- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06875713
Parenting for Lifelong Health Program in Kuwait
March 13, 2025 updated by: Hind Almazeedi, Ministry of Health, Kuwait
Parenting for Lifelong Health in Kuwait (DAYEM) - a Randomized Controlled Trial
Parenting interventions play a crucial role in promoting positive parent-child interactions, which are fundamental to fostering child well-being.
Over the years, substantial progress has been made in understanding the importance of these interactions, particularly in the context of early childhood development.
Positive parent-child interactions lay the groundwork for various aspects of child development, including socioemotional skills, academic performance, and mental health.
Evidence-based parenting programs have demonstrated strong effectiveness in promoting positive parenting and preventing child maltreatment.
The Parenting for Lifelong Health (PLH) program has yielded positive outcomes in many countries.
This project aims to culturally adapt the PLH program and conduct a randomized controlled trial (RCT) to assess its feasibility and effectiveness in Kuwait.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Safat, Kuwait, 13001
- Child Protection Office - Ministry of Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- A primary caregiver of children aged 2-9 years
- Over the age of 18.
- Kuwaiti
- Lives in Kuwait
- Speaks Arabic
Exclusion Criteria:
- Non-Arabic speakers
- Non-Kuwaitis
- Parent whose co-parent is participating in study
- Not resident of Kuwait
- Target child has mental disability or special needs
- Facilitator, supervisor, or caregiver contributor in the DAYEM program
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group
The intervention group will participate in eight in-person sessions of the PLH program, supplemented by the use of a digital parenting program (ParentApp) aimed at enhancing positive parenting behaviours.
|
This intervention consists of the Parenting for Lifelong Health (PLH) program, delivered through eight in-person sessions, supplemented by a digital parenting program (ParentApp).
The intervention aims to enhance positive parenting behaviors and reduce child maltreatment.
|
|
Active Comparator: control group
The control group will receive education on adult nutrition over the same period.
|
The control group will receive education on adult nutrition over the same period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parenting and Discipline Strategies
Time Frame: three time points: pre-intervention, post-intervention (one week after the intervention ends ), and four months post-intervention
|
This section measures the frequency of various discipline strategies used by parents or caregivers in the past 30 days (9 items), including physical (e.g., spanking, using objects, grabbing, pinching) and psychological (e.g., yelling, shaming, ignoring, threatening) disciplinary practices.
Responses range from 0 time to 8/8+ times, providing insight into parenting behaviors and disciplinary approaches.
|
three time points: pre-intervention, post-intervention (one week after the intervention ends ), and four months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic and Social Information
Time Frame: pre-intervention
|
This section measures demographic and socioeconomic characteristics, including age, gender, nationality, residence, number of children, marital and co-parenting status, education level, employment status, household income, and income satisfaction (11 items).
|
pre-intervention
|
|
Child Behavioral Concerns
Time Frame: three time points: pre-intervention, post-intervention (one week after the intervention ends ), and four months post-intervention
|
This section assesses child behavioral and emotional difficulties over the past 30 days (10 items), including irritability, anger, mood swings, defiance, dishonesty, aggression, disruptive behavior, destructiveness, cruelty, and minor theft.
Responses range from 0 (Not true) to 2 (Very true), providing insight into the child's behavioral tendencies and potential conduct issues.
|
three time points: pre-intervention, post-intervention (one week after the intervention ends ), and four months post-intervention
|
|
Parenting Experience and Well-Being
Time Frame: three time points: pre-intervention, post-intervention (one week after the intervention ends ), and four months post-intervention
|
This section measures parenting experience and well-being by assessing the frequency of positive parenting practices over the past 30 days (10 items).
It includes aspects such as quality time spent with the child, encouragement of problem-solving, engagement in fun activities, use of praise and rewards, involvement in household chores, clear communication of expectations, maintaining a calm tone, and providing explanations and preparation for challenging situations.
Responses range from 1 (Never) to 7 (Most of the time), reflecting caregivers' supportive and constructive parenting behaviors.
|
three time points: pre-intervention, post-intervention (one week after the intervention ends ), and four months post-intervention
|
|
Personal Mental Well-Being
Time Frame: three time points: pre-intervention, post-intervention (one week after the intervention ends ), and four months post-intervention
|
This section assesses personal mental well-being over the past 30 days, measuring the frequency of positive psychological states such as optimism, sense of purpose, relaxation, problem-solving ability, mental clarity, social connectedness, and decision-making confidence (7 items).
Responses range from 1 (Never) to 5 (All the time), providing insight into overall emotional resilience and well-being.
|
three time points: pre-intervention, post-intervention (one week after the intervention ends ), and four months post-intervention
|
|
Parenting Stress and Satisfaction
Time Frame: three time points: pre-intervention, post-intervention (one week after the intervention ends ), and four months post-intervention
|
This section measures parenting stress and satisfaction by assessing caregivers' emotional experiences and attitudes toward their parenting role.
