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 | ✓ | ✓ | |||||
a-NFPP: adapted New Forest Parenting Programme; CSRI-R: Revised Client Service Receipt Inventory; CSS, Current Symptoms Scale; DISC-IV, Diagnostic Interview Schedule for Children Version 4; EASI, Emotionality, Activity, Sociability and Impulsivity; EE, expressed emotion; ECBI, Eyberg Child Behaviour Inventory; EQ-5D, EuroQol - 5 Dimensions; FMSS, five-minute speech sample; FSI, Family Strain Index; GHQ, General Health Questionnaire; GIPCI, Global Impressions of Parent–child Interactions; IY, Incredible Years; ODD, oppositional defiant disorder; PARI, Preschool ADHD Risk Index; PIP, Parenting Intervention Project; SNAP-IV-P, Swanson, Nolan and Pelham Version 4 parent version; SNAP-IV-T, Swanson, Nolan and Pelham Version 4 teacher version; TAU, treatment as usual; WAI-S, Working Alliance Inventory, Short Form; WWP, Werry-Weiss-Peters Activity Rating Scale.