Parent-Child RelationshipNCT02366000
An Intervention Study: Shaping a Healthier Child
A study testing Brief Parental Training Intervention in people with Parent-Child Relationship, run by The Hong Kong Polytechnic University.
Trial summary
The aim of this study is to identify parent-children communication in relation to health risk behaviors (smoking, drinking and illegal drug taking) in adolescents, and to enhance better parental skills in preventing these behaviors in children. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relationship
- What is being tested?
- Brief Parental Training Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Feb 2015
- 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
- Parent of a child in primary five or six
- Cantonese-speaking
- Consent to their participation in the program and the inclusion of their children in the assessments
Who cannot join
- none
About this study
Official title: A Randomized Controlled Trial of a Brief Intervention by Parents to Prevent Their Children From Experimenting With Health Risk Behavior: a Pilot Study
The aim of this study is to identify parent-children communication in relation to health risk behaviors (smoking, drinking and illegal drug taking) in adolescents, and to enhance better parental skills in preventing these behaviors in children.
Read the detailed description
Previous research found that parent-children communication is the best predictor of health risk behaviors among adolescents. However, longitudinal studies of parent-adolescent communication on the subject of health risk behavior such as alcohol, tobacco and other drug use (ATOD) remain relatively scarce, and none of this kind of work has been done among Chinese sample. Such information is urgently needed given the increasing trend of drug use among adolescents in Hong Kong, and the severe burden of morbidity and mortality related to ATOD.
The study aims to examine parent-children communication in relation to health risk behaviors and to explore the potential efficacy of a brief intervention which is designed to assist parents of primary school children to communicate with their children about issues in the prevention of health risk behaviors. The efficacy of the intervention will be compared with a waiting-list control group using a randomized controlled trial. There will then be two telephone follow-ups to reinforce learnt strategies and skills for home practice in between the two workshops. There will also be assessments post-intervention and at 1 year follow-up. Evaluation focus groups will also be conducted after the intervention program.
- Conditions
- Parent-Child Relationship
- Being tested
- Brief Parental Training Intervention
- Keywords
- Parent-child communication, Health risk behaviors, Randomized controlled trial
- Medical subject headings
- Health Risk Behaviors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Parental Training InterventionOther
The workshop was designed to assist parents to communicate with their children about issues in the prevention of health risk behaviours- alcohol, tobacco and other drug use (ATOD), by equipping them with the appropriate interaction skills and encouraging them to build relationships with their children.
| Study group | Role | What they receive |
|---|---|---|
| Brief Parental Training Intervention | Experimental | Participants will have to attend two 3-hour Brief Parental Training Intervention Programme, with three weeks apart. There will also be two telephone follow-up sessions to reinforce learnt strategies and skills for home practice between workshops. Receives: Other: Brief Parental Training Intervention |
| Wait-list Group | Other | Participants will receive the same Brief Parental Training Intervention Programme as the intervention group. However, they will wait until the questionnaires have been completed by the intervention group for the second time (i.e. immediately after intervention) before they receive their programme. Receives: Other: Brief Parental Training Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readiness of parents to communicate with their children about preventing health risk behaviour
Measured by Parent Questionnaire (PQ) - the sections on their (a) intention to take action, (b) self-efficacy in taking action, (c) plan of the action, (d) action to change (modified from Sniehotta, Scholz et al. 2002).
Measured: At 1 year
Secondary outcomes (4)
Quality of parent-child communication
Measured by Parent Questionnaire (PQ)- the section on parent-adolescent communication (Caprara, Pastorelli, Regalia, Scabini \& Bandura, 2005) as well as the Chidren Questionnaire (CQ)- the section on parent-adolescent communication (Caprara et al, 2005)
Measured: At 1 year
Parents' attitudes towards positive parenting
Measured by Parent Questionnaire (PQ)- the section on parenting patterns (Rohner, 1986; Chen, Rubin \& Li, 1997)
Measured: At 1 year
Quality of parent-child relationships
Measured by Parent Questionnaire (PQ)- the section on parent-child relationships (Schumm, Paff-Bergen et al., 1986) as well as the section on Children Questionnaire (CQ)- the section on parent-child relationships Schumm et al., 1986)
Measured: At 1 year
Children's health risk behaviour
Measured by Children Questionnaire (CQ)- the sections on health risk behaviour - smoking (Mak et al, 2005; Abdullah et al, 2006); alcohol use (Ewing, 1984); and illicit drug use (Kolbe, Kann \& Collins, 1999; Lee \& Tsang, 2004)
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationshipStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Sheng Kung Hui Tung Chung Integrated Services
- Responsible party
- Principal investigator, Dr. Yim Wah Mak, The Hong Kong Polytechnic University
- Investigators
- YW Mak, PHD, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366000
- Sponsor's protocol ID
- AP-J86
- Status last verified
- Feb 2015
- First submitted
- 6 Feb 2015
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Caprara GV, Pastorelli C, Regalia C, Scabini & Bandura A. (2005). Impact of adolescents' Filial self-efficacy on quality of family functioning and satisfaction. Journal of Research on Adolescence. 15(1). 71-97.
