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IRCT20220219054063N1 IRCT 2022-04-29 University of social welfare and rehabilitation sciences Development of enhanced milieu teaching, parent-implemented and telepractice and investigating its effectiveness on speech and language toddlers with cleft palate. Development of Enhanced Milieu Teaching with Phonological Emphasis, Telepractice and Parent-Implemented Protocol and Investigating Its Effectiveness on Speech and Language Development of Persian Toddlers with Cleft Lip and /or Palate. 2022-06-14 anticipated 32 Complete https://irct.ir/trial/62059 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: After primary assessment, the number of vocabulary and consonants inventory will be determined for each participant. then each participant is allocated into two intervention groups of I) EMT+PE or II) conventional interventions(consultative interventions) that in each age group randomization will be made for block random clinical trials by blockrand package in R 4.1.3 software. it is noted that randomization is performed according to age groups and intervention groups (i.e 32 participants were assigned in 2 intervention groups based on 3 age groups). N/A Cleft palate with cleft lip. Intervention 1: Intervention group: speech and language assessment outcomes of each child will be analyzed in experimental intervention group and intervention plans will be set for each child individually according to child speech and language assessment outcomes. The parents who will participate in experimental intervention of EMT+PE, will be educated through supportive speech and language strategies by educated therapists . This education will be based on educational protocol of TMCR. Each therapist is responsible for educating at least 5 parents will participate in the intervention group. Supportive Speech and language strategies separately saves on the USB drive and they are given to the parents. Strategies are selected from primary to advanced according to the level of child speech and language. During the intervention course, the interaction between parent-child will be repeated at home 2 times per week for 3 months (24 sessions) at least 20 minutes each time. In the first month, in each week maximum 2 Supportive speech and language strategies of EMT+PE are educated to the experimental intervention group by educational videos, online and offline sessions in WhatsApp (Teach and model). Then, parents will provide a video from interaction of themselves with child and the application of educated strategies and will send it to the relevant therapist. The therapist will watch the videos and the strengths and weaknesses are identified and appropriate feedback is given to the parent. (Coach and review). Parents must provide a video from interaction sessions between themselves and child 2 times per week for at least 20 minutes and send it to the therapist. In these videos, educated strategies must be clearly implemented. At the end of third week education of Supportive speech and language strategies will be accomplished. In the Last week, educated strategies will be integrated and parents’ total skill in simultaneously performing of all strategies will be assessed. Also, the last week of month fidelity measurement scale of parents is completed by the therapist. If parents are not qualified enough in different sections, parent education will be repeated. At the beginning of the second month, each week parent must provide 2 videos to show how to use Supportive speech and language strategies in order to interact with child. These videos will be sent to educated therapists and they will be examined according to TMCR. The assessment of intervention outcomes will be accomplished at the end of third month. 2 months is considered for maintenance of intervention outcomes that in this stage parents will not be coached and follow-up will start after 2 weeks since the assessments of end of intervention complete. speech and language assessment will be repeated after 2 months. in each stage of assessment, inter-rater reliability will be accomplished for at least %20 of all transcripted language and articulation samples. If the raters would not reach an acceptable agreement, two other raters will repeat the assessments. Fidelity of implementation will be accomplished in sessions 6,12 and 18 in intervention phase and 5,10, and 15 in follow-up phase. Fidelity of implementation will be accomplished in order to ensure therapists and parents perform the intervention strategies correctly that if the therapists and parents would not get appropriate scores in pre-intervention and intervention respectively, education must be repeated. Intervention 2: Control group: Participants who are randomly assigned in control group, they would not receive experimental intervention of EMT+PE, but they will be underwent conventional interventions in cleft lip and palate teams and private clinics. conventional interventions define as any intervention offers to these children in cleft lip and palate teams and private clinics, except ongoing experimental intervention. Considering that conventional interventions for these children usually offer in the form of speech and language consultations to parents. Assessment steps of pre-intervention and after 3 months intervention will be implemented completely for the control group. 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public University of Social Welfare and Rehabilitation Sciences
University of social welfare and rehabilitation science, Kodakyar Ave., Daneshjo Blvd.,Tehran,Iran
Tehran Iran (Islamic Republic of) 1985713834 +98 21 7644 4705 nedatahmasebist@gmail.com University of social welfare and rehabilitation sciences scientific University of social welfare and rehabilitation sciences
University of social welfare and rehabilitation science, Kodakyar Ave., Daneshjo Blvd.,Evin,Tehran,Iran
