Child DevelopmentNCT03612505
Caregiver Interventions for Developmental Delays in Young Kenyan Children
A study testing Mother groups using principles of UNICEF/World Health Organization's Care for Child Development in people with Child Development and Parenting, run by Indiana University at 1 site in Kenya.
Trial summary
In this study, the investigators will only administer the intervention to children known to have neurodevelopmental delays. By focusing on adapting the intervention to be only a clinic-based treatment, a small number of community members could be trained to administer the program and increase the potential for… Read more about this study
- Who is it for?
- Ages 18 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Parenting, Cognitive Developmental Delay
- What is being tested?
- Mother groups using principles of UNICEF/World Health Organization's Care for Child Development
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteKenya
- Study dates
- 13 Jul 2018to 30 Sep 2019
- 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 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 18-24 months
- communicate in either English or Kiswahili
- Score < 85 on one of the BSID-III subscales (mild/moderate/severe delay in cognitive, motor, or language).
- Have a caregiver who can communicate in English or Kiswahili
- Have a caregiver responsible for child's daily activities
Who cannot join
- Profound neurological impairment, such as severe cerebral palsy, deafness, or blindness preventing them from participating in the groups.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the investigators will only administer the intervention to children known to have neurodevelopmental delays. By focusing on adapting the intervention to be only a clinic-based treatment, a small number of community members could be trained to administer the program and increase the potential for sustainability. If the clinic-based group sessions prove to be effective for young children with neurodevelopmental delays, this would help inform the key areas of fidelity needed to maintain effectiveness of the intervention. This study is a critical first step to evaluating the Care for Child Development Intervention (CCDI) program's potential as a cross-cultural intervention that is sustainable and effective for the children at highest risk for neurodevelopmental delay. These results will have significant impacts in improving early childhood neurodevelopment both in Kenya and worldwide.
Read the detailed description
Objectives:
The broad objective of this proposal is to pilot the CCDI program as an intervention to treat neurodevelopmental delays among 56 young children in Kenya
Specific Aims:
Aim 1: Determine the feasibility of a randomized controlled trial protocol to examine the effectiveness of the CCDI Program for Kenyan children with neurodevelopmental delays aged 18-24 months within a public Maternal-Child Health (MCH) clinic setting.
Hypothesis: The CCDI Program will be feasible, as measured by ≥90% of participants being willing to be randomized to either the intervention or the control group; ≥ 80% attending all 10 biweekly caregiver meetings; ≥80% of children returning for their 6 month follow-up; and ≥80% returning for 12 month follow-up.
Aim 2: Determine the acceptability, facilitators, and barriers of the CCDI Program for use in eligible children.
Hypothesis: The CCDI Program will be acceptable, as determined by an analysis of prospective, concurrent, and retrospective acceptability, and specific facilitators and barriers to the program will be identified. Using focus group discussions and semi-structured interviews with caregivers, clinical providers, and community leaders, the investigators will determine aspects of the program are acceptable, facilitators, and barriers to improved neurodevelopmental care and allow the CCDI program to function optimally in this setting.
Aim 3: Estimate the effect size of the CCDI Program to reduce neurodevelopmental delays in young Kenyan children.
Hypothesis: The investigators will demonstrate a 40% decrease in the number of children with neurodevelopmental delays, as determined by a culturally adapted Bayley Scales of Infant and Toddler Development, 3rd edition (BSID-III) standardized score with implementation of the CCDI Program. This data will inform sample size justification for a future intervention study.
