An interventional study of Parents Taking Action in Development Delay, Neurodevelopmental Disorders and Autism, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-10.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Treatment
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.
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 36 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
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Exclusion Criteria:
A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders for 12 weeks.
Behavioral: Parents Taking Action
A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders.
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.
Time frame: Pre-intervention and post-intervention at 12 weeks
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.
Time frame: Pre-intervention and post-intervention at 12 weeks
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.
Time frame: Pre-intervention and post-intervention at 12 weeks
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.
Time frame: Weekly through intervention (12 weeks total)
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.
Time frame: Pre-intervention and post-intervention at 12 weeks
We recruited participants whose child was waitlisted for an autism or developmental evaluation. 36 participants consented to participate in the single-arm study, but 17 of them did not receive the intervention because they did not complete baseline measures (n=12) or did not begin the intervention (n=5). Thus, 19 people began the intervention. Of these, 15 completed the intervention and all data points; the remaining 4 only completed part of the intervention and did not complete all data points.
| Milestone | Parents Taking Action |
|---|---|
| Started | 19 |
| Completed | 15 |
| Not completed | 4 |
| Withdrew: Did not complete intervention | 4 |
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.
| score on a scale | Parents Taking Action |
|---|---|
| Pre-intervention | 14.4 ± 11.4 |
| Post-intervention | 12.2 ± 8.52 |
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.
| score on a scale | Parents Taking Action |
|---|---|
| Pre-intervention | 15.2 ± 9.7 |
| Post-intervention | 10.6 ± 8.35 |
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.
| score on a scale | Parents Taking Action |
|---|---|
| Pre-intervention | 85.5 ± 12.3 |
| Post-intervention | 99.7 ± 14.4 |
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.
| score on a scale | Parents Taking Action |
|---|---|
| Fidelity | 98 ± .04 |
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.
| score on a scale | Parents Taking Action |
|---|---|
| Pre-intervention (positive social behavior total score) | 11.0 ± 4.4 |
| Post-intervention (positive social behavior total score) | 12.1 ± 5.5 |
| Pre-intervention (problem behavior total score) | 45.3 ± 32.6 |
| Post-intervention (problem behavior total score) | 37.5 ± 19.7 |
Collected over We collected data on all participants while they were enrolled in the study, which lasted through completion of baseline data until post-intervention data collection (approximately 12 weeks). This single-arm was minimal risk and only involved participants engaging in a psychoeducational parenting program. In order to reduce risks and promote participant safety, we developed a Safety Plan for any emergencies or distress, as well as a Resource List for any parents seeking additional support.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Parents Taking Action | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
19 people began the intervention; however, only 15 completed the intervention. The results here are based on 15 participants.
| Age, Continuous(years) | Parents Taking Action |
|---|---|
| Mean | 37.3 ± 11.2 |
| Sex: Female, Male(Participants) | Parents Taking Action |
|---|---|
| Female | 14 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | Parents Taking Action |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 15 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Employment Status(Participants) | Parents Taking Action |
|---|---|
| Employed full-time | 5 |
| Employed part-time | 4 |
| Self-employed | 4 |
| Unemployed | 2 |
| Marital Status(Participants) | Parents Taking Action |
|---|---|
| Never married | 8 |
| Married | 5 |
| Divorced | 1 |
| Other | 1 |
| Education Level(Participants) | Parents Taking Action |
|---|---|
| High school graduate | 9 |
| College graduate | 3 |
| Graduate/professional school | 3 |
| Annual Household Income (USD)(Participants) | Parents Taking Action |
|---|---|
| <$10,000 | 5 |
| $10,000 - $29,999 | 3 |
| $30,000 - $49,999 | 3 |
| $50,000 - $69,999 | 1 |
| ≥$70,000 | 1 |
| Don't know/not sure | 2 |
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University of Maryland, Baltimore