- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04313283
Translating Peer-to-Peer Support Into a Clinical Setting
Addressing Racial Disparities in Autism Diagnosis and Treatment: Translating Peer-to-Peer Support Into a Clinical Setting
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Partners at the University of Maryland Baltimore (UMB) School of Medicine (SOM), School of Social Work (SSW), and community collaborators will pilot an intervention focused on Black and African-American children with Autism Spectrum Disorder (hereafter, autism) and other developmental delays. The research fills several gaps in the academic literature. First, there is a dearth of intervention research focusing on Black families raising young children with autism. Early intervention significantly improves child and family outcomes across childhood and into adulthood. Yet, Black children with autism are less likely to access such services. Even when controlling for socioeconomic status, racial disparities in autism and developmental disability diagnoses and services persist. The causes for these socioeconomic and racial disparities are largely unknown. Researchers have recommended caregiver support programming while on waitlists to improve caregiver-provider interactions and caregiver knowledge of the diagnostic process; yet, such interventions have not been described in the literature.
SSW researchers led a community-based trial to adapt a peer-led intervention, Parents Taking Action, for low-income Black families raising children with autism in Baltimore. The psychoeducational and child behavior management intervention, led by trained Parent Leaders, is unique in that it considers families' cultural and socioeconomic characteristics. Our social work team worked closely with our community advisory board to make cultural adaptations to the manual for use in Baltimore with a majority Black population. Our social work team has since further adapted the program to deliver content in two six-week modules (12 weeks total).
Despite the social work team's efforts to understand and address racial autism disparities, a wholly community-based model has limitations. Once a child is referred to a clinic for developmental concerns, long appointment waitlists contribute to further delays in timely diagnosis and treatment, as well as parental distress. Wait times also contribute to appointment absenteeism, which further delays timely access to care. A study suggested support programs for waitlisted families can begin to address these challenges. In total, these studies have suggested an integrated community-clinical model can provide critical supports to children and their families while on a waitlist and strengthen connections between families and clinical providers. Thus, this project will test the feasibility, acceptability, and short-term outcomes of a peer-led program, Parents Taking Action with a clinical sample.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Parent or other primary caregiver of a child age eight years or younger on University of Maryland Baltimore, Developmental-Behavioral waiting list for autism or developmental concerns
- Identify self or child as Black or African American.
Exclusion Criteria:
- Parent or other primary caregiver is younger than 18 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Parents Taking Action
A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders for 12 weeks.
|
A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parenting Stress
Time Frame: Pre-intervention and post-intervention at 12 weeks
|
Autism Parenting Stress Index (APSI): This measure includes 13 items that assess core autism symptoms, comorbid behaviors, and comorbid physical behaviors.
Each item is based on a 5-point rating scale with descriptors for 0, 1, 2, 3, and 5. Possible range is 0-65.
Higher scores indicate more parenting stress.
|
Pre-intervention and post-intervention at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: Pre-intervention and post-intervention at 12 weeks
|
Center for Epidemiological Studies-Depression (CES-D)- This measure contains 20 items assess 4 separate factors: depressive affect, somatic symptoms, positive affect, and interpersonal relations.
Each item is based on a 4-point rating scale with descriptors for 0, 1, 2, and 3. Possible range is 0-60.
A score of 16 points or more considered depressed.
|
Pre-intervention and post-intervention at 12 weeks
|
Family Functioning
Time Frame: Pre-intervention and post-intervention at 12 weeks
|
Family Outcomes Survey-Revised (FOS-R): This measure was developed to provide child and family outcomes for evaluation the effectiveness of early intervention program.
This measure includes 24 items assessing five outcomes (1) family needs/strengths (4 items); (2) advocacy (5 items); (3) child learning support (4 items); (4) social support (5 items); and (5) community access (6 items).
Each item is based on a 5-point rating scale with descriptors for 1, 2, 3, 4, and 5. Possible range is 24-120.
Higher scores indicate better family functioning.
|
Pre-intervention and post-intervention at 12 weeks
|
Fidelity
Time Frame: Weekly through intervention (12 weeks total)
|
Procedural Fidelity Checklist Self-Assessment for Promotora Home Visits: This measurement was developed to evaluate Parent Leaders' fidelity on the program delivery.
This measure includes 16 items the Parent Leader completes after every program session.
Each item is based on two responses: (1) I did this; (2) I did not this.
Possible range is 0-100.
Higher scores indicate less fidelity.
|
Weekly through intervention (12 weeks total)
|
Child Behavior
Time Frame: Pre-intervention and post-intervention at 12 weeks
|
Nisonger Child Behavior Rating Form (NCBRF)- This measure includes 76 item in two sections, reported separately: positive social behavior and problem behavior. Each item is based on a 4-point rating scale with descriptors for 0, 1, 2, and 3. Section 1 (positive social behavior) contains 10 items and scores range from 0-30. Higher scores indicate more positive social behavior. Section 2 (problem behavior) contains 66 items and scores range from 0-198. Higher scores indicate more child behavior problems. |
Pre-intervention and post-intervention at 12 weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Magana S, Lopez K, Salkas K, Iland E, Morales MA, Garcia Torres M, Zeng W, Machalicek W. A Randomized Waitlist-Control Group Study of a Culturally Tailored Parent Education Intervention for Latino Parents of Children with ASD. J Autism Dev Disord. 2020 Jan;50(1):250-262. doi: 10.1007/s10803-019-04252-1.
