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Family Networks (FaNs) for Children With Developmental Disorders and Delays (FaNs)

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ClinicalTrials.gov Identifier: NCT02792894
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : June 4, 2019
Sponsor:
Collaborators:
Grand Challenges Canada
Autism Speaks
World Health Organization
Institute of Psychiatry, Benazir Bhutto Hospital, Rawalpindi, Pakistan
Institute of Psychology, Health and Society, University of Liverpool, UK
Information provided by (Responsible Party):
Syed Usman Hamdani, Human Development Research Foundation, Pakistan

Brief Summary:
Over 6% of children in Pakistan suffer from a developmental disorder (intellectual disability or Autistic spectrum disorder) and most receive no intervention.In an earlier proof of concept study, the investigators integrated social, technological and business innovations to develop and successfully pilot a sustainable service for such children in one rural population of 30,000. Affected families were identified through a mobile phone-based interactive voice response system, and organised into family networks. 'Champion' family volunteers were trained in evidence-based interventions. A Tablet-based android application was developed for training, monitoring and supervision of the champions, based on the World Health Organization's guidelines. The champions delivered the intervention to other families in the network. The project was sustainable and demonstrated significant improvements in the lives of children and their families in the first 6 months of its operation. The investigators are scaling-up this intervention to a population of 1 million. The investigators aim to evaluate the effectiveness and cost effectiveness of the scaled-up programme using cluster randomized control trial nested within the scale-up study.

Condition or disease Intervention/treatment Phase
Neurodevelopmental Disorders Developmental Disabilities Behavioral: Family networks program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Family Networks (FaNs) for Children With Developmental Disorders and Delays Program: A Cluster Randomized Control Trial
Actual Study Start Date : April 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Enhanced Usual Care (EUC)
Enhanced Usual Care comprises of normal routine visits conducted by the local community health workers / Lady Health Workers (LHWs). Care is enhanced in 2 ways: (a) LHWs in the EUC arm will receive training in identifying children with developmental disorders and delays, as well as making referrals to their primary care physicians for treatment using the WHO mhGAP training program for developmental disorders and (b) The primary care physicians will receive the training in WHO mental health GAP(mhGAP) program developmental disorders module, by WHO Collaborating Center in Rawalpindi, Pakistan.
Experimental: Family Networks program
Intervention is administered once weekly over 9-10 weeks in a group format over 3 hours per sessions. Family networks Program (FaNs) is based on WHO mhGAP module for developmental disorders and incorporates WHO Parent Skills Training program for children with developmental disorders and delays. Parents Skills Training Program includes modules on communication, play, daily living skills, managing challenging behavior, coping with stress. Intervention is provided by the family volunteers (members of community, mostly women, who have a child affected in their families).
Behavioral: Family networks program
Intervention, Family networks Program (FaNs), is administered once weekly over 9-10 weeks in a group format over 3 hours per sessions. Family networks Program (FaNs) is based on WHO mhGAP module for developmental disorders and incorporates WHO parent skills training program for children with developmental disorders and delays. Parents Skills Training Program includes modules on communication, play, daily living skills, managing challenging behavior, coping with stress. Intervention is provided by the family volunteers (members of community, mostly women, who have a child affected in their families).




Primary Outcome Measures :
  1. WHO Disability Assessment Schedule (children version)(WHODAS-Child) [ Time Frame: Change in WHODAS Child Global Disability Score at 6 months follow up from baseline assessment ]
    WHODAS child is a Parent rated , 36 items scale. Items are distributed across 6 domains to measure functional impairment in children i.e cognition, mobility, self-care, getting along, life activities, participation in society. Each item is rated on a 5-point Likert scale (0 = no functional impairment, 4 = extreme impairment/cannot do). Global Disability Score (range 0-100) is estimated by averaging domain scores.


Secondary Outcome Measures :
  1. Caregiver-child interaction (CCX) videos [ Time Frame: Baseline (Pre treatment) and follow up (6 months after the baseline) ]
    A 20-25 minutes video will be recorded to capture caregiver-child interaction. Caregivers will be asked to play with the child using a standard toy kit for 12 minutes and to perform a home routine (i.e dressing, eating, book reading etc.). caregiver-child interaction videos will be coded for child outcome including social communication and joint engagement as well as the primary caregiver outcome, care giver's adoption and implementation of intervention strategies.

