Behavior, ChildNCT04697134
Community-Based Conscious Discipline Program in Grenada
A study testing Conscious Discipline-Based Environmental Enrichment Intervention in people with Behavior, Child and Neurocognition, Child, run by Windward Islands Research and Education Foundation at 1 site in Grenada.
Trial summary
To improve neurocognitive outcomes in 2-year-old children by implementing a community-based intervention program that follows the principles of Conscious Discipline. Read more about this study
- Who is it for?
- Ages 22 to 30 monthsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Child, Neurocognition, Child, Development, Child
- What is being tested?
- Conscious Discipline-Based Environmental Enrichment Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 1 siteGrenada
- Study dates
- 2 Feb 2015to 18 Aug 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 22 to 30 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants actively enrolled in the Roving Caregiver Program (0-2-year-olds living with parents in at-risk communities served by the RCP)
Who cannot join
- Not enrolled in the Roving Caregiver Program
Trial locations and contacts
1 site in 1 country.
Grenada1 site
Windward Islands Research and Education Foundation
Saint George's
About this study
Official title: A Community-based Conscious Discipline Program to Reduce Corporal Punishment in the Caribbean
To improve neurocognitive outcomes in 2-year-old children by implementing a community-based intervention program that follows the principles of Conscious Discipline.
Read the detailed description
We aimed to introduce Conscious Discipline (CD) in Grenada as a means of improving neurodevelopment in 2-year-old children. The CD intervention promotes improved social-emotional connections between parents/guardians and children that reduces harsh discipline and corporal punishment and provides an ideal environment for the development of higher cognitive functioning (e.g. working memory, inhibition, emotional regulation).
The intervention is implemented by using a distributed local, train-the-trainer model in partnership with the Grenada Roving Caregiver Program, managed by GRENCASE. CD training was provided to 85 existing Roving Caregivers, 70 of whom were certified as Conscious Discipline Paraprofessionals (CDPPs). Certified CDPPs traveled out to communities and villages throughout Grenada, to impart knowledge and skills to new and expecting parents.
Following the intervention, parents who received CD training were assessed in their ability to implement CD skills with their child(ren). Neurocognition was assessed in children post-intervention using the INTERGROWTH 21st Neurodevelopmental Assessment (INTERNDA). Neurocognitive outcomes were compared between the intervention arm and the waitlist control arm of the study.
- Conditions
- Behavior, Child, Neurocognition, Child, Development, Child
- Being tested
- Conscious Discipline-Based Environmental Enrichment Intervention
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conscious Discipline-Based Environmental Enrichment InterventionBehavioural
Conscious Discipline, a social-emotional skills-based learning program that draws on current brain research and fosters enhanced connections between parents and their children.
| Study group | Role | What they receive |
|---|---|---|
| Conscious Discipline Intervention Group | Experimental | Participants in this group received one-on-one Conscious Discipline classes with a Roving Caregiver. These classes consisted of the dissemination of Conscious Discipline Skills and fun songs, games, and activities to foster connections between the infant and caregiver. Both the infant and caregiver received the intervention simultaneously. Receives: Behavioral: Conscious Discipline-Based Environmental Enrichment Intervention |
| Control | No intervention | Participants in this group did not receive the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
INTERGROWTH 21st Neurodevelopment Assessment (INTER-NDA)
The INTER-NDA is a measure of cognition, motor skills (fine and gross motor), language (expressive and receptive), behavior, executive function, attention and social-emotional reactivity for 2-year-olds. The measure is comprised of 30 items scored across a spectrum, with higher scores indicating better outcomes.
Measured: 22-30 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start2 Feb 2015
- Primary completion18 Aug 2016
- Study completion18 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior, ChildStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Windward Islands Research and Education Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, GRENCASE, St. George's University
- Responsible party
- Principal investigator, Dr. Randall Waechter, Windward Islands Research and Education Foundation
- Investigators
- Randall Waechter, PhD, Principal investigator, Windard Islands Research and Education Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697134
- Sponsor's protocol ID
- SGUSavingBrainsI
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 7 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waechter R, Evans R, Fernandes M, Bailey B, Holmes S, Murray T, Isaac R, Punch B, Cudjoe N, Orlando L, Landon B. A Community-based Responsive Caregiving Program Improves Neurodevelopment in Two-year Old Children in a Middle-Income Country, Grenada, West Indies. Psychosoc Interv. 2022 May 13;31(2):97-107. doi: 10.5093/pi2022a6. eCollection 2022 May.
