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Trial record 5 of 20 for:    Liberia

Parents Make the Difference II: Trial of a Parenting Intervention

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ClinicalTrials.gov Identifier: NCT02852291
Recruitment Status : Unknown
Verified October 2017 by Duke University.
Recruitment status was:  Active, not recruiting
First Posted : August 2, 2016
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
International Rescue Committee
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parenting Child Abuse Behavioral: Parents Make the Difference Behavioral: Parents Make the Difference Plus Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 816 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Study Start Date : March 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Parenting

Arm Intervention/treatment
Experimental: Parents Make the Difference
Parents Make the Difference (Caregivers attend 10 group parent training sessions)
Behavioral: Parents Make the Difference
10 parent training sessions delivered to groups of caregivers

Experimental: Parents Make the Difference Plus
Parents Make the Difference Plus (Caregivers attend 10 group parent training sessions and receive 3 home visits)
Behavioral: Parents Make the Difference Plus
10 parent training sessions delivered to groups of caregivers, with 3 home visits

No Intervention: Waitlist Control
No parenting intervention until the end of the study period



Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852291


Locations
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Liberia
International Rescue Committee
Monrovia, Liberia
Sponsors and Collaborators
Duke University
International Rescue Committee
Investigators
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Principal Investigator: Eve Puffer, PhD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02852291     History of Changes
Other Study ID Numbers: pmd2
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: following anonymization and publication