Rohner, R. P. (1984). Handbook for the study of parental acceptance and rejection (Rev. Ed.). Storrs: Center for the Study of Parental Acceptance and Rejection, University of Connecticut
Schumm, W. R., Paff-Bergen, L. A., Hatch, R. C., Obiorah, F. C., Copeland, J. M., Meens, L. D., et al. (1986). Concurrent and Discriminant Validity of the Kansas Marital Satisfaction Scale. Journal of Marriage and the Family, 48,381-387.
Sniehotta, F.F., Scholz, U., Lippke, S. & Zielmann, J. (2002). Scale for assessment of implementation planning and coping planning. http://userpage.fu-berlin.de/~falko/scales/heartdocu.html
Abdullah AS, Mak YW, Loke AY, Lam TH. Smoking cessation intervention in parents of young children: a randomised controlled trial. Addiction. 2005 Nov;100(11):1731-40. doi: 10.1111/j.1360-0443.2005.01231.x.
PubMed 16277633Mak YW, Loke AY, Lam TH, Abdullah AS. Validity of self-reports and reliability of spousal proxy reports on the smoking behavior of Chinese parents with young children. Addict Behav. 2005 May;30(4):841-5. doi: 10.1016/j.addbeh.2004.08.008.
PubMed 15833586Ewing JA. Detecting alcoholism. The CAGE questionnaire. JAMA. 1984 Oct 12;252(14):1905-7. doi: 10.1001/jama.252.14.1905.
PubMed 6471323Kolbe LJ, Kann L, Collins JL. Overview of the Youth Risk Behavior Surveillance System. Public Health Rep. 1993;108 Suppl 1(Suppl 1):2-10. No abstract available.
PubMed 8210269Lee A, Tsang CK. Youth risk behaviour in a Chinese population: a territory-wide youth risk behavioural surveillance in Hong Kong. Public Health. 2004 Mar;118(2):88-95. doi: 10.1016/S0033-3506(03)00174-4.
PubMed 15037037
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Brief Intervention by Parents to Prevent Their Children From Experimenting With Health Risk Behavior: a Pilot Study
- ClinicalTrials.gov ID
- NCT02366000
- Acronym / sponsor ID
- AP-J86
- Conditions
- Parent-Child Relationship
- Keywords
- Parent-child communication, Health risk behaviors, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Hong Kong Sheng Kung Hui Tung Chung Integrated Services
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Feb 2015 (estimated)
- 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.
The aim of this study is to identify parent-children communication in relation to health risk behaviors (smoking, drinking and illegal drug taking) in adolescents, and to enhance better parental skills in preventing these behaviors in children.
Detailed description
Previous research found that parent-children communication is the best predictor of health risk behaviors among adolescents. However, longitudinal studies of parent-adolescent communication on the subject of health risk behavior such as alcohol, tobacco and other drug use (ATOD) remain relatively scarce, and none of this kind of work has been done among Chinese sample. Such information is urgently needed given the increasing trend of drug use among adolescents in Hong Kong, and the severe burden of morbidity and mortality related to ATOD.