PubMed 37360060
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Conscious Discipline Program to Reduce Corporal Punishment in the Caribbean
- ClinicalTrials.gov ID
- NCT04697134
- Acronym / sponsor ID
- SGUSavingBrainsI
- Conditions
- Behavior, Child, Neurocognition, Child, Development, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Windward Islands Research and Education FoundationUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, GRENCASE, St. George's University
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 18 Aug 2016 (actual)
- Study completion
- 18 Aug 2016 (actual)
- First posted
- 6 Jan 2021 (actual)
- 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.
To improve neurocognitive outcomes in 2-year-old children by implementing a community-based intervention program that follows the principles of Conscious Discipline.
Detailed description
We aimed to introduce Conscious Discipline (CD) in Grenada as a means of improving neurodevelopment in 2-year-old children. The CD intervention promotes improved social-emotional connections between parents/guardians and children that reduces harsh discipline and corporal punishment and provides an ideal environment for the development of higher cognitive functioning (e.g. working memory, inhibition, emotional regulation).
The intervention is implemented by using a distributed local, train-the-trainer model in partnership with the Grenada Roving Caregiver Program, managed by GRENCASE. CD training was provided to 85 existing Roving Caregivers, 70 of whom were certified as Conscious Discipline Paraprofessionals (CDPPs). Certified CDPPs traveled out to communities and villages throughout Grenada, to impart knowledge and skills to new and expecting parents.
Following the intervention, parents who received CD training were assessed in their ability to implement CD skills with their child(ren). Neurocognition was assessed in children post-intervention using the INTERGROWTH 21st Neurodevelopmental Assessment (INTERNDA). Neurocognitive outcomes were compared between the intervention arm and the waitlist control arm of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conscious Discipline Intervention Group | Experimental | Behavioral: Conscious Discipline-Based Environmental Enrichment InterventionParticipants in this group received one-on-one Conscious Discipline classes with a Roving Caregiver. These classes consisted of the dissemination of Conscious Discipline Skills and fun songs, games, and activities to foster connections between the infant and caregiver. Both the infant and caregiver received the intervention simultaneously. |
| Control | No intervention | –Participants in this group did not receive the intervention. |
Who may qualify
- Ages
- 22 to 30 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants actively enrolled in the Roving Caregiver Program (0-2-year-olds living with parents in at-risk communities served by the RCP)
Key exclusion criteria (1 listed)
- Not enrolled in the Roving Caregiver Program
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 |
|---|---|---|
| Conscious Discipline-Based Environmental Enrichment InterventionConscious Discipline, a social-emotional skills-based learning program that draws on current brain research and fosters enhanced connections between parents and their children. | Behavioural | Conscious Discipline Intervention Group |
Primary outcome
INTERGROWTH 21st Neurodevelopment Assessment (INTER-NDA)
Time frame: 22-30 Months
The INTER-NDA is a measure of cognition, motor skills (fine and gross motor), language (expressive and receptive), behavior, executive function, attention and social-emotional reactivity for 2-year-olds. The measure is comprised of 30 items scored across a spectrum, with higher scores indicating better outcomes.
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 7 Jan 2021.
- Derived from this study: PubMed 37360060Waechter R, Evans R, Fernandes M, Bailey B, Holmes S, Murray T, Isaac R, Punch B, Cudjoe N, Orlando L, Landon B. A Community-based Responsive Caregiving Program Improves Neurodevelopment in Two-year Old Children in a Middle-Income Country, Grenada, West Indies. Psychosoc Interv. 2022 May 13;31(2):97-107. doi: 10.5093/pi2022a6. eCollection 2022 May.
- Individual participant dataSharing planned: No
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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.
Randall Waechter, PhD principal investigator
Windard Islands Research and Education Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conscious Discipline-Based Environmental Enrichment Intervention in people with Behavior, Child and Neurocognition, Child, run by Windward Islands Research and Education Foundation at 1 site in Grenada.
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 1 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 7 Jan 2021. 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 Grenada. 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?
INTERGROWTH 21st Neurodevelopment Assessment (INTER-NDA) (time frame: 22-30 Months). 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 NCT04697134, which also lists 1 linked publication.
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 7 Jan 2021.