Trial Description Organizational Data

DRKS-ID: DRKS00003856
Date of Registration in DRKS: 2012/05/04
Date of Registration in Partner Registry or other Primary Registry: [---]*
PLEASE NOTE: This trial has been registered retrospectively.
Trial Description
Title
Reducing stress and supporting positive relations in families of young children
with type 1 diabetes: A randomized controlled study for evaluating the effects of
the DELFIN parenting program
Trial Acronym
DELFIN parenting program
URL of the trial
[---]*
Brief Summary in Lay Language
A structured behavioral group training (DELFIN) for parents of children with
diabetes type 1 was evaluated within a randomized controlled trial (waiting list
control group), intending to reduce parenting stress and to improve parenting
skills (especially in parenting conflict situations).
Brief Summary in Scientific Language
A randomized controlled study was conducted between July 2008 and September
2010, at a childrens’ hospital in Hannover with parents of children with diabetes
type 1 (intervention group n=37; control group n=28). Parenting skills, parents’
psychological burden, childrens' behavior difficulties and quality of metabolic
control were assessed before, 3 months after and 12 months after participating in
the parenting training program.
Organizational Data
DRKS-ID: DRKS00003856
Date of Registration in DRKS: 2012/05/04
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee Nr.: 4958 , Ethikkommission der Medizinischen Hochschule
Hannover
Secondary IDs
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DRKS-ID: DRKS00003856
Date of Registration in DRKS: 2012/05/04
Date of Registration in Partner Registry or other Primary Registry: [---]*
Universal Trial Number (UTN): U1111-1130-2691
Health condition or Problem studied
Free text: parenting problems in parents with children with diabetes type 1
Interventions/Observational Groups
Arm 1: Outpatient care as usual; after post-measurement completion (4-5
months after baseline measurement) parents of the waiting list control group
were offered to attend a behavioral parenting group training to improve
parenting skills and reduce parenting stress.
Arm 2: Outpatient care as usual and a behavioral parenting group training to
improve parenting skills and reduce parenting stress. The DELFIN program
(DELFIN - The parenting program for parents of children with diabetes type 1)
is a structured group intervention. Parents meet weekly for a 2 hour session
over a period of 5 weeks and receive an individual phone contact after the last
group meeting. They are trained in groups with up to 7 families. In between
the sessions practical skill training is boosted by setting homework. The
contents of the first session are goal setting, processing dysfunctional
cognitions and the introduction of communication skills. Session 2 deals with
the practical training of positive communication skills and building a positive
parent-child relationship. Strategies for handling diabetes specific and nonspecific conflict situations are introduced and trained using role playing in
session 3 and 4. Session 5 focuses on individual situations and practising new
strategies in them. Parents are supposed to try those new strategies out with
regard to their individual goals and report their experiences within an
individual phone contact.
Characteristics
Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: No treatment
Purpose: Treatment
Assignment: Parallel
Phase: N/A
Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A
Primary Outcome
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DRKS-ID: DRKS00003856
Date of Registration in DRKS: 2012/05/04
Date of Registration in Partner Registry or other Primary Registry: [---]*
Parenting skills, parents’ psychological burden, children's behavior difficulties
were collected before and 3 months after the intervention. Additionally at 12
month follow-up for the parents of the intervention group. The "Parenting Scale"
(Arnold, O'Leary, Wolff & Acker, 1993) was used in the German version
("Erziehungsfragebogen", Miller, 2001) to measure parent education skills in
conflict situations. The Questions to Education Behavior ("Fragen zum
Erziehungsverhalten", Miller, 2001; Heinrichs, Hahlweg, Bertram, Kuschel,
Naumann & Harstick, 2006) form was used to assess the amount of positive,
helping and reinforcing parental behavior. The Depression-Anxiety-Stress Scale
(Lovibond & Lovibond, 1995) was used in the German version ("Depressions-AngstStress Skala", Köppe, 2001) to measure depressed mood, anxiety and stress.
Further the German version of the "Strengths and Difficulties Questionnaires"
(Goodman, 1999; Woerner, Becker & Rothenberger, 2004) was used to assess
potential child difficulties (emotional symptoms, hyperactivity, conduct and peer
relationship problems) and child's prosocial behavior.
Secondary Outcome
Quality of metabolic control was assessed before and 3 months after the
intervention. Additionally there was a follow-up at 12 months for the intervention
group. The A1c, hospitalization due to ketoazidosis and episodes of severe
hypoglycemia were collected.
Countries of recruitment
DE Germany
Locations of Recruitment
University Medical Center Hannover
Recruitment
Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2008/08/01
Target Sample Size: 70
Monocenter/Multicenter trial: Monocenter trial
National/International: National
Inclusion Criteria
Gender: Both, male and female
Minimum Age: no minimum age
Maximum Age: no maximum age
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DRKS-ID: DRKS00003856
Date of Registration in DRKS: 2012/05/04
Date of Registration in Partner Registry or other Primary Registry: [---]*
Additional Inclusion Criteria
at least one child diagnosed with diabetes type 1 aged 2-10 years; no other
psychological interventions of parents or child; able to read and speak German
Exclusion criteria
psychological intervention of parent or child, not able to read or speak German
Addresses
Primary Sponsor
Medizinische Hochschule Hannover
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: www.mh-hannover.de
Contact for Scientific Queries
Medizinische Hochschule Hannover
Ms. Dr. Heike Saßmann
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone: +49 (0)511 532 4436
Fax: +49 (0)511 532 4214
E-mail: sassmann.heike at mh-hannover.de
URL: www.mh-hannover.de
Contact for Public Queries
Medizinische Hochschule Hannover
Ms. Dr. Heike Saßmann
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone: +49 (0)511 4436
Fax: +49 (0)511 4214
E-mail: sassmann.heike at mh-hannover.de
URL: www.mh-hannover.de
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DRKS-ID: DRKS00003856
Date of Registration in DRKS: 2012/05/04
Date of Registration in Partner Registry or other Primary Registry: [---]*
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
German Diabetes Association (DDG)
Reinhardtstr. 31
10117 Berlin
Germany
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: [---]*
Status
Recruitment Status: Recruiting complete, follow-up complete
Study Closing (LPLV): 2010/11/01
Trial Publications, Results and other documents
Paper Saßmann H, deHair M, Danne T, Lange K (2012) Reducing stress and
supporting positive relations in families of young children with type 1 diabetes: A
randomized controlled study for evaluating the effects of the DELFIN parenting
program. BMC Pediatr 12 (1): 152. (Epub ahead of print)
* This entry means the parameter is not applicable or has not been set.
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