Trial Outcomes & Findings for Translating Peer-to-Peer Support Into a Clinical Setting (NCT NCT04313283)
NCT ID: NCT04313283
Last Updated: 2023-03-10
Results Overview
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.
COMPLETED
NA
36 participants
Pre-intervention and post-intervention at 12 weeks
2023-03-10
Participant Flow
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.
Participant milestones
| Measure |
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.
Parents Taking Action: A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders.
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|---|---|
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Overall Study
STARTED
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19
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|
Overall Study
COMPLETED
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15
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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.
Parents Taking Action: A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders.
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|---|---|
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Overall Study
did not complete intervention
|
4
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Baseline Characteristics
Translating Peer-to-Peer Support Into a Clinical Setting
Baseline characteristics by cohort
| Measure |
Parents Taking Action
n=15 Participants
A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders for 12 weeks.
Parents Taking Action: A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders.
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|---|---|
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Age, Continuous
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37.3 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Employment Status
Employed full-time
|
5 Participants
n=5 Participants
|
|
Employment Status
Employed part-time
|
4 Participants
n=5 Participants
|
|
Employment Status
Self-employed
|
4 Participants
n=5 Participants
|
|
Employment Status
Unemployed
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2 Participants
n=5 Participants
|
|
Marital Status
Never married
|
8 Participants
n=5 Participants
|
|
Marital Status
Married
|
5 Participants
n=5 Participants
|
|
Marital Status
Divorced
|
1 Participants
n=5 Participants
|
|
Marital Status
Other
|
1 Participants
n=5 Participants
|
|
Education Level
High school graduate
|
9 Participants
n=5 Participants
|
|
Education Level
College graduate
|
3 Participants
n=5 Participants
|
|
Education Level
Graduate/professional school
|
3 Participants
n=5 Participants
|
|
Annual Household Income (USD)
<$10,000
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5 Participants
n=5 Participants
|
|
Annual Household Income (USD)
$10,000 - $29,999
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3 Participants
n=5 Participants
|
|
Annual Household Income (USD)
$30,000 - $49,999
|
3 Participants
n=5 Participants
|
|
Annual Household Income (USD)
$50,000 - $69,999
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1 Participants
n=5 Participants
|
|
Annual Household Income (USD)
≥$70,000
|
1 Participants
n=5 Participants
|
|
Annual Household Income (USD)
Don't know/not sure
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2 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Pre-intervention and post-intervention at 12 weeksAutism 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.
Outcome measures
| Measure |
Parents Taking Action
n=15 Participants
A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders for 12 weeks.
Parents Taking Action: A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders.
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|---|---|
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Parenting Stress
Pre-intervention
|
14.4 score on a scale
Standard Deviation 11.4
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|
Parenting Stress
Post-intervention
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12.2 score on a scale
Standard Deviation 8.52
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SECONDARY outcome
Timeframe: Pre-intervention and post-intervention at 12 weeksCenter 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.
Outcome measures
| Measure |
Parents Taking Action
n=15 Participants
A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders for 12 weeks.
Parents Taking Action: A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders.
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|---|---|
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Depression
Pre-intervention
|
15.2 score on a scale
Standard Deviation 9.7
|
|
Depression
Post-intervention
|
10.6 score on a scale
Standard Deviation 8.35
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SECONDARY outcome
Timeframe: Pre-intervention and post-intervention at 12 weeksFamily 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.
Outcome measures
| Measure |
Parents Taking Action
n=15 Participants
A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders for 12 weeks.
Parents Taking Action: A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders.
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|---|---|
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Family Functioning
Pre-intervention
|
85.5 score on a scale
Standard Deviation 12.3
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Family Functioning
Post-intervention
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99.7 score on a scale
Standard Deviation 14.4
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SECONDARY outcome
Timeframe: Weekly through intervention (12 weeks total)Population: Parent Leaders report fidelity 0-100 on each session they have with intervention participants.
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.
Outcome measures
| Measure |
Parents Taking Action
n=183 intervention sessions
A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders for 12 weeks.
Parents Taking Action: A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders.
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|---|---|
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Fidelity
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98 score on a scale
Standard Deviation .04
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SECONDARY outcome
Timeframe: Pre-intervention and post-intervention at 12 weeksNisonger 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.
Outcome measures
| Measure |
Parents Taking Action
n=15 Participants
A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders for 12 weeks.
Parents Taking Action: A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders.
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|---|---|
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Child Behavior
Pre-intervention (positive social behavior total score)
|
11.0 score on a scale
Standard Deviation 4.4
|
|
Child Behavior
Post-intervention (positive social behavior total score)
|
12.1 score on a scale
Standard Deviation 5.5
|
|
Child Behavior
Pre-intervention (problem behavior total score)
|
45.3 score on a scale
Standard Deviation 32.6
|
|
Child Behavior
Post-intervention (problem behavior total score)
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37.5 score on a scale
Standard Deviation 19.7
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Adverse Events
Parents Taking Action
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place