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Completed

NCT Number: NCT02852291

Parents Make the Difference II: Trial of a Parenting Intervention

Multisite randomized trial of a parenting intervention in Liberia for caregivers of young children. Two main objectives of the "Parents Make the Difference" program are to teach parents (a) skills for decreasing harsh punishments and replacing those with positive ways to manage children's behavior and (b) skills for having more positive interactions with their children, including interactions that encourage learning. As a result of positive changes in parenting, the investigators expect that, over time, children's behavioral and cognitive well-being will improve and that future abuse and poor developmental outcomes will be prevented in the long-term.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Rescue Committee

Monrovia, Liberia

About this study

This is a multisite randomized trial of a parenting intervention in Liberia for caregivers of young children. The "Parents Make the Difference" program is designed to teach parents (a) skills for decreasing harsh punishments and replacing those with positive ways to manage children's behavior and (b) skills for having more positive interactions with their children. As a result of positive changes in parenting, the investigators expect that, over time, children's behavioral and cognitive well-being will improve and that the intervention will prevent future abuse and poor developmental outcomes in the long-term. This study will randomize 816 caregivers of children ages 3 or 4 years to 1 of 3 study arms: standard group program, group program plus home visits, waitlist control.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • caregiver of child ages 3 or 4
  • live within catchment area of each study site
  • caregiver is at least 18 years old

Exclusion criteria

  • does not live with child

Treatment and study plan

Parents Make the Difference

Behavioral

10 parent training sessions delivered to groups of caregivers

Parents Make the Difference Plus

Behavioral

10 parent training sessions delivered to groups of caregivers, with 3 home visits

Primary outcomes

  1. Caregiver use of harsh discipline practices; assessed using Discipline Interview, Locally-derived items

    Time frame: 1 month post treatment

    Extent to which caregivers engage in harsh discipline practices

  2. Parent-Child Interactions (Parental Acceptance-Rejection Questionnaire; Locally-derived items assessing positive interactions)

    Time frame: 1 month post treatment

    Quality of parent-child relationships and interactions

Secondary outcomes

  1. Caregiver use of harsh discipline practices; assessed using Discipline Interview, Locally-derived items

    Time frame: 12 months post treatment

    Use of harsh discipline practices, including physical and verbal strategies

  2. Parent-Child Interactions (Parental Acceptance-Rejection Questionnaire; Locally-derived items assessing positive interactions)

    Time frame: 12 months post treatment

    Quality of parent-child relationships and interactions

  3. Child social-emotional development and functioning: Ages and Stages Questionnaire; Strengths and Difficulties Questionnaire: emotion problems and peer problems subscales

    Time frame: 1 and 12 months post treatment

    Indicators of child emotional problems and problems in peer relationships

  4. Child behavior: Locally-derived measure of disruptive/non-compliant behaviors; Strengths and Difficulties Questionnaire (conduct problems subscale)

    Time frame: 1 and 12 months post treatment

    Frequency of disruptive behaviors / SDQ items related to behavioral problems

  5. Parental Stress: Parental Stress Scale

    Time frame: 1 and 12 months post treatment

    Level of caregiver parenting-related stress

  6. Parental knowledge of child development: Locally-derived scale

    Time frame: 1 and 12 months post treatment

    Locally relevant indicators of parental knowledge about child development

  7. Marital relationship quality: selected items from Conflict Tactics Scale and locally-derived scale of marital relationship quality

    Time frame: 1 and 12 months post treatment

    Indicators of quality of marital interactions, including relationship violence

  8. Caregiver mental health: General Health Questionnaire (subscale A), Patient Health Questionnaire-9

    Time frame: 1 and 12 months post treatment

    Indicators of caregiver mental health symptoms

  9. Handwashing Behavior Indicators (e.g., access to hand washing station)

    Time frame: 1 and 12 months post treatment

    Basic indicators of hand washing behavior and resources

  10. Child cognitive skills (verbal ability); assessed with a story comprehension task and instruction-following task

    Time frame: 1 and 12 months post treatment

    Child verbal abilities (brief assessment)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • International Rescue Committee

Registry information

Official study title

Parents Make the Difference II: A Randomized Experiment of a Parent Training Program for Caregivers of Young Children Designed to Reduce the Use of Harsh Punishment and Improve Child-caregiver Relationships

Acronym: PMD2

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 2, 2016
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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