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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 22 February 2021
Main ID:  ISRCTN13330627
Date of registration: 09/08/2016
Prospective Registration: No
Primary sponsor: Uppsala University
Public title: ComAlong Toddler - Parental course to help the child to communicate
Scientific title: ComAlong Toddler - Early identification and randomized control trail of a parental course and guidance in the home environment
Date of first enrolment: 01/09/2015
Target sample size: 900
Recruitment status: Ongoing
URL:  http://isrctn.com/ISRCTN13330627
Study type:  Interventional
Study design:  Single-centre randomised controlled trial (Treatment)  
Phase:  Not Applicable
Countries of recruitment
Sweden
Contacts
Name: Anna    Fäldt
Address:  Uppsala universitet CHAP, Munin 75185 Uppsala Sweden
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
Children:
1. Children aged <30 months
2. Children with communication disorder, identified by the Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist at the child health visit at the age of 18 months and children under 30 months of age referred to speech and language pathologist

Parents:
Parents of children with communication delay.

Exclusion criteria:
1. Children whose parents can not fill in parental forms in Swedish
2. Children who live at too great a distance from the town center of Uppsala where the parental course will be offered


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
1. Developmental delay 2. Language delay/impairment 3. Autism spectrum disorder
Mental and Behavioural Disorders
1. Developmental delay 2. Language delay/impairment 3. Autism spectrum disorder
Intervention(s)

Parents will be randomized to either parental course combined with home visit or home visit alone.?For both groups the intervention starts with a home visit where the child's communication, play and language are assessed. The parents receive individual guidance on how to enhance the child's communication and play.

The "ComAlong-toddler" parental course is delivered as five two-hour sessions in a clinical environment. During these sessions the parents receive information about communication, typical development of communication, ways to enhance communication, how to play with the child and information about augmentative and alternative communication. The parents perform home assignments between the sessions where the methods learned are practiced at home, and are recorded on film. During the course, the recordings are used to give individual feedback and opportunity for peer learning. The course is individualized such that the parents set their own goals for the child's further development.

Six months after the initial home visit, families in both groups receive a follow up home visit which involves an assessment of the child's development.
Primary Outcome(s)

1. The child’s communication and symbolic use is measured using the Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist (ITC) and Behavioral Sample (BS) at baseline (initial home visit) and at 6 months (follow up home visit)
2. The parents’ communicative styles with the child are measured using the Responsive Augmentative and Alternative Communication Style Scale (RAACS) at baseline (initial home visit) and 6 months (follow up home visit)
3. The parental view of the child’s use and understanding of speech is measured using the SCS-18, a Swedish short version of Mac Arthur–Bates Communicative Development Inventories (CDI) at baseline (initial home visit) and 6 months (follow up home visit)
Secondary Outcome(s)

1. Prosocial and difficult behaviours are measured using The Strengths and Difficulties Questionnaire when the child is age three
2. Medical diagnoses are collected using information from the child’s medical records continuously, with the final collection when the child turns six
3. Information about the child’s communication, use of AAC and development is measured through developmental assessments and collected through the child’s medical records continuously, with the final collection when the child turns six
4. The number of health care visits is collected using the child’s medical records continuously, with the end point when the child turns six
Secondary ID(s)
N/A
Source(s) of Monetary Support
Foundation Sunnerdahls Disability Fund, The Queen Silvia Jubilee Fund, Department of Research and Development - Uppsala County Council, Uppsala University
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Regional ethical committee at Uppsala University, 15/04/2015, ref: Dnr. 2015/124
Results
Results available: Yes
Date Posted:
Date Completed: 30/06/2022
URL:
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