18 and older, any sex, with Development Delay or Neurodevelopmental Disorders. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Parenting StressPrimary· 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
Group
Value
95% CI
Parents Taking Action
14.4
± 11.4
Post-intervention
Group
Value
95% CI
Parents Taking Action
12.2
± 8.52
DepressionSecondary· 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
Group
Value
95% CI
Parents Taking Action
15.2
± 9.7
Post-intervention
Group
Value
95% CI
Parents Taking Action
10.6
± 8.35
Family FunctioningSecondary· 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
Group
Value
95% CI
Parents Taking Action
85.5
± 12.3
Post-intervention
Group
Value
95% CI
Parents Taking Action
99.7
± 14.4
FidelitySecondary· 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.
Group
Value
95% CI
Parents Taking Action
98
± .04
Child BehaviorSecondary· 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 (positive social behavior total score)
Group
Value
95% CI
Parents Taking Action
11.0
± 4.4
Post-intervention (positive social behavior total score)
Group
Value
95% CI
Parents Taking Action
12.1
± 5.5
Pre-intervention (problem behavior total score)
Group
Value
95% CI
Parents Taking Action
45.3
± 32.6
Post-intervention (problem behavior total score)
Group
Value
95% CI
Parents Taking Action
37.5
± 19.7
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Maryland, Baltimore
Last refreshed: 10 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04313283.