Rebecca E Waugh, Laura D Fredrick, Paul A Alberto
Using simultaneous prompting to teach sounds and blending skills to students with moderate intellectual disabilities
Research in developmental disabilities
covid19 related lockdowns distancing measures presented families unprecedented challenges ukwide cohort study tracking changes families mental health since early lockdown cospace found significant rise primary schoolaged childrens behaviour problems associated familyrelated stress threequarters parents cospace also reported wanting extra support sparkle examine whether providing cospace families smartphone application delivering information parenting support parent positive reverse negative effects pandemic children parents efficacy child parent outcomes costeffectiveness parent positive examined also test whether effects moderated preexisting levels child conduct problems usage parent positive exploratory analyses examine whether baseline characteristics lockdown circumstances moderate effects parent positive sparkle twoarm superiority parallel group randomised controlled trial embedded existing large ukwide selfselected community cohort cospace consent sparkle randomised 11 either parent positive followup usual fau cospace ukwide longitudinal cohort study parents aged 18 children aged 410 years eligible sparkle parent positive digital public health intervention delivered rapidly scale support parents managing childrens behaviour reduce conduct problems levels family conflict exacerbated first lockdown may increase future months families need cope continuous uncertainty disruption daily lives codesigned parents based decades parenting research parent positive consists three elements parenting boosters advice delivered form narrated animations videos graphics text provided help parents eight common parenting challenges ii parenting exchange facilitated parenttoparent communication peer support platform iii parent resources giving access carefully selected highquality evidencebased online parenting resources followup usual fau selected comparator public health nature meant active comparator appropriate due pragmatic rapid implementation trial individuals randomised fau receive intervention first two months data baseline t1 t2 t3 collected given full access app 30th november 2021 outcome measures collected remotely qualtrics according cospace schedule baseline t1 cospace survey data obtained immediately prior randomisation one month t2 two months t3 postrandomisation measures collected assess group differences child parent outcomes costs service utilisation adverse events usage parent positive also tracked primary outcome parentreported child conduct problems onemonth postrandomisation measured using strengths difficulties questionnaire conduct problems subscale enrolled participants allocated parent positive fau ratio 11 simple randomisation using randomizer function within qualtrics programme neither blocking stratification used possible blind parents enrolled study qualtrics automatically inform parents group allocation blinded members research team senior statistician given access qualtrics system data order remain blinded analysis complete anticipate serious harms associated taking part intervention therefore need unblind blinded staff study junior statistician unblinded throughout total 616 recruited trial 308 consenting parents randomised treatment arm v10 15032021 yet recruiting anticipated start date 1st april 2021 anticipated end date recruitment 31st july 2021 clinicaltrialgov nct04786080 trial prospectively registered 8 march 2021 full protocol attached additional file accessible trials website additional file 1 interest expediting dissemination material familiar formatting eliminated letter serves summary key elements full protocol study protocol reported accordance standard protocol items recommendations clinical interventional trials spirit guidelines additional file 2