NCT04627792

Brief 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' 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

November 2, 2020

Last Update Submit

November 6, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

    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.

    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).

    up to 2 months

Study Arms (1)

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

Behavioral: IUSECAMH Parent Intervention (Waitlist)

Interventions

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

Waitlist Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participated in Phase 1 of student (participated in structured interview)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Waiting Lists

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Ezer Kang

    Howard University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olayinka Omigbodun

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 13, 2020

Study Start

December 1, 2020

Primary Completion

August 1, 2021

Study Completion

April 1, 2022

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share