- Kuhn JL, Vanegas SB, Salgado R, Borjas SK, Magana S, Smith DaWalt L. The Cultural Adaptation of a Transition Program for Latino Families of Youth with Autism Spectrum Disorder. Fam Process. 2020 Jun;59(2):477-491. doi: 10.1111/famp.12439. Epub 2019 Mar 7.
- Shaia WE, Nichols HM, Dababnah S, Campion K, Garbarino N. Brief Report: Participation of Black and African-American Families in Autism Research. J Autism Dev Disord. 2020 May;50(5):1841-1846. doi: 10.1007/s10803-019-03926-0.
- Dababnah S, Shaia WE, Campion K, Nichols HM. "We Had to Keep Pushing": Caregivers' Perspectives on Autism Screening and Referral Practices of Black Children in Primary Care. Intellect Dev Disabil. 2018 Oct;56(5):321-336. doi: 10.1352/1934-9556-56.5.321.
- Koegel LK, Koegel RL, Ashbaugh K, Bradshaw J. The importance of early identification and intervention for children with or at risk for autism spectrum disorders. Int J Speech Lang Pathol. 2014 Feb;16(1):50-6. doi: 10.3109/17549507.2013.861511. Epub 2013 Dec 11.
- Feinberg E, Silverstein M, Donahue S, Bliss R. The impact of race on participation in part C early intervention services. J Dev Behav Pediatr. 2011 May;32(4):284-91. doi: 10.1097/DBP.0b013e3182142fbd.
- Nguyen CT, Krakowiak P, Hansen R, Hertz-Picciotto I, Angkustsiri K. Sociodemographic Disparities in Intervention Service Utilization in Families of Children with Autism Spectrum Disorder. J Autism Dev Disord. 2016 Dec;46(12):3729-3738. doi: 10.1007/s10803-016-2913-3.
- Mandell DS, Ittenbach RF, Levy SE, Pinto-Martin JA. Disparities in diagnoses received prior to a diagnosis of autism spectrum disorder. J Autism Dev Disord. 2007 Oct;37(9):1795-802. doi: 10.1007/s10803-006-0314-8. Epub 2006 Dec 8.
- Denman K, Smart C, Dallos R, Levett P. How Families Make Sense of Their Child's Behaviour When on an Autism Assessment and Diagnosis Waiting List. J Autism Dev Disord. 2016 Nov;46(11):3408-3423. doi: 10.1007/s10803-016-2873-7.
- Kalb LG, Freedman B, Foster C, Menon D, Landa R, Kishfy L, Law P. Determinants of appointment absenteeism at an outpatient pediatric autism clinic. J Dev Behav Pediatr. 2012 Nov-Dec;33(9):685-97. doi: 10.1097/DBP.0b013e31826c66ef.
- Connolly M, Gersch I. A support group for parents of children on a waiting list for an assessment for autism spectrum disorder. Educational Psychology in Practice. 2013; 29(3): 293-308.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00090447
- 1UL1TR003098 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neurodevelopmental Disorders
-
University of Missouri-ColumbiaCompletedChildren With Neurodevelopmental DisordersUnited States
-
IRCCS Eugenio MedeaRecruitingNeurodevelopmental Disorder (Diagnosis)Italy
-
NeuroModulation Technique Research InstituteCompletedAutism | Neurodevelopmental DisorderUnited States
-
National Institute of Mental Health (NIMH)RecruitingHealthy Children | Children With Neurodevelopmental Disorders | Children With Neuropsychiatric Disorders | Children With Behavioral SyndromesUnited States
-
University of StrathclydeGöteborg University; University of Aberdeen; University of Glasgow; HarimataUnknownAutism Spectrum Disorder | Other Neurodevelopmental DisorderSweden, United Kingdom
-
Iama Therapeutics S.r.l.Recruiting
-
University of AlbertaAlberta Health servicesRecruitingNeurodevelopmental DisordersCanada
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingNeurodevelopmental Disorders
-
University of North Carolina, Chapel HillNational Center for Advancing Translational Sciences (NCATS); RTI InternationalCompletedNeurodevelopmental DisordersUnited States
-
ProbiSearch SLNot yet recruitingNeurodevelopmental Disorders
Clinical Trials on Parents Taking Action
-
University of Texas at AustinRecruitingDepression | AutismUnited States
-
Chinese University of Hong KongCompletedGastrointestinal Hemorrhage | Melena | Hematemesis | Platelet DysfunctionChina
-
Boston Medical CenterThe Joel and Barbara Alpert Endowment For The Children of The CityCompletedSudden Infant Death | Health EducationUnited States
-
Centre Hospitalier Universitaire de BesanconUnknownThoracic or Abdominal Aortic Aneurysm With no Indication for Surgical TreatmentFrance
-
University of MichiganCompleted
-
National Heart Centre SingaporeSingapore General Hospital; Abbott; Beckman Coulter GmbHCompleted
-
Hadassah Medical OrganizationUnknown
-
Children's Mercy Hospital Kansas CityUniversity of South FloridaCompleted
-
New York UniversityNot yet recruitingChild Sexual AbuseUnited States
-
Southeast University, ChinaNot yet recruiting