Trial document





This trial has been registered retrospectively.
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  DRKS00003856

Trial Description

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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

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Trial Acronym

DELFIN parenting program

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URL of the Trial

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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).

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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.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003856
  •   2012/05/04
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  •   no
  •   Approved
  •   4958, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  •   U1111-1130-2691 
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Health Condition or Problem studied

  •   parenting problems in parents with children with diabetes type 1
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Interventions/Observational Groups

  •   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.
  •   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 non-specific 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.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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-Angst-Stress 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.

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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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2008/08/01
  •   70
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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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

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Exclusion Criteria

psychological intervention of parent or child, not able to read or speak German

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Addresses

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    • Medizinische Hochschule Hannover
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  Dr.  Heike  Saßmann 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  Dr.  Heike  Saßmann 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • German Diabetes Association (DDG)
    • Reinhardtstr. 31
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/11/01
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Trial Publications, Results and other Documents

  •   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)
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* This entry means the parameter is not applicable or has not been set.