Parenting BehaviorNCT01829815
Impact of a Parenting Program in Liberia to Improve Parenting, Education, and Health Outcomes for Children in Liberia
A study testing Parents Make the Difference in people with Parenting Behavior and Pre-academic and Developmental Skills, run by International Rescue Committee at 1 site in Liberia.
Trial summary
The aim of this study is to assess the impact of an intervention to improve parenting practices, pre-academic and developmental skills, and use of mosquito nets for children in kindergarten in Liberia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting Behavior, Pre-academic and Developmental Skills, Malaria Prevention
- What is being tested?
- Parents Make the Difference
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteLiberia
- Study dates
- Aug 2012to Mar 2013
- 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
- Parents or primary caregivers (age 18 or above) of children ages 3-7 enrolled in kindergarten
- Resident in one of five study sites
Who cannot join
- Severe cognitive disability of caregiver affecting ability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact Evaluation of a Parenting Program to Improve Parenting, Education, and Health Outcomes for Young Children in Liberia
The aim of this study is to assess the impact of an intervention to improve parenting practices, pre-academic and developmental skills, and use of mosquito nets for children in kindergarten in Liberia. A rigorous impact evaluation using a randomized, waitlist controlled design will be conducted to measure the impact of the intervention on three primary outcomes: positive parenting skills, children's cognitive and educational skills, and malaria knowledge and prevention behaviors.
- Being tested
- Parents Make the Difference
- Keywords
- Child, Parents, Parenting, Child Development, Parent Child Relations, Malaria, Primary Prevention, Punishment, Education
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parents Make the DifferenceBehavioural
The intervention, entitled "Parents Make the Difference," will include 10 sessions. Parents will attend in a group, and sessions will include didactic information, guided discussion, and modeling and practice of new skills. All sessions focus on positive parenting skills, with specific skills across three domains that have strong links to child outcomes: (a) positive, non-physical behavior management strategies, (b) strategies for promoting children's early learning, and (c) strategies, primarily use of bed nets, for preventing malaria in children.
| Study group | Role | What they receive |
|---|---|---|
| "Parents Make the Difference" | Experimental | Caregivers are enrolled in the 10-session Parents Make the Difference intervention. Receives: Behavioral: Parents Make the Difference |
| Waitlist Control | Other | Caregivers assigned to the control group received the 10-session Parents Make the Difference intervention after the study was completed. Receives: Behavioral: Parents Make the Difference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Behavior Assessment (adapted from multiple scales for this context)
This is a caregiver-report survey measures including items on various parenting practices, including: caregiver-child communication; discipline and behavior management practices; caregiver-child affection and shared activities; caregiver involvement in child's school and educational activities. These items will yield several subscores for these different domains. Some items may also be analyzed as single items, as they measure specific and important outcomes (e.g., use of a harsh discipline strategy)
Measured: 1 month
Parenting Self-Efficacy and Beliefs Assessment (adapted from other scales for this context; includes unique items developed for this context)
These items assess parents' confidence in their parenting abilities and their beliefs about caregiving practices. This measure will yield separate scores for self-efficacy and beliefs about caregiving practices. Some items may also be analyzed as single items, as they measure specific and important outcomes (e.g., parents' belief about an aspect of harsh discipline)
Measured: 1 month
Child Behavior Assessment (items adapted from the Strengths and Difficulties Questionnaire)
This tool assess children's behaviors and emotional well-being in the domains of hyperactivity, anger, aggression, mood, and peer relationships. They will be analyzed as an overall score, and single items may be analyzed for certain behaviors or indicators of emotional well-being.
Measured: 1 month
Parent-Child Interaction Observation
Caregivers and children in the study will be asked to engage in a play interaction for five minutes, and their verbal interactions will be audio-recorded. Recordings will be coded for specific behaviors. The coding system is adapted from the Dyadic Parent Child Interaction Coding System.
Measured: 1 month
Child Cognitive / Pre-Academic Abilities and Emotional Well-being
Children will be administered activity-based items to assess a range of cognitive and learning skills, including verbal and language skills (as measured by several activities), numeracy, and pattern recognition. Items will be combined into composite scores but may also be analyzed separately to measure outcomes on specific abilities (e.g., counting). Children will also be asked five questions related to their emotional well-being adapted from the Strengths and Difficulties Questionnaire. These items will be analyzed as a sum score, and individual items may be analyzed for specific indicators of emotional well-being.
Measured: 1 month
Secondary outcomes (1)
Mosquito net usage
A survey will be used to assess mosquito net usage by household members. Items will be analyzed separately to assess discrete behaviors (e.g., whether child him/herself slept under the net; whether any adult(s) slept under the net)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startAug 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parenting BehaviorStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Rescue Committee
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Eve Puffer, PhD, Principal investigator, Duke UniversityRhea Chase, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829815
- Sponsor's protocol ID
- 5108
- Status last verified
- Jan 2016
- First submitted
- 8 Apr 2013
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: File needs to be anonymized
Publications
Puffer ES, Green EP, Chase RM, Sim AL, Zayzay J, Friis E, Garcia-Rolland E, Boone L. Parents make the difference: a randomized-controlled trial of a parenting intervention in Liberia. Glob Ment Health (Camb). 2015 Aug 4;2:e15. doi: 10.1017/gmh.2015.12. eCollection 2015.