Tehran Iran (Islamic Republic of) 1985713834 +98 21 7644 4705 nedatahmasebist@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) All children will meet the following criteria: Persian Iranian children with CL/P between 18 and 36 months of age at pre-intervention. Non-existence a syndrome diagnosis from a geneticist and by referring medical records in cleft lip and palate teams. For children with clefts involving the palate, underwent primary palate repair by 12 months of age. Non-existence a sensorineural hearing loss or sound field hearing threshold over 30 dB HL by referring medical records in cleft lip and palate teams. Pre-intervention assessment of children with typical development by ages and stages questionnaires (ASQ). Child joint attention with the parent during collection of play-based language sample. At least one type of error during the language sample a) a compensatory error on at least one phoneme, b) a consonant inventory of fewer than five stop or nasal consonants in all positions and / or c) errors on at least two stop or nasal consonants. Child Can produce at least 5 different words per parent report on the MCDI. 18 months 3 years Both Children will be bilingual or multilingual or non-Persian speaking on the basis of parent report. In addition to the CL/P, having other dysmorphic features that have effect on speech (such as short frenulum, short hard palate, deep palate, fistula in palate). Q37 Cleft palate with cleft lip Rehabilitation Rehabilitation Intervention group: speech and language assessment outcomes of each child will be analyzed in experimental intervention group and intervention plans will be set for each child individually according to child speech and language assessment outcomes. The parents who will participate in experimental intervention of EMT+PE, will be educated through supportive speech and language strategies by educated therapists . This education will be based on educational protocol of TMCR. Each therapist is responsible for educating at least 5 parents will participate in the intervention group. Supportive Speech and language strategies separately saves on the USB drive and they are given to the parents. Strategies are selected from primary to advanced according to the level of child speech and language. During the intervention course, the interaction between parent-child will be repeated at home 2 times per week for 3 months (24 sessions) at least 20 minutes each time. In the first month, in each week maximum 2 Supportive speech and language strategies of EMT+PE are educated to the experimental intervention group by educational videos, online and offline sessions in WhatsApp (Teach and model). Then, parents will provide a video from interaction of themselves with child and the application of educated strategies and will send it to the relevant therapist. The therapist will watch the videos and the strengths and weaknesses are identified and appropriate feedback is given to the parent. (Coach and review). Parents must provide a video from interaction sessions between themselves and child 2 times per week for at least 20 minutes and send it to the therapist. In these videos, educated strategies must be clearly implemented. At the end of third week education of Supportive speech and language strategies will be accomplished. In the Last week, educated strategies will be integrated and parents’ total skill in simultaneously performing of all strategies will be assessed. Also, the last week of month fidelity measurement scale of parents is completed by the therapist. If parents are not qualified enough in different sections, parent education will be repeated. At the beginning of the second month, each week parent must provide 2 videos to show how to use Supportive speech and language strategies in order to interact with child. These videos will be sent to educated therapists and they will be examined according to TMCR. The assessment of intervention outcomes will be accomplished at the end of third month. 2 months is considered for maintenance of intervention outcomes that in this stage parents will not be coached and follow-up will start after 2 weeks since the assessments of end of intervention complete. speech and language assessment will be repeated after 2 months. in each stage of assessment, inter-rater reliability will be accomplished for at least %20 of all transcripted language and articulation samples. If the raters would not reach an acceptable agreement, two other raters will repeat the assessments. Fidelity of implementation will be accomplished in sessions 6,12 and 18 in intervention phase and 5,10, and 15 in follow-up phase. Fidelity of implementation will be accomplished in order to ensure therapists and parents perform the intervention strategies correctly that if the therapists and parents would not get appropriate scores in pre-intervention and intervention respectively, education must be repeated. Control group: Participants who are randomly assigned in control group, they would not receive experimental intervention of EMT+PE, but they will be underwent conventional interventions in cleft lip and palate teams and private clinics. conventional interventions define as any intervention offers to these children in cleft lip and palate teams and private clinics, except ongoing experimental intervention. Considering that conventional interventions for these children usually offer in the form of speech and language consultations to parents. Assessment steps of pre-intervention and after 3 months intervention will be implemented completely for the control group. Number of production words. Timepoint: Pre-intervention, post-intervention, after follow-up. Method of measurement: CDI. Mean length utterance. Timepoint: Pre-intervention, post-intervention, after follow-up. Method of measurement: Language sample. Number of different words. Timepoint: Pre-intervention, post-intervention, after follow-up. Method of measurement: Language sample. Number of total words. Timepoint: Pre-intervention, post-intervention, after follow-up. Method of measurement: Language sample. Number of consonant inventory. Timepoint: Pre-intervention, post-intervention, after follow-up. Method of measurement: Speech sample. Percent of correct consonants. Timepoint: Pre-intervention, post-intervention, after follow-up. Method of measurement: Speech sample. Intelligibility. Timepoint: Pre-intervention, post-intervention, after follow-up. Method of measurement: ICS. University of social welfare and rehabilitation sciences Approved 2022-02-15 Ethics committee of university of social welfare and rehabilitation sciences University of social welfare and rehabilitation science, Kodakyar Ave., Daneshjo Blvd.,Evin,,Tehran,Iran Tehran Tehran Iran (Islamic Republic of)