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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Kuwait
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Parenting for Lifelong Health Program (DAYEM)
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.
Behavioral: Adult nutrition
The control group will receive education on adult nutrition over the same period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ministry of Health, Kuwait

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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