

3-3-201412

14 Medical Condition Being Studied

depression

stress

15 Intervention

i Types of intervention

Other

Please specify

Mindfulness-based intervention

ii Description/ name of Intervention/article

The programme applies mindfulness training. The content is adjusted with the needs of parents having children with special needs. The programme has six 1.5-hour weekly sessions in group setting, and contains the exercises of mindful breathing, mindful sitting, body scan, stretching, reflection, discussion and sharing.

iii Dosage form of the intervention

Behavioral

iv Dosage of the intervention

6 weeks

v Duration of the intervention

1.5 hour per week

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

Parents have children with special education needs aged 4 to 6.

ii Exclusion Criteria

Parents do not have special needs children.

iii Age Minimum

No limits

iv Age Maximum

No limits

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)

20 Anticipated trial start date

2015-11-01

21 Target Sample Size

100

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Depression

ii The metric or method of measurement used

Questionnaire: Center for Epidemiological Studies-Depression (CES-D)

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

Stress

ii The metric or method of measurement used

Questionnaire: Parenting Stress Index–Short Form (PSI–SF)

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

Interpersonal mindfulness in parenting

ii The metric or method of measurement used

Questionnaire: Interpersonal Mindfulness in Parenting Scale (IM-P)

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 problem

ii The metric or method of measurement used

Questionnaire: Eyberg Child Behavior Inventory (ECBI)

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

Marital satisfaction

ii The metric or method of measurement used

Questionnaire: Kansas Marital Satisfaction Scale (KMSS)

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