Teleassisted caregiver mediated intervention for children with Disorders of Intellectual Development - A feasibility study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1. Completion of participation in the study with structured feedback from care-provider (trainee therapist) and caregiver independently (verified by Guide) about
研究概览
简要总结
This study is a quasi-experimental Interventional study aiming to assess the feasibility of a caregiver-mediated intervention for children with Disorders of Intellectual Development (DID) delivered via telehealth. It involves two groups - an Intervention group and a Control group receiving treatment as usual (TAU). The study aims to recruit 70 caregivers of children aged 2 to 9 with DID from KMC Manipal. Caregivers will be randomly assigned to either group after providing informed consent, including consent for video-recording of online sessions. Baseline and final assessments will be conducted in-person (VSMS, BASIC-MR, FISC-MR), with telepsychiatry guidelines followed during online sessions. The intervention group will receive four online intervention sessions. The primary quantitative outcome measure will be the change in Family Interview for Stress and Coping in Mental Retardation (FISC-MR) Score - Coping Subdomain, while qualitative outcomes will assess participation completion, protocol fidelity, participant comfort, and difficulties faced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age of children- 2 to 9 years.
- •2.Treated under the Department of Psychiatry or Pediatrics, KMC Manipal.
- •3.Diagnosis of Disorder of Intellectual Development according to ICD
- •4.Informed consent given by caregiver/ parent.
- •5.Availability of a computer, phone, tablet with high-speed internet to have online video-conferencing sessions.
排除标准
- •1.Parents’ participation in any other programs involving parent training for building functional adaptive skills or behavior modification in their child.
- •2.Children undergoing specific behavioral training for functional adaptive skills in special schools 3.Children/caregiver having acute medical or psychiatric conditions that will interfere with their participation in the study.
- •4.Moderate to severe hearing loss or visual impairment.
- •5.Severe locomotor disability.
- •6.Refusal to consent for the study.
结局指标
主要结局
1. Completion of participation in the study with structured feedback from care-provider (trainee therapist) and caregiver independently (verified by Guide) about
时间窗: Baseline and 12 weeks
a. Dropout rates in intervention versus control group.
时间窗: Baseline and 12 weeks
b. Completeness in terms of sessions attended.
时间窗: Baseline and 12 weeks
c. Fidelity to protocol (of therapist and parent).
时间窗: Baseline and 12 weeks
d. Comfort of caregiver to utilize the intervention (practicality in terms of resources, time, and commitment).
时间窗: Baseline and 12 weeks
e. Any difficulties the caregiver had during the intervention (qualitative feedback).
时间窗: Baseline and 12 weeks
2. Change in a Family interview for stress and coping in mental retardation (FISC-MR) Score – Coping Subdomain.
时间窗: Baseline and 12 weeks
次要结局
- CHILD RELATED OUTCOMES(1. Attainment of functional skills at follow-up (Measured by VSMS and BASIC-MR).)
研究者
Ananya Malhotra
Kasturba Medical College, Manipal