- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07403903
Amazing Start Parenting Program
Having an Amazing Start? A Randomized Controlled Trial Evaluating the Effectiveness of a Parenting Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There are strong relations between children's family background and their development. Infants and toddlers growing up in single-parent families, low-income families, and families with members having physical or mental health issues are less likely to meet developmental milestones at appropriate times compared to their peers who grow up in intact, well-off, and healthy families. The lack of parenting knowledge and skills is one of the potential factors that may explain the relation between children's family background and their development. Infants and toddlers growing up in at-risk families may face more stressors, and they may not have the means to acquire relevant parenting knowledge and skills that are important for children's development. Intervention programs that target parenting skills may help mitigate the negative effects of these risk factors on children's development.
Observing this service gap, the research team has developed a parenting program titled "Amazing Start". The program aims to improve infants' and toddlers' development through improving parents' parenting skills and reducing their parental stress. These interventions involve one-to-one coaching on parent-child interactions as well as parent support groups that are led by social workers. The intervention is delivered to those who have 2 or more of the risk factors listed below: (1) single-parent family, (2) ethnic minority, (3) new parents, (4) low-income family, (5) families with newborn twins, (6) persistent family conflicts, and (7) family members suffering from long-term illness.
A randomized controlled trial will be conducted to examine the effectiveness of the intervention. Families who are identified as having at least 2 risk factors will be randomly assigned to one of the two conditions. Families assigned to the experimental condition will receive the intervention for nine months, while families assigned to the wait-list control condition will not receive any services during this period. Pre-test and post-test will be conducted to assess the program's effectiveness in improving parental sense of competence, reducing parental stress, enhancing parents' satisfaction about parenting, as well as promoting infants' and toddlers' development. The wait-list control group will receive the parenting intervention after the post-test.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Region
-
Hong Kong, Region, Hong Kong
- The Univesity of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1. Families with infants and toddlers aged 0 to 36 months
- 2. Families residing in Kwun Tong, Yuen Long, and Yau Tsim Mong Districts
3. Families with at least 2 risk factors listed below
- single-parent family,
- ethnic minority,
- new parents,
- low-income family,
- families with newborn twins,
- persistent family conflicts, and
- family members suffering from long-term illness
Exclusion Criteria:
- Families with fewer than 2 risk factors listed above
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Amazing start parenting intervention
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|
|
No Intervention: Control
• No service is provided to the families in the control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child development
Time Frame: 9 months after the start of the intervention
|
Ages and stages questionnaire - third edition (ASQ-3).
The ASQ-3 is a brief screening tool for assessing young children's (aged 1 to 66 months) development in five different domains, namely communication, gross motor, fine motor, problem solving, and personal-social.
There are 6 items in each domain.
Each item involves a simple task in which the child needs to complete with the relevant materials.
As the ASQ-3 consists of different items for children of different age, the number of domains reaching the appropriate developmental milestones will be used as an overall indicator of the child's development.
|
9 months after the start of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parenting sense of competence
Time Frame: 9 months after the start of the intervention
|
Parenting sense of competence scale (Gibaud-Wallston & Wandersman, 1978; Ngai, et al., 2007).
This is a 17-item 6-point Likert scale assessing parents' sense of competence.
Total score is used in the analysis.
|
9 months after the start of the intervention
|
|
Parental stress
Time Frame: 9 months after the start of the intervention
|
Parental stress scale (Berry and Jones, 1995; translated to Chinese by Cheung, 2000).
This is a 17-item 6-point Likert scale assessing parental stress.
Total score is used in the analysis.
|
9 months after the start of the intervention
|
|
Parents' life satisfaction
Time Frame: 9 months after the start of the intervention
|
Satisfaction level on different life aspects.
This is a self-report life satisfaction questionnaire developed by the research team.
It covers various aspects ranging from parent's attitude towards parent-child interactions, the mastery of parenting knowledge and skills, family interaction patterns, as well as self-control of emotions.
Each domain is rated along a 11 point Likert scale, ranging from 0 (very unsatisfactory) to 10 (very satisfactory).
Total score is used in the analysis.
|
9 months after the start of the intervention
|
|
Cost effectiveness
Time Frame: 48 months after the start of the intervention
|
After the intervention, the research team will obtain information about the cost of service delivery in order to calculate the cost-effectiveness of the program.
Cost-effectiveness of the parenting program versus control will be assessed and expressed in terms of incremental cost per one unit gain in effectiveness.
|
48 months after the start of the intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EA230380
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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