- Conditions
- Child Development, Parenting, Cognitive Developmental Delay
- Being tested
- Mother groups using principles of UNICEF/World Health Organization's Care for Child Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother groups using principles of UNICEF/World Health Organization's Care for Child DevelopmentBehavioural
The intervention is expected to occur every two weeks for a total of ten sessions. On the study day, the child- caregiver dyads randomised to intervention group will be shown to the study room. Each intervention session will be estimated to last 90 minutes allocated as follows: 6
- Introduction (10 minutes)
- Lesson on *Early Childhood Development* topic (20 minutes)
- Discussions on strengthens in caregiving around this topic and areas for improvement (30 minutes)
- Observe caretakers one-on-one in play role with the child (25 minutes)
- Wrap up/Re-cap (5 minutes) Early Childhood development topics that will be covered include per session are: i) Importance of early childhood development ii) Showing love and building trust iii) Awareness of child's well-being iv) Consistency and daily routines v) Discipline and correction vi) consistency and daily routines vii) Nutrition and cleanliness Viii) Importance of play iX) Dealing with life stresses X) Planning for the future
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Not described Receives: Behavioral: Mother groups using principles of UNICEF/World Health Organization's Care for Child Development |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bayley Scales of Infant and Toddler Development, 3rd edition (BSID-III) scores
Measures cognitive, language, and motor development. Composite scores for cognitive (range of scores 55-145), language (range of scores 47-153), and motor (range of scores 46-154) development. Lower scores indicate worse development. Subscales (e.g. fine and gross motor for motor and expressive and receptive language for language) are summed to create the composite score.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (6)
Change In Perspectives around Child Development, gathered by Focus Group Discussions
Qualitative interviews with caregivers in Group 1, who will receive the intervention during the first 6 months of the study. Qualitative interviews will also be performed with Group 2 to see if there were any changes in perspectives on child development without the intervention
Measured: Baseline and 6 months
Change In Perspectives around Child Development, gathered by Focus Group Discussions
Qualitative interviews with caregivers in Group 2, who will receive the intervention during the second 6 months of the study. Qualitative interviews will also be performed with Group 1 to see if there were any changes in perspectives on child development after the intervention has ceased
Measured: 6 months and 12 months
Change in mother interactions, gathered by video-taped mother interactions
Coding of mother's interactions with children while waiting. We will compare Group 1, who will receive the intervention during the first 6 months, as well as Group 2, who will not be receiving the intervention during this interval
Measured: Baseline and 6 months
Change in mother interactions, gathered by video-taped mother interactions
Coding of mother's interactions with children while waiting. We will compare Group 2, who will receive the intervention during the first 6 months, as well as Group 1, who had received the intervention but not longer is receiving it in the second 6 months.
Measured: 6 months and 12 months
Change in Home Observations Measurement of the Environment (HOME) scores
Structured observations and questions performed in a families home. Subscales are as follows: Responsivity (score range 0-11), acceptance (0-8), organization (0-6), learning materials (0-9), involvement (0-6), variety (0-5). The lower scores indicate worse performance. These subscales are summed to give the total score.
Measured: Baseline, 6 months, 12 months
Change in MacArthur-Bates Communication Developmental Inventory (CDI) scores
Language. Scale range is 0-100, with the lower scores indicating worse performance. No subscales will be used in this study.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start13 Jul 2018
- Primary completion14 Feb 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Song McHenry, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612505
- Sponsor's protocol ID
- 1801879405
- Status last verified
- Jun 2024
- First submitted
- 27 Jul 2018
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I'm happy to share the data but I'm not sure of the best means of doing this
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Interventions for Developmental Delays in Young Kenyan Children
- ClinicalTrials.gov ID
- NCT03612505
- Acronym / sponsor ID
- 1801879405
- Conditions
- Child Development, Parenting, Cognitive Developmental Delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 2 Aug 2018 (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.
In this study, the investigators will only administer the intervention to children known to have neurodevelopmental delays. By focusing on adapting the intervention to be only a clinic-based treatment, a small number of community members could be trained to administer the program and increase the potential for sustainability. If the clinic-based group sessions prove to be effective for young children with neurodevelopmental delays, this would help inform the key areas of fidelity needed to maintain effectiveness of the intervention. This study is a critical first step to evaluating the Care for Child Development Intervention (CCDI) program's potential as a cross-cultural intervention that is sustainable and effective for the children at highest risk for neurodevelopmental delay. These results will have significant impacts in improving early childhood neurodevelopment both in Kenya and worldwide.
Detailed description
Objectives:
The broad objective of this proposal is to pilot the CCDI program as an intervention to treat neurodevelopmental delays among 56 young children in Kenya
Specific Aims:
Aim 1: Determine the feasibility of a randomized controlled trial protocol to examine the effectiveness of the CCDI Program for Kenyan children with neurodevelopmental delays aged 18-24 months within a public Maternal-Child Health (MCH) clinic setting.
