Main
|
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: |
|
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
|
Source(s) of Monetary Support
|
Foundation Sunnerdahls Disability Fund, The Queen Silvia Jubilee Fund, Department of Research and Development - Uppsala County Council, Uppsala University
|
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:
|
|
|
|