NCT02641275

Brief Summary

The relentless progressive process of muscular dystrophy requires extraordinary medical, physical, and emotional care with severe consequences for caring parents (increased stress and diminished social, psychological and physical well-being). Despite the obvious need of support for parents only few and weak data exist regarding efficiency and efficacy of specific interventions supporting parental resilience and coping strategies. The presenting study aims to fill this gap by evaluating the efficacy of a structured self-management training for parents of children with severe progressive muscular dystrophy compared to parents receiving treatment as usual (TAU). In addition, investigators measure established biomarkers of psychosocial stress, such as pro-inflammatory cytokines, which will be used to monitor physiological changes with assumed significance for parental health.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
1 year until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

1.9 years

First QC Date

November 9, 2015

Last Update Submit

August 14, 2019

Conditions

Muscular Dystrophies

Keywords

Parental stressMuscular DystrophiesCopingParental support

Outcome Measures

Primary Outcomes (3)

  • Action Orientation Questionnaire (HAKEMP)

    Kuhl and co-workers introduced a special questionnaire (HAKEMP) to assess the tendency of people in concrete situations to revert to an action-oriented or state-oriented condition in 24 items.

    1 1/2 year with control group

  • Self-efficacy: Thought control of action (SWE)

    Quantify improved parental resilience and coping strategies facing chronic stress. Questionnaire developed by Jerusalem and Schwarzer, 1981, revised 1999 to test general self-efficacy in 10 items.

    1 1/2 year with control group

  • Change in Experiencing and Behaviour post-intervention (VEV)

    VEV is a questionnaire developed by Ziele and Kopf-Mehnert, 1978 to test post-intervention change in experiencing and behavior along with a retrospective life-event checklist and a self-rating questionnaire in 42 items. Other than previous questionnaires VEV will be applied only after intervention.

    1 1/2 year with control group

Secondary Outcomes (1)

  • Number of Participants With Sum of Abnormal Laboratory Values Concerning Biomarkers of psychosocial stress

    1 1/2 year with control group

Study Arms (2)

Intervention

EXPERIMENTAL

Structured self-management-training (incl. systemic analysis, coaching, teaching) in 4 sessions.

Other: Structured self-management-training

Control group

NO INTERVENTION

no intervention other than existing support (see exclusion criteria). However, intervention will be offered and studied secondary as well (after 1 1/2 year of no intervention).

Interventions

Structured self-management-trainingOTHER

Structured self-management-training (incl. systemic analysis, coaching, teaching) in 4 sessions

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parents with at least one living child affected by chronic muscular dystrophy

You may not qualify if:

  • Dying of a child during intervention and analysis.
  • Severe/significant psychological disorder (in case of existing psychological support, participation should be agreed/supported by therapist, too)
  • Recent or concomitant self-management training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Muscular Dystrophies

Condition Hierarchy (Ancestors)

Muscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jürg C Streuli, MD PhD

    University Children's Hospital, Zurich

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2015

First Posted

December 29, 2015

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

August 19, 2019

Record last verified: 2019-08