The study aims to examine parent-children communication in relation to health risk behaviors and to explore the potential efficacy of a brief intervention which is designed to assist parents of primary school children to communicate with their children about issues in the prevention of health risk behaviors. The efficacy of the intervention will be compared with a waiting-list control group using a randomized controlled trial. There will then be two telephone follow-ups to reinforce learnt strategies and skills for home practice in between the two workshops. There will also be assessments post-intervention and at 1 year follow-up. Evaluation focus groups will also be conducted after the intervention program.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Parental Training Intervention | Experimental | Other: Brief Parental Training InterventionParticipants will have to attend two 3-hour Brief Parental Training Intervention Programme, with three weeks apart. There will also be two telephone follow-up sessions to reinforce learnt strategies and skills for home practice between workshops. |
| Wait-list Group | Other | Other: Brief Parental Training InterventionParticipants will receive the same Brief Parental Training Intervention Programme as the intervention group. However, they will wait until the questionnaires have been completed by the intervention group for the second time (i.e. immediately after intervention) before they receive their programme. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parent of a child in primary five or six
- Cantonese-speaking
- Consent to their participation in the program and the inclusion of their children in the assessments
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Brief Parental Training InterventionThe workshop was designed to assist parents to communicate with their children about issues in the prevention of health risk behaviours- alcohol, tobacco and other drug use (ATOD), by equipping them with the appropriate interaction skills and encouraging them to build relationships with their children. | Other | Brief Parental Training Intervention, Wait-list Group |
Primary outcome
Readiness of parents to communicate with their children about preventing health risk behaviour
Time frame: At 1 year
Measured by Parent Questionnaire (PQ) - the sections on their (a) intention to take action, (b) self-efficacy in taking action, (c) plan of the action, (d) action to change (modified from Sniehotta, Scholz et al. 2002).
4 secondary outcomes
Quality of parent-child communication
Time frame: At 1 year
Parents' attitudes towards positive parenting
Time frame: At 1 year
Quality of parent-child relationships
Time frame: At 1 year
Children's health risk behaviour
Time frame: At 1 year
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 19 Feb 2015.
- BackgroundCaprara GV, Pastorelli C, Regalia C, Scabini & Bandura A. (2005). Impact of adolescents' Filial self-efficacy on quality of family functioning and satisfaction. Journal of Research on Adolescence. 15(1). 71-97.
- BackgroundRohner, R. P. (1984). Handbook for the study of parental acceptance and rejection (Rev. Ed.). Storrs: Center for the Study of Parental Acceptance and Rejection, University of Connecticut
- BackgroundSchumm, W. R., Paff-Bergen, L. A., Hatch, R. C., Obiorah, F. C., Copeland, J. M., Meens, L. D., et al. (1986). Concurrent and Discriminant Validity of the Kansas Marital Satisfaction Scale. Journal of Marriage and the Family, 48,381-387.
- BackgroundSniehotta, F.F., Scholz, U., Lippke, S. & Zielmann, J. (2002). Scale for assessment of implementation planning and coping planning. http://userpage.fu-berlin.de/~falko/scales/heartdocu.html
- Background: PubMed 16277633Abdullah AS, Mak YW, Loke AY, Lam TH. Smoking cessation intervention in parents of young children: a randomised controlled trial. Addiction. 2005 Nov;100(11):1731-40. doi: 10.1111/j.1360-0443.2005.01231.x.
- Background: PubMed 15833586Mak YW, Loke AY, Lam TH, Abdullah AS. Validity of self-reports and reliability of spousal proxy reports on the smoking behavior of Chinese parents with young children. Addict Behav. 2005 May;30(4):841-5. doi: 10.1016/j.addbeh.2004.08.008.
- Background: PubMed 6471323Ewing JA. Detecting alcoholism. The CAGE questionnaire. JAMA. 1984 Oct 12;252(14):1905-7. doi: 10.1001/jama.252.14.1905.
- Background: PubMed 8210269Kolbe LJ, Kann L, Collins JL. Overview of the Youth Risk Behavior Surveillance System. Public Health Rep. 1993;108 Suppl 1(Suppl 1):2-10. No abstract available.
- Background: PubMed 15037037Lee A, Tsang CK. Youth risk behaviour in a Chinese population: a territory-wide youth risk behavioural surveillance in Hong Kong. Public Health. 2004 Mar;118(2):88-95. doi: 10.1016/S0033-3506(03)00174-4.
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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.
YW Mak, PHD principal investigator
School of Nursing, The Hong Kong Polytechnic University
Questions about this trial
What is this clinical trial studying?
A study testing Brief Parental Training Intervention in people with Parent-Child Relationship, run by The Hong Kong Polytechnic University.
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 3 inclusion and 1 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 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Readiness of parents to communicate with their children about preventing health risk behaviour (time frame: At 1 year). 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 NCT02366000, which also lists 9 linked publications.
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 19 Feb 2015.