Condition category
Mental and Behavioural Disorders
Date applied
09/06/2016
Date assigned
09/08/2016
Last edited
05/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Anna Fäldt

ORCID ID

http://orcid.org/0000-0001-7257-8758

Contact details

Uppsala universitet
CHAP
Munin
Uppsala
75185
Sweden

Additional identifiers

EudraCT 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

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

Trial setting

Other

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2015

Overall trial end date

30/06/2022

Reason abandoned

Eligibility

Participant inclusion criteria

Children:
1. Children < 30 months of age
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

Patient

Age group

Child

Gender

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

Trial 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

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

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes