Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes

Not Applicable

Completed

• Conditions: Paediatric diabetes (type 1); Nutritional, Metabolic, Endocrine; Diabetes

• Registration Number: ISRCTN61568050
• Lead Sponsor: Cardiff University (UK)

Brief Summary

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20144218 2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21851764

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-16
• Study Completion: 2009-03-31
• Last Update Posted: 12 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 700

Inclusion Criteria

For teams/clinics:
Teams include a paediatrician with an interest in diabetes and a diabetes specialist nurse

For patients:
1. Type 1 diabetes
2. Aged 4-15
3. Under care of diabetes team for duration of trial
4. Diagnosed more than 1 year ago
5. Parental/guardian and child consent (or assent where appropriate) given
6. ability of patient and at least one parent/guardian to complete study materials (questionnaires)

Children aged 4-15 will be included to reflect as broad a range of patients as possible. Young people aged 16+ may be in transition between paediatric and adult services at some point during the trial and are therefore excluded. Data collected from questionnaires is crucial to determining the effectiveness of the intervention. However, questionnaires are only available in English, as measures included have not been validated in other languages: this would be beyond the scope of the current study.; For teams/clinics:
Teams include a paediatrician with an interest in diabetes and a diabetes specialist nurse

For patients:
1. Type 1 diabetes
2. Aged 4-15
3. Under care of diabetes team for duration of trial
4. Diagnosed more than 1 year ago
5. Parental/guardian and child consent (or assent where appropriate) given
6. ability of patient and at least one parent/guardian to complete study materials (questionnaires)

Children aged 4-15 will be included to reflect as broad a range of patients as possible. Young people aged 16+ may be in transition between paediatric and adult services at some point during the trial and are therefore excluded. Data collected from questionnaires is crucial to determining the effectiveness of the intervention. However, questionnaires are only available in English, as measures included have not been validated in other languages: this would be beyond the scope of the current study.

Exclusion Criteria

For teams/clinics:
<40 potentially eligible children/adolescents (diagnosed more than 1 year ago) attending the clinic

For patients:
1. Not under care of parent or guardian (i.e. a looked after child)
2. Co-morbid chronic illness likely to impact on HbA1c independent of patient's ability to manage their diabetes (e.g. condition requiring steroid treatment, cystic fibrosis, renal failure)
3. In receipt of ongoing psychiatric/psychological therapy at the start of the study
4. Other patients judged by their clinical carer to be vulnerable due to existing medical or social condition

Criteria have been designed in order to be as inclusive as possible. Clinics with less than 40 patients will be excluded due to practicalities of recruiting sufficient patient numbers (30 per clinic) and fewer than 40 patients is not felt to constitute an adequate size for a specialist children's service. It is unfortunately not feasible to recruit children under a care order, due to the practical difficulties of obtaining appropriate consent: this is felt to be outside the scope of the current study. However, patients attending clinics where health professionals have undergone training are likely to benefit from increased awareness of psychosocial issues.; For teams/clinics:
<40 potentially eligible children/adolescents (diagnosed more than 1 year ago) attending the clinic

For patients:
1. Not under care of parent or guardian (i.e. a looked after child)
2. Co-morbid chronic illness likely to impact on HbA1c independent of patient's ability to manage their diabetes (e.g. condition requiring steroid treatment, cystic fibrosis, renal failure)
3. In receipt of ongoing psychiatric/psychological therapy at the start of the study
4. Other patients judged by their clinical carer to be vulnerable due to existing medical or social condition

Criteria have been designed in order to be as inclusive as possible. Clinics with less than 40 patients will be excluded due to practicalities of recruiting sufficient patient numbers (30 per clinic) and fewer than 40 patients is not felt to constitute an adequate size for a specialist children's service. It is unfortunately not feasible to recruit children under a care order, due to the practical difficulties of obtaining appropriate consent: this is felt to be outside the scope of the current study. However, patients attending clinics where health professionals have undergone training are likely to benefit from increased awareness of psychosocial issues.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure for patients is glycaemic control assessed using HbA1c at 1 year. ;The primary outcome measure for patients is glycaemic control assessed using HbA1c at 1 year.