PubMed 28596863Annan J, Sim A, Puffer ES, Salhi C, Betancourt TS. Improving Mental Health Outcomes of Burmese Migrant and Displaced Children in Thailand: a Community-Based Randomized Controlled Trial of a Parenting and Family Skills Intervention. Prev Sci. 2017 Oct;18(7):793-803. doi: 10.1007/s11121-016-0728-2.
PubMed 27858282
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of a Parenting Program to Improve Parenting, Education, and Health Outcomes for Young Children in Liberia
- ClinicalTrials.gov ID
- NCT01829815
- Acronym / sponsor ID
- 5108
- Keywords
- Child, Parents, Parenting, Child Development, Parent Child Relations, Malaria, Primary Prevention, Punishment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- International Rescue CommitteeUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- Aug 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Apr 2013 (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.
The aim of this study is to assess the impact of an intervention to improve parenting practices, pre-academic and developmental skills, and use of mosquito nets for children in kindergarten in Liberia. A rigorous impact evaluation using a randomized, waitlist controlled design will be conducted to measure the impact of the intervention on three primary outcomes: positive parenting skills, children's cognitive and educational skills, and malaria knowledge and prevention behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Parents Make the Difference" | Experimental | Behavioral: Parents Make the DifferenceCaregivers are enrolled in the 10-session Parents Make the Difference intervention. |
| Waitlist Control | Other | Behavioral: Parents Make the DifferenceCaregivers assigned to the control group received the 10-session Parents Make the Difference intervention after the study was completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parents or primary caregivers (age 18 or above) of children ages 3-7 enrolled in kindergarten
- Resident in one of five study sites
Key exclusion criteria (1 listed)
- Severe cognitive disability of caregiver affecting ability to provide informed consent
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 DifferenceThe intervention, entitled "Parents Make the Difference," will include 10 sessions. Parents will attend in a group, and sessions will include didactic information, guided discussion, and modeling and practice of new skills. All sessions focus on positive parenting skills, with specific skills across three domains that have strong links to child outcomes: (a) positive, non-physical behavior management strategies, (b) strategies for promoting children's early learning, and (c) strategies, primarily use of bed nets, for preventing malaria in children. | Behavioural | "Parents Make the Difference", Waitlist Control |
Primary outcome
Parenting Behavior Assessment (adapted from multiple scales for this context)
Time frame: 1 month
This is a caregiver-report survey measures including items on various parenting practices, including: caregiver-child communication; discipline and behavior management practices; caregiver-child affection and shared activities; caregiver involvement in child's school and educational activities. These items will yield several subscores for these different domains. Some items may also be analyzed as single items, as they measure specific and important outcomes (e.g., use of a harsh discipline strategy)
Parenting Self-Efficacy and Beliefs Assessment (adapted from other scales for this context; includes unique items developed for this context)
Time frame: 1 month
These items assess parents' confidence in their parenting abilities and their beliefs about caregiving practices. This measure will yield separate scores for self-efficacy and beliefs about caregiving practices. Some items may also be analyzed as single items, as they measure specific and important outcomes (e.g., parents' belief about an aspect of harsh discipline)
Child Behavior Assessment (items adapted from the Strengths and Difficulties Questionnaire)
Time frame: 1 month
This tool assess children's behaviors and emotional well-being in the domains of hyperactivity, anger, aggression, mood, and peer relationships. They will be analyzed as an overall score, and single items may be analyzed for certain behaviors or indicators of emotional well-being.
Parent-Child Interaction Observation
Time frame: 1 month
Caregivers and children in the study will be asked to engage in a play interaction for five minutes, and their verbal interactions will be audio-recorded. Recordings will be coded for specific behaviors. The coding system is adapted from the Dyadic Parent Child Interaction Coding System.
Child Cognitive / Pre-Academic Abilities and Emotional Well-being
Time frame: 1 month
Children will be administered activity-based items to assess a range of cognitive and learning skills, including verbal and language skills (as measured by several activities), numeracy, and pattern recognition. Items will be combined into composite scores but may also be analyzed separately to measure outcomes on specific abilities (e.g., counting). Children will also be asked five questions related to their emotional well-being adapted from the Strengths and Difficulties Questionnaire. These items will be analyzed as a sum score, and individual items may be analyzed for specific indicators of emotional well-being.
1 secondary outcome
Mosquito net usage
Time frame: 1 month
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 25 Jan 2016.
- Derived from this study: PubMed 28596863Puffer ES, Green EP, Chase RM, Sim AL, Zayzay J, Friis E, Garcia-Rolland E, Boone L. Parents make the difference: a randomized-controlled trial of a parenting intervention in Liberia. Glob Ment Health (Camb). 2015 Aug 4;2:e15. doi: 10.1017/gmh.2015.12. eCollection 2015.
- Derived from this study: PubMed 27858282Annan J, Sim A, Puffer ES, Salhi C, Betancourt TS. Improving Mental Health Outcomes of Burmese Migrant and Displaced Children in Thailand: a Community-Based Randomized Controlled Trial of a Parenting and Family Skills Intervention. Prev Sci. 2017 Oct;18(7):793-803. doi: 10.1007/s11121-016-0728-2.
- Individual participant dataSharing planned: Undecided. File needs to be anonymized
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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
Rhea Chase, 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 in people with Parenting Behavior and Pre-academic and Developmental Skills, run by International Rescue Committee 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 2 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 25 Jan 2016. 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?
Parenting Behavior Assessment (adapted from multiple scales for this context) (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01829815, which also lists 2 linked publications.
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 25 Jan 2016.