ComAlong Toddler - Parental course to help the child to communicate
| ISRCTN | ISRCTN13330627 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13330627 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/06/2016
- Registration date
- 09/08/2016
- Last edited
- 12/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Communication and language difficulties are often a first sign of developmental disabilities, such as delayed development, autism spectrum disorders (conditions where the sufferer has difficulty communicating and relating to others) and speech/language disorders. It is therefore very important to find ways to identify these children and help them develop their communication skills. Studies have shown that parents can help their children to communicate better. This study examines a program called “ComAlong toddler”, a course designed to help parents to support development of their child’s communication, language and play skills. The aim of this study is to find out whether attending this course can help parents to enhance their child’s communication, language and play.
Who can participate?
Children aged less than 30 months old with a communication difficulties and their parents
What does the study involve?
Parents are randomly allocated to one of two groups. Both groups receive a home visit, in which the child’s communication, play and language skills are assessed. The parents then receive individual advice on how to enhance the child's communication and play. Those in the first group then continue as normal. Those in the second group take part in the "ComAlong-toddler" parental course. This involves taking part in five two-hour sessions, during which parents receive information about normal communication development as well as how to enhance communication and how to play with their children. The parents are asked to complete “ homework” in which they practice the skills learned and record play sessions with the child on film. During the course, the recordings are used to provide individual feedback and help the rest of the parents in the group to learn. Six months later, families in both groups are visited again in order for the child’s communication, play and language skills to be reassessed. When the children are six years old, their medical records are reviewed in order to record any medical conditions and to assess their communication skills.
What are the possible benefits and risks of participating?
Children may benefit from improved communication skills. Parents may benefit by gaining more knowledge and empowerment. There are no notable risks involved with taking part in this study.
Where is the study run from?
The study is run from Uppsala University and takes place in participants homes as well as the Child Health Office in Uppsala (Sweden)
When is the study starting and how long is it expected to run for?
January 2015 to June 2022
Who is funding the study?
1. Foundation Sunnerdahls Disability Fund (Sweden)
2. The Queen Silvia Jubilee Fund (Sweden)
3. Department of Research and Development - Uppsala County Council (Sweden)
4. Uppsala University (Sweden)
Who is the main contact?
Mrs Anna Fäldt
Contact information
Scientific
Uppsala universitet
CHAP, Munin
Uppsala
75185
Sweden
 ORCID ID |
0000-0001-7257-8758 |
|---|
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | ComAlong Toddler - Early identification and randomized control trail of a parental course and guidance in the home environment |
| Study acronym | ComAlong Toddler |
| Study objectives | Post-intervention, the intervention group will report improvement in child communication and language and improved parental use of tools to enhance their child's communication. |
| Ethics approval(s) | Regional ethical committee at Uppsala University, 15/04/2015, ref: Dnr. 2015/124 |
| Health condition(s) or problem(s) studied | 1. Developmental delay 2. Language delay/impairment 3. Autism spectrum disorder |
| Intervention | 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. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/01/2015 |
| Completion date | 30/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 30 Months |
| Sex | Both |
| Target number of participants | 750 children and between 70-150 parents. |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/09/2015 |
| Date of final enrolment | 30/06/2017 |
Locations
Countries of recruitment
- Sweden
Study participating centre
75185
Sweden
Sponsor information
University/education
Uppsala universitet
Womens and childrens health
Akademiska sjukhuset
Uppsala
75185
Sweden
"ROR" |
https://ror.org/048a87296 |
|---|
Funders
Funder type
Charity
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer review journal as well as presentations at academic conferences. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/06/2020 | 12/02/2021 | Yes | No |
Editorial Notes
12/02/2021: Publication reference added.
