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CompletedNCT02852291PMD2Updated Jul 17, 2024

Parents Make the Difference II: Trial of a Parenting Intervention

An interventional study of Parents Make the Difference and Parents Make the Difference Plus in Parenting and Child Abuse, sponsored by Duke University. Completed at 1 site in Liberia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-17.

Sponsored by Duke University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
201
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Parenting
  • Child Abuse
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In context

Lead sponsor

Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • does not live with child
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
201 participants (actual)

Study arms

  • Experimental
    Parents Make the Difference

    Parents Make the Difference (Caregivers attend 10 group parent training sessions)

    Behavioral: Parents Make the Difference

  • 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

  • No intervention
    Waitlist Control

    No parenting intervention until the end of the study period

Interventions

  • BehavioralParents Make the Difference

    10 parent training sessions delivered to groups of caregivers

  • BehavioralParents Make the Difference Plus

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

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What researchers measure

Primary outcomes

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

    Extent to which caregivers engage in harsh discipline practices

    Time frame: 1 month post treatment

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

    Quality of parent-child relationships and interactions

    Time frame: 1 month post treatment

Secondary outcomes

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

    Use of harsh discipline practices, including physical and verbal strategies

    Time frame: 12 months post treatment

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

    Quality of parent-child relationships and interactions

    Time frame: 12 months post treatment

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

    Indicators of child emotional problems and problems in peer relationships

    Time frame: 1 and 12 months post treatment

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

    Frequency of disruptive behaviors / SDQ items related to behavioral problems

    Time frame: 1 and 12 months post treatment

  5. Parental Stress: Parental Stress Scale

    Level of caregiver parenting-related stress

    Time frame: 1 and 12 months post treatment

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

    Locally relevant indicators of parental knowledge about child development

    Time frame: 1 and 12 months post treatment

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

    Indicators of quality of marital interactions, including relationship violence

    Time frame: 1 and 12 months post treatment

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

    Indicators of caregiver mental health symptoms

    Time frame: 1 and 12 months post treatment

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

    Basic indicators of hand washing behavior and resources

    Time frame: 1 and 12 months post treatment

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

    Child verbal abilities (brief assessment)

    Time frame: 1 and 12 months post treatment

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Study locations

1 site
  • International Rescue Committee
    Monrovia, Liberia
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References and documents

Individual participant data

Plan to share: Yes — following anonymization and publication

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02852291
Lead sponsor
Duke University
Collaborators
International Rescue Committee
Responsible party
Sponsor
First posted
Aug 2, 2016
Start date
Mar 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jul 17, 2024

Study contacts

Eve Puffer, PhD
principal investigator · Duke University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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