  2. Strengths and Difficulties Questionnaire [ Time Frame: Baseline (Pre treatment) and follow up (6 months after the baseline) ]
    Parent rated, 25 items scale. Items are distributed over 5 domains: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Each item is rated on a 3-point Likert scale (0 = not true, 1 = somewhat true, 2 = certainly true). Total difficulty score is calculated by adding all the domain scores except prosocial problems.

  3. Family Empowerment Scale [ Time Frame: Baseline (Pre treatment) and follow up (6 months after the baseline) ]
    Parent rated, 34 items scale, consisting of 3 subscales: The family subscale (12 items) refers to the parents' management of everyday situations. The service system subscale (12 items) refers to parents' acting to obtain services to meet the child's needs. The community subscale (10 items) refers to parents' advocacy for improving services for children in general. Each item is rated on a 5-point Likert scale (1 = not true at all to 5 = very true). Scores are summed across all items for each subscale with higher scores indicating relatively more empowerment.

  4. Inventory of Stigmatizing Experiences (Family version): [ Time Frame: Baseline (Pre treatment) and follow up (6 months after the baseline) ]
    Interview-based measure of the extent of stigma faced by family. Seven items, each item is rated on a 5-point Likert scale (1 = never to 5 = always). The responses are recoded into a binary variable with 1 reflecting presence of stigma and 0 reflecting absence of stigma. Scores are summed across all items with a maximum score of 7, with lower scores indicating relatively less stigma.

  5. Pediatric Quality of Life (PedsQL) family impact module [ Time Frame: Baseline (Pre treatment) and follow up (6 months after the baseline) ]
    The 36-item PedsQL™ Family Impact Module Scales encompass 6 sub-scales measuring parent self-reported functioning: 1) Physical Functioning (6 items), 2) Emotional Functioning (5 items), 3) Social Functioning (4 items), 4) Cognitive Functioning (5 items), 5) Communication (3 items), 6) Worry (5 items), and 2 scales measuring parent-reported family functioning; 7) Daily Activities (3 items) and 8) Family Relationships (5 items). Items are rated on a 5 point Likert scale (0 never to 4 almost always). For ease of interpretability, items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life).

  6. Client Services Receipt Inventory [ Time Frame: Baseline (Pre treatment) and follow up (6 months after the baseline) ]
    Client Services Receipt Inventory has been adapted for use in children and families with developmental disorders.

  7. Clinical global impression [ Time Frame: Baseline (Pre treatment) and follow up (6 months after the baseline) ]
    Clinical global impression (CGI) measures severity of challenges in social communication (rated from 1-7) (b) improvement in social communication at 6 months follow up (rated from 1-7). The CGI will be rated from the CCX videotapes by observers blinded to intervention allocation.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged between 2-12 years,
  • Screen positive on any of the Ten Questions screen questionnaire items # 1,4,5,7,8,9,10 for developmental disorders and delays.
  • Developmental disorder and delay present according to clinical assessment (History & clinical examination for developmental delay in motor, communication, social, cognitive, daily living skills domains according to mhGAP developmental disorders guidelines for clinical assessment

Exclusion Criteria:

  • Co-morbid physical or mental conditions in the child requiring inpatient hospitalization
  • Deafness or blindness in the child
  • Primary caregiver not available or unwilling to participate in the intervention program for 6 months
  • Physical or mental conditions in the primary caregiver needing inpatient hospitalization or frequent outpatient visits (more than two times a month)
  • Written consent not obtained for participation in the trial by the primary caregiver

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792894


Locations
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Pakistan
Mandra Intellectual and Neurodevelopmental Disorders (MIND) Center
Gujar Khan, Punjab, Pakistan
Sponsors and Collaborators
Human Development Research Foundation, Pakistan
Grand Challenges Canada
Autism Speaks
World Health Organization
Institute of Psychiatry, Benazir Bhutto Hospital, Rawalpindi, Pakistan
Institute of Psychology, Health and Society, University of Liverpool, UK
Investigators
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Study Director: Atif Rahman, PhD University of Liverpool
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Syed Usman Hamdani, Deputy Director, Implementation Research Unit, Human Development Research Foundation, Human Development Research Foundation, Pakistan
ClinicalTrials.gov Identifier: NCT02792894    
Other Study ID Numbers: 746-05
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Syed Usman Hamdani, Human Development Research Foundation, Pakistan:
cluster randomized trial
developmental delays
neurodevelopmental disorders
autism
intellectual disability
low resource settings
family volunteers
Additional relevant MeSH terms:
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Disease
Developmental Disabilities
Neurodevelopmental Disorders
Pathologic Processes
Mental Disorders