Mental Health IssueNCT04627792
Improving Child Mental Health Service Utilization in Ibadan
A study testing IUSECAMH Parent Intervention (Waitlist) in people with Mental Health Issue, run by Howard University.
Trial summary
The investigators will develop and evaluate a community-based participatory intervention that will be principally guided by the model we test and confirm in Aim 1. To meet this second aim, ten guardian consultants will co-develop and co-implement a group intervention whose goal is to increase 100 guardians'… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- IUSECAMH Parent Intervention (Waitlist)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Apr 2022
- 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
- Participated in Phase 1 of student (participated in structured interview)
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
Olayinka Omigbodun contact
About this study
Official title: Improving Child Mental Health Service Utilization in Ibadan Nigeria Using a Community Based Participatory Research Approach
The investigators will develop and evaluate a community-based participatory intervention that will be principally guided by the model we test and confirm in Aim 1. To meet this second aim, ten guardian consultants will co-develop and co-implement a group intervention whose goal is to increase 100 guardians' recognition and knowledge of CAMH problems, perceived need for CAMH services, and willingness to use accessible services at UCH. The investigators will also evaluate the process of developing, planning, and administering a CBP intervention in Nigeria and draw broader implications for CBP programming in other LMICs.
Read the detailed description
One hundred participants will be randomly recruited from the cohort of guardians who completed the interview in Phase 1 and expressed interest in participating in an intervention. The investigators will use a switching replication design in which fifty guardians will be randomly assigned using a lottery to receive the intervention and fifty will be assigned to a group who will receive the intervention at a later time point.127 The latter group will serve as a control in the first part of the intervention plan, and the roles will be switched in the second part. The investigators will initially propose 4 intervention sessions, each comprised of 2 meetings, lasting 1.5 hours each for 25 guardians. Two sessions will be conducted concurrently for Group 1 (n=50) followed by 2 sessions concurrently conducted for Group 2 (n=50). The program outcomes - guardian recognition and knowledge of CAMH problems, the perceived need for CAMH services, and willingness to use accessible CAMH services - will be measured with the same instruments administered in Aim 1
- Conditions
- Mental Health Issue
- Being tested
- IUSECAMH Parent Intervention (Waitlist)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUSECAMH Parent Intervention (Waitlist)Behavioural
We will use a switching replication design in which fifty guardians will be randomly assigned using a lottery to receive the intervention and fifty will be assigned to a group who will receive the intervention at a later time point
| Study group | Role | What they receive |
|---|---|---|
| Waitlist Group | Other | We will use a switching replication design in which fifty guardians will be randomly assigned using a lottery to receive the intervention and fifty will be assigned to a group who will receive the intervention at a later time point Receives: Behavioral: IUSECAMH Parent Intervention (Waitlist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guardian recognition and knowledge of CAMH problems
This was assessed by the Yorùbá version of the Strengths and Difficulties Questionnaire - Parent Report (SDQ-P; Goodman, Ford, Simmons; Gatward, \& Meltzer, 2000), a 25-item screening measure of emotional and behavioral problems for children aged 3 to 17-years extensively used in Africa (Hoosen et al., 2018). The SDQ-P utilized a three-point Likert scale (0=not true; 1=somewhat true; 2= certainly true). Five subscales were derived from the measure including conduct problems, inattention-hyperactivity, emotional symptoms, peer problems, and prosocial behavior. A total score was calculated by summing the subscales with higher scores indicating more recognition of CAMH problems (range= 0 - 50).
Measured: up to 2 months
Perceived need for CAMH services
Adapted from the 2001 National Survey of Children with Special Health Care Needs in the United States (Porterfield \& McBride, 2007), we asked caregivers: "Has there been a time in past year when your child/ any of your children (1) seemed sad and did not feel like doing anything over 2 weeks (yes/no)?; (2) not able to sit still or concentrate for long, always getting into trouble (yes/no)?; (3) displayed strange public behavior such as talking or laughing to themselves when no one is around (yes/no)?; (4) behaved in any way or reported feeling anyway that worried them, you, or others in your family or community?" If caregivers affirmed any of the 4 statements, they were subsequently asked: "During the past 12 months, was there any time when your child needed help because you were worried about the problems you just described? (yes/no)" Responses to the final question (0=no; 1=yes) was used to determine perceived need of CAMH services.
Measured: up to 2 months
Willingness to use accessible CAMH services
Caregivers' willingness to use accessible mental health service was adapted from a study examining child mental health service utilization among parents in rural Appalachia (S. L. Williams \& Polaha, 2014). Caregivers were asked "If my child experienced a mental health condition such as Dapo, Tola, and Moji [fictional characters with depression, ADHD, and psychosis in a previously administered section], I would take my child to see a healthcare provider at the mental health clinic for children and adolescents at UCH" (1 = Not at All, 6=Definitely).
