Plain English Summary
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
Study website
Contact information
Type
Scientific
Contact name
Mrs Anna Fäldt
ORCID ID
http://orcid.org/0000-0001-7257-8758
Contact details
Uppsala universitet
CHAP
Munin
Uppsala
75185
Sweden
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
ComAlong Toddler - Early identification and randomized control trail of a parental course and guidance in the home environment
Acronym
ComAlong Toddler
Study hypothesis
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
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
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
Overall study end date
30/06/2022
Reason abandoned (if study stopped)
Eligibility
Participant 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.
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.
Participant 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
Recruitment start date
01/09/2015
Recruitment end date
30/06/2017
Locations
Countries of recruitment
Sweden
Study participating centre
Uppsala University
Uppsala
75185
Sweden
Sponsor information
Organisation
Uppsala University
Sponsor details
Uppsala universitet
Womens and childrens health
Akademiska sjukhuset
Uppsala
75185
Sweden
Sponsor type
University/education
Website
ROR
Funders
Funder type
Charity
Funder name
Foundation Sunnerdahls Disability Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Queen Silvia Jubilee Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Department of Research and Development - Uppsala County Council
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Uppsala University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer review journal as well as presentations at academic conferences.
Intention to publish date
30/06/2019
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/06/2020 | 12/02/2021 | Yes | No |