Early Intervention for Developmental Delay

NCT ID: NCT03223688

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-12
• Study Completion Date: 2017-05-11

Brief Summary

This study aims to investigate the effectiveness of early intervention program in Department of Children and Adolescent Psychiatry, Kaohsiung Chang Gung Memorial Hospital. The investigators assume that the frequency of early-intervention and degree of family involvement will be associate with the treatment outcome.

Detailed Description

This prospective, non-randomized, open-label study is performed to assess the effects of adjunctive SI in the family-based treatment program of children with developmental delay (DD). The study subjects are children with DD who attended an early intervention (EI) program at Kaohsiung Chang Gung Memorial Hospital, which is the largest general hospital in the Southern Taiwan. Each participating child undergo a joint assessment by a pediatrician, a rehabilitation doctor, a child psychiatrist, a speech therapist, a physical therapist, an occupational therapist, and a social worker. Once the diagnosis of developmental delay is confirmed, the child will be scheduled for prescribed family-based early intervention in the same hospital. Children (between 2 to 4 years old) who attend the program will be enrolled in this study. Informed consent will be obtained from the children and their primary caregivers after they received a complete description of the study. The participants are categorized into three different groups based on their intervention method. The choice of intervention method will be according to the willingness and expedience of the children's caregivers.

Conditions

Child Development; Developmental Delay; Early Intervention

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Day-Care early intervention program

The daily treatment session had eight children along with their major caregivers. The treatment was conducted by two experienced occupational therapists (OT), and each session lasted for four hours in the week-day morning with a 10-minute break. The goal of the sessions was to enhance children's development through cognitive training, behavioral modification plan and parenting skill training. Said therapists assisted the caregivers in improving their nurturing and parenting skills with their children, as well as their techniques with regards to influencing them.

Group Type: EXPERIMENTAL

Day-Care early intervention program

Intervention Type: BEHAVIORAL

The daily treatment session had eight children along with their major caregivers. The treatment was conducted by two experienced occupational therapists (OT), and each session lasted for four hours in the week-day morning with a 10-minute break. The goal of the sessions was to enhance children's development through cognitive training, behavioral modification plan and parenting skill training.

OPD+SI intervention program

The treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training. Adjunctive SI therapy was also performed by said OT for improving children's sensory motor development in an additional hour.

Group Type: EXPERIMENTAL

OPD+SI intervention program

Intervention Type: BEHAVIORAL

The treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training. Adjunctive SI therapy was also performed by said OT for improving children's sensory motor development in an additional hour.

OPD intervention program

The treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training.

Group Type: ACTIVE_COMPARATOR

OPD intervention program

Intervention Type: BEHAVIORAL

The treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training.

Interventions

Day-Care early intervention program

The daily treatment session had eight children along with their major caregivers. The treatment was conducted by two experienced occupational therapists (OT), and each session lasted for four hours in the week-day morning with a 10-minute break. The goal of the sessions was to enhance children's development through cognitive training, behavioral modification plan and parenting skill training.

Intervention Type: BEHAVIORAL

OPD+SI intervention program

The treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training. Adjunctive SI therapy was also performed by said OT for improving children's sensory motor development in an additional hour.

Intervention Type: BEHAVIORAL

OPD intervention program

The treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training.

Intervention Type: BEHAVIORAL

Other Intervention Names

Adjunctive Sensory Integration (SI) Therapy

Eligibility Criteria

Inclusion Criteria

• Children with Developmental Delay
• The caregivers are able to participate in the treatment program

Exclusion Criteria

• Autism
• Cerebral palsy

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wang Liang-Jen

Associate Professor and Visiting Staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liang-Jen Wang

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital, Kaohsiung, Taiwan

Other Identifiers

105-1742C1

Identifier Type: -

Identifier Source: org_study_id