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Development DelayNCT04313283

Translating Peer-to-Peer Support Into a Clinical Setting

A study testing Parents Taking Action in people with Development Delay and Neurodevelopmental Disorders, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is not a lot of research focusing on Black and African American families raising young children with developmental delays. While the investigators know that early intervention helps children and their families, Black children with developmental delays are less likely to access such services. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Parents Taking Action
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
16 Sep 2020to 31 Oct 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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.

Who cannot join

  • Parent or other primary caregiver is younger than 18 years old

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Maryland

    Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Addressing Racial Disparities in Autism Diagnosis and Treatment: Translating Peer-to-Peer Support Into a Clinical Setting

There is not a lot of research focusing on Black and African American families raising young children with developmental delays. While the investigators know that early intervention helps children and their families, Black children with developmental delays are less likely to access such services. The causes for these 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 and developmental delays. 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. Support programs for waitlisted families can begin to address these challenges. In this study, the investigators will examine a program called Parents Taking Action with families on a waitlist for a specialty developmental evaluation. The investigators will study if the program is feasible in this setting, if participants like the program, and if child and parent outcomes improve after participants have completed the program.

Read the 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.

Being tested
Parents Taking Action
Keywords
Developmental delays, Parenting, Autism
Medical subject headings
Learning Disabilities, Neurodevelopmental Disorders, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parents Taking ActionBehavioural

    A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders.

Study groups in NCT04313283
Study groupRoleWhat they receive
Parents Taking ActionExperimentalA peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders for 12 weeks.
Receives: Behavioral: Parents Taking Action

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parenting Stress

    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.

    Measured: Pre-intervention and post-intervention at 12 weeks

Secondary outcomes (4)
  1. Depression

    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.

    Measured: Pre-intervention and post-intervention at 12 weeks

  2. Family Functioning

    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.

    Measured: Pre-intervention and post-intervention at 12 weeks

  3. Fidelity

    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.

    Measured: Weekly through intervention (12 weeks total)

  4. Child Behavior

    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.

    Measured: Pre-intervention and post-intervention at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2020
  2. Study start16 Sep 2020
  3. Primary completion31 Oct 2021
  4. Study completion31 Oct 2021

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04313283
Sponsor's protocol ID
HP-00090447
Other IDs
1UL1TR003098
Status last verified
Mar 2023
First submitted
15 Mar 2020
Last updated
10 Mar 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 31606887
  • 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.

    PubMed 30844083
  • 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.

    PubMed 30805765
  • 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.

    PubMed 30273522
  • 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.

    PubMed 24328352
  • 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.

    PubMed 21389865
  • 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.

    PubMed 27639855
  • 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.

    PubMed 17160456
  • 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.

    PubMed 27480420
  • 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.

    PubMed 23095496
  • 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.

  • Reyes C, Dababnah S, Southerland D, Adere A, Shaia WE, Badawi D. Collaborative Program to Support Parents of Black Children Awaiting a Developmental Evaluation. Pediatrics. 2024 Jan 1;153(2):e2023062712. doi: 10.1542/peds.2023-062712. No abstract available.

    PubMed 38192232
  • Dababnah S, Reyes C, Kim I, Badawi DG, Chung Y, Shaia WE. Pilot Trial of a Peer-to-Peer Psychoeducational Intervention for Parents of Black Children Awaiting a Developmental Evaluation. J Dev Behav Pediatr. 2023 Jun-Jul 01;44(5):e370-e378. doi: 10.1097/DBP.0000000000001182. Epub 2023 Apr 26.

    PubMed 37099652

Questions about this trial

What is this clinical trial studying?

A study testing Parents Taking Action in people with Development Delay and Neurodevelopmental Disorders, run by University of Maryland, Baltimore at 1 site in United States.

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 2 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 10 Mar 2023. 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 United States. 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?

Yes. Results are posted in the registry (first posted 10 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Parenting Stress (time frame: Pre-intervention and post-intervention at 12 weeks). 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 NCT04313283, which also lists 13 linked publications.

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 10 Mar 2023.

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