Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Change from Baseline in Percentage of Child Eye Contact during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks. |
Parent participants will record and submit a five-minute video of themselves using the PRT intervention strategies with their child using the clinical trial's smartphone app. Trained research assistants will behaviorally score each video using computer-based behavioral coding software (Noldus Observer XT) on a continuous basis for the total frequency and duration of child eye contact (i.e. child gazing in the direction of the caregiver's head). The minimum percentage is 0% (no eye contact) and the maximum is 100% (constant eye contact). |
Baseline, 8 weeks (intervention completion), 16 weeks (follow-up) |
|
| Other |
Scale of Treatment Perceptions (Total Score) |
The Scale of Treatment Perceptions (STP; Berger, et al., 2016) assesses parents' satisfaction with intervention using the mean of survey items with 1-7 Likert rating scale, with higher scores indicating higher levels of satisfaction (better outcome). |
8 weeks |
|
| Other |
Parent Adherence to Treatment and Competence Measure |
The PATC is a six-item self-report adherence-to-treatment and competence measure (PATC; Kasari et al., 2010) will be administered to parents once they complete the app program. The measure consists of four items concerning adherence to treatment protocol: (1) made time to carry out the learned strategies, (2) found it complex to carry out the learned strategies, (3) thought it natural to carry out the learned strategies, and (4) made an effort to carry out the learned strategies. The PATC also includes two items concerning parental competence: (1) was confident carrying out the learned strategies, and (2) was comfortable carrying out the learned strategies. All items consist of a series of ratings on a 1-5 Likert rating scale, with higher scores indicating a better outcome. |
8 weeks |
|
| Primary |
Change from Baseline in Parent Fidelity of Implementation of Pivotal Response Treatment (PRT) during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks |
Parent participants will record and submit a five-minute video of themselves using the PRT intervention strategies with their child using the clinical trial's smartphone app. Trained research assistants will behaviorally score each video using computer-based behavioral coding software (Noldus Observer XT) on a trial-by-trial basis for the presence or absence of each PRT intervention component, which include the use of: child choice, child attention, clear opportunities, contingent reinforcement, reinforcement of child response attempts, a balance of maintenance and acquisition tasks, and task variation. Total uses of these components will be divided by total uses + absences of these components to yield a percentage. The mean percentage of all components will be used as the primary outcome, with a range of 0% to 100% use of the PRT components. |
Baseline, 8 weeks (intervention completion), 16 weeks (follow-up) |
|
| Secondary |
Change from Baseline in Frequency of Child Vocalizations/Word Use during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks. |
Parent participants will record and submit a five-minute video of themselves using the PRT intervention strategies with their child using the clinical trial's smartphone app. Trained research assistants will behaviorally score each video using computer-based behavioral coding software (Noldus Observer XT) on a continuous basis for the total frequency of child vocalizations and word use (both prompted and unprompted/spontaneous). The minimum number of vocalizations/words is 0 (no vocalizations or spoken words) and there is technically no maximum (although this is limited by the 5-minute duration of the video probe). |
Baseline, 8 weeks (intervention completion), 16 weeks (follow-up) |
|
| Secondary |
Change from Baseline in Percentage of Child Positive Affect during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks. |
Parent participants will record and submit a five-minute video of themselves using the PRT intervention strategies with their child using the clinical trial's smartphone app. Trained research assistants will behaviorally score each video using computer-based behavioral coding software (Noldus Observer XT) on a continuous basis for the total duration of child positive affect (i.e. directed positive facial expressions - observable smiling and laughter). The minimum percentage is 0% (no positive affect) and the maximum is 100% (constant presence of positive affect). |
Baseline, 8 weeks (intervention completion), 16 weeks (follow-up) |
|
| Secondary |
Change from Baseline in MacArthur-Bates Communicative Development Inventory (CDI), Level I Short Form (Total Score) at 16 weeks |
The MacArthur-Bates CDI (Fenson et al., 2000) is a caregiver-reported measure of child expressive vocabulary use. Parents will complete a digital version of the CDI to obtain information on reported word usage and understanding. |
Baseline, 16 weeks (follow-up) |
|
| Secondary |
Change from Baseline in Vineland Adaptive Behavior Scales, Third Edition (Standard Score on Communication Domain) at 16 weeks |
The Vineland-III (Sparrow et al., 2016) is a caregiver-completed measure of adaptive functioning in children. Parents will complete a digital version of the Communication Domain of the Vineland-III Parent/Caregiver Rating Form. Item responses are converted to Standard Scores with a mean of 100 and a Standard Deviation of 15. |
Baseline, 16 weeks (follow-up) |
|
| Secondary |
Change from Baseline in Vineland Adaptive Behavior Scales, Third Edition (Standard Score on Socialization Domain) at 16 weeks |
The Vineland-III (Sparrow et al., 2016) is a caregiver-completed measure of adaptive functioning in children. Parents will complete a digital version of the Socialization Domain of the Vineland-III Parent/Caregiver Rating Form. Item responses are converted to Standard Scores with a mean of 100 and a Standard Deviation of 15. |
Baseline, 16 weeks (follow-up) |
|
| Secondary |
Change from Baseline in Social Responsiveness Scale, Second Edition (SRS-2; Total T-Score) at 16 weeks |
The SRS-2 (Constantino & Gruber, 2007) is a caregiver-completed measure of a child's autism symptom severity. Parents will complete a digital version of the Toddler SRS-2. Item responses are converted to a SRS-2 T-score with a mean of 50 and a Standard Deviation of 10. |
Baseline, 16 weeks (follow-up) |
|
