Table 1 Enrolment, interventions and assessments
Contact and home visits | Screening or diagnostic interview | Consent and TENALEA allocation | Pretreatment (T1) visit | Induction visit by therapist | Intervention: a-NFPP (home) IY (local hall) | Post-treatment (T2) visit (TAU = end of study) | 6 month follow-up (T3) visit (a-NFPP/IY = end of study) |
|---|---|---|---|---|---|---|---|
Timeline | Week 1 to Week 10 | Week 11 to 12 | Week 13 to 24 | Week 25 to 28 | Week 50 | ||
Enrolment | |||||||
Participant informed consent | ✓ | ✓ | |||||
Eligibility | |||||||
WWP (child hyperactivity); parent-completed scale | ✓ | ||||||
PIP developmental scales; research-fellow-administered scale | ✓ | ||||||
DISC-IV ADHD scale, child; research-fellow-administered interview | ✓ | ||||||
TENALEA allocation | ✓ | ||||||
Interventions | |||||||
Arm A: a-NFPP | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Arm B: IY | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Arm C: TAU | ✓ | ✓ | ✓ | ✓ | |||
Measures | |||||||
Primary outcome | |||||||
SNAP IV-P ADHD scale; parent-completed questionnaire | ✓ | ✓ | ✓ | ||||
Secondary outcomes | ✓ | ✓ | ✓ | ||||
Child’s solo play; observation measure, research-fellow-completed | ✓ | ✓ | ✓ | ||||
SNAP IV-T ADHD scale; teacher-completed questionnaire | ✓ | ✓ | ✓ | ||||
SNAP IV-P and T ODD scale: parent- and teacher-completed questionnaires | ✓ | ✓ | ✓ | ||||
ECBI (ODD measure); parent-completed questionnaire | ✓ | ✓ | ✓ | ||||
CSRI-Revised (economic costs); research-fellow-administered questionnaire | ✓ | ✓ | ✓ | ||||
EQ-5D QOL: Parent and parent proxy; parent-completed questionnaires | ✓ | ✓ | ✓ | ||||
Mediators | |||||||
FMSS (maternal expressed emotion); research-fellow-rated | ✓ | ✓ | ✓ | ||||
GIPCI, child/parent observation measure; research-fellow-rated | ✓ | ✓ | ✓ | ||||
Cookie delay task, child observation measure; research-fellow-rated | ✓ | ✓ | ✓ | ||||
GHQ - maternal; parent-completed questionnaire | ✓ | ✓ | ✓ | ||||
Moderators | |||||||
CSS (parental ADHD); parent-completed questionnaire | ✓ | ||||||
Preschool ADHD Risk Index; research-fellow-scored index | ✓ | ||||||
EASI (child temperament); parent-completed questionnaire | ✓ | ||||||
Demographic questionnaire; parent-completed questionnaire | ✓ | ||||||
Genetic testing (saliva sample); self-collected, parent & child | ✓ | ✓ | |||||
LOT; research-fellow-rated | ✓ | ||||||
WAI-S; parent- and therapist-completed questionnaires | ✓ | ✓ | |||||
FSI; parent- and therapist-rated | ✓ | ✓ | |||||