How is the research being carried out?

Families who enrol in The Cleft Collective Cohort Studies will be taken through a number of key stages: recruitment, follow-up and sub-studies.

Stage 1: Recruitment

Being approached to take part

Families will be approached to take part at one of three possible time points: before the child’s birth, after the child’s birth, or around the time of the child’s 5-year audit clinic - find about more of each of these time points. In most cases, the families will be approached by a member of their cleft team. Occasionally, they may be approached by another member of staff at their hospital. Leaflets (PDF, 413kB) containing information about the research will also be distributed to families via the Cleft Lip and Palate Association (CLAPA).

Families will then be offered a Starter Pack, which contains:

• A Participant Information Sheet (download an example (PDF, 596kB))
• A simplified diagram explaining what information we will collect, when, why and from whom  (download download an example (PDF, 82kB))
• A timeline, explaining what we will ask families to do and when (download an example (PDF, 63kB))
• Consent Forms for the parents and child (download an example (PDF, 92kB))
• Questionnaire for the parents, to collect environmental and psychological information (download an example (PDF, 297kB))

Families will be asked to read the information provided in the Starter Pack and to decide whether they would like to take part in The Cohort Studies. If families have any questions about the research and what they are being asked to do, they can get in touch with their cleft team, or with The Cleft Collective directly.

Filling in consent forms and questionnaires

Once a family has decided to take part in The Cohort Studies, they will be asked to do the following:

• Initial and sign Consent Forms for the parent(s) and the child and return them to their cleft team
• Fill in the Questionnaire and return it to the research team
• Provide saliva samples using the kits provided and return them to the laboratory in Bristol

Pre-paid envelopes for returning consent forms, questionnaires and saliva samples are provided in the Starter Pack.

Stage 2: Follow-up

A Cohort Study involves following families as their child grows up, to help us answer some of the important research questions about cleft. We plan to contact families at a number of key time points in their child’s development, and ask them to complete a follow-up questionnaire. These time points include:

• When the child is aged 18 months
• When the child is aged 3 years
• When the child is aged 5 years
• When the child is aged 7-8 years

We hope to follow up families for a number of years after this, depending on how much funding is available.

We may also contact families very occasionally for one of the following reasons:

• To remind them to return a consent form, questionnaire or saliva sample to us
• To send them twice yearly newsletters (optional)
• To invite them to participate in other cleft research (optional)

Families have the right to withdraw from the Cohort Studies at any time. For more information about this, please see our Withdrawal of consent (PDF, 210kB).

Stage 3: Sub-studies

The main Cohort Studies involve collecting genetic, environmental and psychological information from families. There will also be a number of sub-studies which families will be invited to take part in. This includes a speech and language study and 3D-imaging.

There may also be other opportunities to take part in smaller cleft studies as the research goes on. For examples of some of our previous studies, visit our research progress page.

Find out more details about what information we are collecting, why we are collecting it and what will happen to the information families provide.

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