Hypothesis: The CCDI Program will be feasible, as measured by ≥90% of participants being willing to be randomized to either the intervention or the control group; ≥ 80% attending all 10 biweekly caregiver meetings; ≥80% of children returning for their 6 month follow-up; and ≥80% returning for 12 month follow-up.
Aim 2: Determine the acceptability, facilitators, and barriers of the CCDI Program for use in eligible children.
Hypothesis: The CCDI Program will be acceptable, as determined by an analysis of prospective, concurrent, and retrospective acceptability, and specific facilitators and barriers to the program will be identified. Using focus group discussions and semi-structured interviews with caregivers, clinical providers, and community leaders, the investigators will determine aspects of the program are acceptable, facilitators, and barriers to improved neurodevelopmental care and allow the CCDI program to function optimally in this setting.
Aim 3: Estimate the effect size of the CCDI Program to reduce neurodevelopmental delays in young Kenyan children.
Hypothesis: The investigators will demonstrate a 40% decrease in the number of children with neurodevelopmental delays, as determined by a culturally adapted Bayley Scales of Infant and Toddler Development, 3rd edition (BSID-III) standardized score with implementation of the CCDI Program. This data will inform sample size justification for a future intervention study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Mother groups using principles of UNICEF/World Health Organization's Care for Child Development |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age 18-24 months
- communicate in either English or Kiswahili
- Score < 85 on one of the BSID-III subscales (mild/moderate/severe delay in cognitive, motor, or language).
- Have a caregiver who can communicate in English or Kiswahili
- Have a caregiver responsible for child's daily activities
Key exclusion criteria (1 listed)
- Profound neurological impairment, such as severe cerebral palsy, deafness, or blindness preventing them from participating in the groups.
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 |
|---|---|---|
| Mother groups using principles of UNICEF/World Health Organization's Care for Child DevelopmentThe intervention is expected to occur every two weeks for a total of ten sessions. On the study day, the child- caregiver dyads randomised to intervention group will be shown to the study room. Each intervention session will be estimated to last 90 minutes allocated as follows: 6 * Introduction (10 minutes) * Lesson on *Early Childhood Development* topic (20 minutes) * Discussions on strengthens in caregiving around this topic and areas for improvement (30 minutes) * Observe caretakers one-on-one in play role with the child (25 minutes) * Wrap up/Re-cap (5 minutes) Early Childhood development topics that will be covered include per session are: i) Importance of early childhood development ii) Showing love and building trust iii) Awareness of child's well-being iv) Consistency and daily routines v) Discipline and correction vi) consistency and daily routines vii) Nutrition and cleanliness Viii) Importance of play iX) Dealing with life stresses X) Planning for the future | Behavioural | Intervention |
Primary outcome
Change in Bayley Scales of Infant and Toddler Development, 3rd edition (BSID-III) scores
Time frame: Baseline, 6 months, 12 months
Measures cognitive, language, and motor development. Composite scores for cognitive (range of scores 55-145), language (range of scores 47-153), and motor (range of scores 46-154) development. Lower scores indicate worse development. Subscales (e.g. fine and gross motor for motor and expressive and receptive language for language) are summed to create the composite score.
6 secondary outcomes
Change In Perspectives around Child Development, gathered by Focus Group Discussions
Time frame: Baseline and 6 months
Change In Perspectives around Child Development, gathered by Focus Group Discussions
Time frame: 6 months and 12 months
Change in mother interactions, gathered by video-taped mother interactions
Time frame: Baseline and 6 months
Change in mother interactions, gathered by video-taped mother interactions
Time frame: 6 months and 12 months
Change in Home Observations Measurement of the Environment (HOME) scores
Time frame: Baseline, 6 months, 12 months
Change in MacArthur-Bates Communication Developmental Inventory (CDI) scores
Time frame: Baseline, 6 months, 12 months
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 18 Jun 2024.
- Individual participant dataSharing planned: Undecided. I'm happy to share the data but I'm not sure of the best means of doing this
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mother groups using principles of UNICEF/World Health Organization's Care for Child Development in people with Child Development and Parenting, run by Indiana University at 1 site in Kenya.
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 5 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 18 Jun 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 Kenya. 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?
Change in Bayley Scales of Infant and Toddler Development, 3rd edition (BSID-III) scores (time frame: Baseline, 6 months, 12 months). 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 18 Jun 2024.