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Howard University
- Sponsor type
- University, hospital or other
- Collaborators
- University College Hospital, Ibadan
- Responsible party
- Sponsor
- Investigators
- Ezer Kang, Principal investigator, Howard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627792
- Sponsor's protocol ID
- 9414
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Child Mental Health Service Utilization in Ibadan Nigeria Using a Community Based Participatory Research Approach
- ClinicalTrials.gov ID
- NCT04627792
- Acronym / sponsor ID
- 9414
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Howard UniversityUniversity, hospital or other
- Collaborators
- University College Hospital, Ibadan
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 13 Nov 2020 (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.
The investigators will develop and evaluate a community-based participatory intervention that will be principally guided by the model we test and confirm in Aim 1. To meet this second aim, ten guardian consultants will co-develop and co-implement a group intervention whose goal is to increase 100 guardians' recognition and knowledge of CAMH problems, perceived need for CAMH services, and willingness to use accessible services at UCH. The investigators will also evaluate the process of developing, planning, and administering a CBP intervention in Nigeria and draw broader implications for CBP programming in other LMICs.
Detailed description
One hundred participants will be randomly recruited from the cohort of guardians who completed the interview in Phase 1 and expressed interest in participating in an intervention. The investigators will use a switching replication design in which fifty guardians will be randomly assigned using a lottery to receive the intervention and fifty will be assigned to a group who will receive the intervention at a later time point.127 The latter group will serve as a control in the first part of the intervention plan, and the roles will be switched in the second part. The investigators will initially propose 4 intervention sessions, each comprised of 2 meetings, lasting 1.5 hours each for 25 guardians. Two sessions will be conducted concurrently for Group 1 (n=50) followed by 2 sessions concurrently conducted for Group 2 (n=50). The program outcomes - guardian recognition and knowledge of CAMH problems, the perceived need for CAMH services, and willingness to use accessible CAMH services - will be measured with the same instruments administered in Aim 1
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Waitlist Group | Other | Behavioral: IUSECAMH Parent Intervention (Waitlist)We will use a switching replication design in which fifty guardians will be randomly assigned using a lottery to receive the intervention and fifty will be assigned to a group who will receive the intervention at a later time point |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participated in Phase 1 of student (participated in structured interview)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| IUSECAMH Parent Intervention (Waitlist)We will use a switching replication design in which fifty guardians will be randomly assigned using a lottery to receive the intervention and fifty will be assigned to a group who will receive the intervention at a later time point | Behavioural | Waitlist Group |
Primary outcome
Guardian recognition and knowledge of CAMH problems
Time frame: up to 2 months
This was assessed by the Yorùbá version of the Strengths and Difficulties Questionnaire - Parent Report (SDQ-P; Goodman, Ford, Simmons; Gatward, \& Meltzer, 2000), a 25-item screening measure of emotional and behavioral problems for children aged 3 to 17-years extensively used in Africa (Hoosen et al., 2018). The SDQ-P utilized a three-point Likert scale (0=not true; 1=somewhat true; 2= certainly true). Five subscales were derived from the measure including conduct problems, inattention-hyperactivity, emotional symptoms, peer problems, and prosocial behavior. A total score was calculated by summing the subscales with higher scores indicating more recognition of CAMH problems (range= 0 - 50).
Perceived need for CAMH services
Time frame: up to 2 months
Adapted from the 2001 National Survey of Children with Special Health Care Needs in the United States (Porterfield \& McBride, 2007), we asked caregivers: "Has there been a time in past year when your child/ any of your children (1) seemed sad and did not feel like doing anything over 2 weeks (yes/no)?; (2) not able to sit still or concentrate for long, always getting into trouble (yes/no)?; (3) displayed strange public behavior such as talking or laughing to themselves when no one is around (yes/no)?; (4) behaved in any way or reported feeling anyway that worried them, you, or others in your family or community?" If caregivers affirmed any of the 4 statements, they were subsequently asked: "During the past 12 months, was there any time when your child needed help because you were worried about the problems you just described? (yes/no)" Responses to the final question (0=no; 1=yes) was used to determine perceived need of CAMH services.
Willingness to use accessible CAMH services
Time frame: up to 2 months
Caregivers' willingness to use accessible mental health service was adapted from a study examining child mental health service utilization among parents in rural Appalachia (S. L. Williams \& Polaha, 2014). Caregivers were asked "If my child experienced a mental health condition such as Dapo, Tola, and Moji [fictional characters with depression, ADHD, and psychosis in a previously administered section], I would take my child to see a healthcare provider at the mental health clinic for children and adolescents at UCH" (1 = Not at All, 6=Definitely).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- 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.
Olayinka Omigbodun contact
Ezer Kang principal investigator
Howard University
Questions about this trial
What is this clinical trial studying?
A study testing IUSECAMH Parent Intervention (Waitlist) in people with Mental Health Issue, run by Howard University.
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: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ezer Kang, PhD (202-806-6844, ezer.kang@howard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Guardian recognition and knowledge of CAMH problems (time frame: up to 2 months). The study lists 3 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 13 Nov 2020.