Table 3.
Schedule of enrollment, interventions, and assessments.
| Time point | T0a | T1b | IIc | T2d | EIe | T3f | ||||||||||||||
| Enrollment | ||||||||||||||||||||
|
|
Eligibility screening | ✓ |
|
|
|
|
|
|||||||||||||
|
|
Informed consent | ✓ |
|
|
|
|
|
|||||||||||||
|
|
Allocation | ✓ |
|
|
|
|
|
|||||||||||||
| Interventions | ||||||||||||||||||||
|
|
Index intervention group sessions |
|
|
✓ |
|
✓ |
|
|||||||||||||
|
|
Active control group sessions |
|
|
✓ |
|
✓ |
|
|||||||||||||
|
|
Passive control group sessions |
|
|
|
|
|
|
|||||||||||||
| Quantitative assessments | ||||||||||||||||||||
|
|
Primary outcomes | |||||||||||||||||||
|
|
|
Child language |
|
✓ |
|
✓ |
|
✓ | ||||||||||||
|
|
|
Parental sensitivity and parent-child reciprocity |
|
✓ |
|
✓ |
|
✓ | ||||||||||||
|
|
Secondary outcomes | |||||||||||||||||||
|
|
|
Child attention |
|
✓ |
|
✓ |
|
✓ | ||||||||||||
|
|
|
Child behavior |
|
✓ |
|
✓ |
|
✓ | ||||||||||||
|
|
|
Parenting |
|
✓ |
|
✓ |
|
✓ | ||||||||||||
|
|
|
Parental stress |
|
✓ |
|
✓ |
|
✓ | ||||||||||||
|
|
Exploratory outcomes | |||||||||||||||||||
|
|
|
Child health |
|
✓ |
|
✓ |
|
✓ | ||||||||||||
|
|
Moderators and selected confounding variables | |||||||||||||||||||
|
|
|
Sex of the child | ✓ |
|
|
|
|
|
||||||||||||
|
|
|
Socioeconomic situation | ✓ |
|
|
|
|
|
||||||||||||
|
|
|
Cognitive abilities of the caregiver |
|
✓ |
|
|
|
|
||||||||||||
|
|
Qualitative assessments | |||||||||||||||||||
|
|
|
Interviews with caregivers |
|
✓ |
|
✓ |
|
✓ | ||||||||||||
|
|
|
Focus groups with caregivers |
|
|
|
✓ |
|
|
||||||||||||
|
|
|
Focus groups with DBSg and PAh facilitators |
|
|
|
✓ |
|
|
||||||||||||
aT0: allocation and enrollment.
bT1: baseline.
cII: intensive intervention.
dT2: post–intensive intervention assessment.
eEI: extensive intervention.
fT3: post–extensive intervention assessment.
gDBS: dialogic book-sharing.
hPA: playful activity.