ParentingPMD2NCT02852291
Parents Make the Difference II: Trial of a Parenting Intervention
A study testing Parents Make the Difference and Parents Make the Difference Plus in people with Parenting and Child Abuse, run by Duke University at 1 site in Liberia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting, Child Abuse
- What is being tested?
- Parents Make the Difference and Parents Make the Difference Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteLiberia
- Study dates
- Mar 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- caregiver of child ages 3 or 4
- live within catchment area of each study site
- caregiver is at least 18 years old
Who cannot join
- does not live with child
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Parenting, Child Abuse
- Being tested
- Parents Make the Difference, Parents Make the Difference Plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parents Make the DifferenceBehavioural
10 parent training sessions delivered to groups of caregivers
Parents Make the Difference PlusBehavioural
10 parent training sessions delivered to groups of caregivers, with 3 home visits
| Study group | Role | What they receive |
|---|---|---|
| Parents Make the Difference | Experimental | Parents Make the Difference (Caregivers attend 10 group parent training sessions) Receives: Behavioral: Parents Make the Difference |
| Parents Make the Difference Plus | Experimental | Parents Make the Difference Plus (Caregivers attend 10 group parent training sessions and receive 3 home visits) Receives: Behavioral: Parents Make the Difference Plus |
| Waitlist Control | No intervention | No parenting intervention until the end of the study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver use of harsh discipline practices; assessed using Discipline Interview, Locally-derived items
Extent to which caregivers engage in harsh discipline practices
Measured: 1 month post treatment
Parent-Child Interactions (Parental Acceptance-Rejection Questionnaire; Locally-derived items assessing positive interactions)
Quality of parent-child relationships and interactions
Measured: 1 month post treatment
Secondary outcomes (10)
Caregiver use of harsh discipline practices; assessed using Discipline Interview, Locally-derived items
Use of harsh discipline practices, including physical and verbal strategies
Measured: 12 months post treatment
Parent-Child Interactions (Parental Acceptance-Rejection Questionnaire; Locally-derived items assessing positive interactions)
Quality of parent-child relationships and interactions
Measured: 12 months post treatment
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
Measured: 1 and 12 months post treatment
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
Measured: 1 and 12 months post treatment
Parental Stress: Parental Stress Scale
Level of caregiver parenting-related stress
Measured: 1 and 12 months post treatment
Parental knowledge of child development: Locally-derived scale
Locally relevant indicators of parental knowledge about child development
Measured: 1 and 12 months post treatment
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
Measured: 1 and 12 months post treatment
Caregiver mental health: General Health Questionnaire (subscale A), Patient Health Questionnaire-9
Indicators of caregiver mental health symptoms
Measured: 1 and 12 months post treatment
Handwashing Behavior Indicators (e.g., access to hand washing station)
Basic indicators of hand washing behavior and resources
Measured: 1 and 12 months post treatment
Child cognitive skills (verbal ability); assessed with a story comprehension task and instruction-following task
Child verbal abilities (brief assessment)
Measured: 1 and 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- International Rescue Committee
- Responsible party
- Sponsor
- Investigators
- Eve Puffer, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852291
- Sponsor's protocol ID
- 2017-1111
- Acronym
- PMD2
- Status last verified
- Jul 2024
- First submitted
- 7 Mar 2016
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: following anonymization and publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02852291
- Acronym / sponsor ID
- PMD2 / 2017-1111
- Conditions
- Parenting, Child Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- International Rescue Committee
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parents Make the Difference | Experimental | Behavioral: Parents Make the DifferenceParents Make the Difference (Caregivers attend 10 group parent training sessions) |
| Parents Make the Difference Plus | Experimental | Behavioral: Parents Make the Difference PlusParents Make the Difference Plus (Caregivers attend 10 group parent training sessions and receive 3 home visits) |
| Waitlist Control | No intervention | –No parenting intervention until the end of the study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- caregiver of child ages 3 or 4
- live within catchment area of each study site
- caregiver is at least 18 years old
Key exclusion criteria (1 listed)
- does not live with child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parents Make the Difference10 parent training sessions delivered to groups of caregivers | Behavioural | Parents Make the Difference |
| Parents Make the Difference Plus10 parent training sessions delivered to groups of caregivers, with 3 home visits | Behavioural | Parents Make the Difference Plus |
Primary outcome
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
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
10 secondary outcomes
Caregiver use of harsh discipline practices; assessed using Discipline Interview, Locally-derived items
Time frame: 12 months post treatment
Parent-Child Interactions (Parental Acceptance-Rejection Questionnaire; Locally-derived items assessing positive interactions)
Time frame: 12 months post treatment
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
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
Parental Stress: Parental Stress Scale
Time frame: 1 and 12 months post treatment
Parental knowledge of child development: Locally-derived scale
Time frame: 1 and 12 months post treatment
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
Caregiver mental health: General Health Questionnaire (subscale A), Patient Health Questionnaire-9
Time frame: 1 and 12 months post treatment
Handwashing Behavior Indicators (e.g., access to hand washing station)
Time frame: 1 and 12 months post treatment
Child cognitive skills (verbal ability); assessed with a story comprehension task and instruction-following task
Time frame: 1 and 12 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Yes. following anonymization and publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eve Puffer, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parents Make the Difference and Parents Make the Difference Plus in people with Parenting and Child Abuse, run by Duke University at 1 site in Liberia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Liberia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver use of harsh discipline practices; assessed using Discipline Interview, Locally-derived items (time frame: 1 month post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.