It includes aspects of happiness, closeness, enjoyment, optimism, engagement with children, feelings of being overwhelmed, and potential regrets about having children (7 items).
Responses range from 1 (Strongly Disagree) to 5 (Strongly Agree), providing insight into caregivers' overall parenting experience and well-being.
|
three time points: pre-intervention, post-intervention (one week after the intervention ends ), and four months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2025
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
March 8, 2025
First Submitted That Met QC Criteria
March 8, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 13, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2024/2735
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
Clinical Trials on Child Development
-
SangathUNICEFCompletedChild Development | Child Nutrition and Early Child DevelopmentIndia
-
Yale UniversityRobinhood Foundation; Adelphi University; Docs for TotsCompletedSocial Skills | Child Behavior | Child Development | Infant DevelopmentUnited States
-
International Care Ministries, PhilippinesCompassion International, United States of AmericaNot yet recruitingChild Development | Child Nutrition, Child Neurobehavioral Development | Academic Attainment | Household and Family | Financial Wellbeing
-
University of Southern CaliforniaSafe Water and AIDS Project; Early Childhood Development Network for Kenya...Active, not recruitingChild Behavior | Child Development | Language, ChildKenya
-
Windward Islands Research and Education FoundationGrand Challenges Canada; St. George's University; GRENCASECompletedDevelopment, Child | Behavior, Child | Neurocognition, ChildGrenada
-
London School of Hygiene and Tropical MedicineInternational Centre for Diarrhoeal Disease Research, Bangladesh; University... and other collaboratorsActive, not recruitingChild Development | Child Development DisorderBangladesh, Tanzania, Nepal
-
Children's Hospital of PhiladelphiaNational Institute on Minority Health and Health Disparities (NIMHD)CompletedDevelopment Delay | Development, ChildUnited States
-
University of WashingtonRecruitingChild Behavior | Child DevelopmentUnited States
-
The Hospital for Sick ChildrenAga Khan University; March of DimesCompletedChild Development | Child Mortality | Child Morbidity | Child BehaviourPakistan
-
University Hospital, RouenRecruitingChild Development | Child Mental Disorder | Adolescent Behavior | Child Behavior Disorders | Behavior, Child | Adolescent Development | Adolescent - Emotional Problem | Child Development DisorderFrance
Clinical Trials on Parenting for Lifelong Health Program (DAYEM)
-
University of BremenUniversity of Oxford; University of Cape Town; Bangor University; Georgia State... and other collaboratorsCompletedChild Mental DisorderNorth Macedonia, Romania, Moldova, Republic of
-
Ateneo de Manila UniversityUniversity of Oxford; University of Cape Town; Philippines Department of Social... and other collaboratorsCompletedParent-Child Relations | Parenting | Child Behavior Problem | Child MaltreatmentPhilippines
-
Technische Universitaet BraunschweigUniversity of Oxford; University of Cape Town; Bangor University; Georgia State... and other collaboratorsCompletedChild Mental DisorderRomania, Macedonia, The Former Yugoslav Republic of, Moldova, Republic of
-
University of KlagenfurtCardiff University; Medical University of Vienna; Bielefeld University; Institute... and other collaboratorsRecruitingFamily Functioning | Adolescent - Emotional Problem | Parent Child Relationship | Well-Being, PsychologicalNorth Macedonia, Moldova
-
University of KlagenfurtCardiff University; Medical University of Vienna; Bielefeld University; Institute... and other collaboratorsCompletedParent-Child Relations | Parenting | Adolescent Behavior | Adolescent - Emotional Problem | Psychological Well-BeingMoldova, Republic of, North Macedonia
-
University of BremenUniversity of Oxford; University of Cape Town; Bangor University; Georgia State... and other collaboratorsCompletedChild Mental DisorderMoldova, Republic of, North Macedonia, Romania
-
University of KlagenfurtCardiff University; Medical University of Vienna; Bielefeld University; Institute... and other collaboratorsCompletedParent-Child Relations | Family Functioning | Adolescent - Emotional Problem | Well-Being, PsychologicalNorth Macedonia
-
University of Cape TownParenting for Lifelong Health; Mikhulu Trust; Clowns Without Borders South Africa and other collaboratorsNot yet recruitingChild MaltreatmentZimbabwe
-
University of North Carolina, Chapel HillNot yet recruitingAdolescent BehaviorUnited States
-
University of ManitobaUniversity of Calgary; Tactica Interactive; Centre for Healthcare Innovation; Research...Unknown