Evaluation of the effectiveness of family education in improving the sleep function of children 3 to 6 years old with sleep problems

Evaluation of the effectiveness of family education in improving the sleep function of children 3 to 6 years old with sleep problems

Randomized, single-blinded parallel group trial with on 52 children.

Children with sleep problems who refer to the rehabilitation centers of Tehran University of Rehabilitation Sciences and Social Health, if they are eligible, will be included in the study and will be randomly assigned to the intervention and control groups. The study will be conducted in a blinded manner. The evaluator does not know about the allocation of people.

Inclusion criteria:Child with sleep problems from ages 3 to 6 years.Parent must participate in all workshop sessions.Parental consent for their children's participation.Exclusion criteria:Existence of obvious physical,sensory,cognitive and motor disorders including cerebral-palsy,ADHD,autism spectrum,developmental delay which is checked through interviewing parents,taking history and CPRS-48questionnaire.The child use medications that may affect sleep.

The control group will not receive any intervention.The intervention-group receives a 4-week educational program during the first, second and fourth weeks(2 hours each session)in the form of a family education workshop under the following headings:an introduction to sleep,providing good sleep exercises,teaching behavioral and environmental strategies,Scoreboard training.For deep interaction,8 families are present.For continuous interaction with parents,creating a group in virtual space consisting of researcher and families and telephone calls are used.

Resistance during sleep؛Sleep delay؛Sleep duration؛Anxiety at bedtime؛Quality of life of the child؛Quality of life of parents؛Parental stress

To allocate the samples, random block allocation method is used and it is done in several steps. First, a random sequence with blocks of 4 is created and Random Allocation software is used. Then, to hide the random allocation, sealed opaque envelopes are used in a random sequence. Based on the sample size of the research, a number of envelopes with aluminum foil (for lack of clarity of the contents of the envelopes), will be prepared and each of the created random sequences are recorded on a card and the cards are placed inside the envelopes in order. In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed inside the boxes in order. At the time of registration of the participants, according to the order of entry of the eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. In this method, the people who check the Inclusion and Exclusion criteria and the person who performs the allocation process are independent.

The researcher of the study is aware of the allocation of children's parents to the control and intervention groups.Measurements are conducted by an evaluator (occupational therapist) masked to study design and group allocation. Also in order to maintain blinding, the questionnaires were completed in one session with the presence of all participants (control and intervention group) and evaluator (occupational therapist).