- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02792894
Family Networks (FaNs) for Children With Developmental Disorders and Delays (FaNs)
January 25, 2021 updated by: Syed Usman Hamdani, Human Development Research Foundation, Pakistan
Evaluation of Family Networks (FaNs) for Children With Developmental Disorders and Delays Program: A Cluster Randomized Control Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
540
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab
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Gujar Khan, Punjab, Pakistan
- Human Development Research Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 months to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
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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).
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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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Developmental Disorders- Children Disability Assessment Schedule (DD-CDAS)
Time Frame: Change in DD-CDAS score at 6 months post-intervention
|
The DD-CDAS is a 36-item questionnaire measuring functioning and disability.
The 36 items are rated on a five-point Likert scale (1=none to 5=extreme/cannot do).
The items represent cognition, mobility, self-care, getting along with others, life activities, and participation in the society.
The raw scores are sum across all the items of each domain and all 36 items for a tool.
Domain and total raw scores are transformed into a range from 0 to 100.
The tool has been validated for children with developmental disorders in Pakistan (DD-CDAS) by our group (Hamdani et al, 2020).
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Change in DD-CDAS score at 6 months post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregiver-Child Interaction
Time Frame: Baseline (Pre treatment) and follow-up (6 months post-intervention)
|
Fifteen minutes video will be recorded to capture caregiver-child interaction.
Caregivers will be asked to try home routines involving the child (e.g.
feeding the child, performing domestic chores) or play based routines (e.g.
playing with toys or reading a book) with their child.
Caregiver's facilitators and interrupters (including child's engagement and distress during social communication) and joint engagement will be rated.
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Baseline (Pre treatment) and follow-up (6 months post-intervention)
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Strengths and Difficulties Questionnaire (SDQ)
Time Frame: Baseline (Pre treatment) and follow up (6 months post-intervention)
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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.
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Baseline (Pre treatment) and follow up (6 months post-intervention)
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Family Empowerment Scale (FES)
Time Frame: Baseline (Pre treatment) and follow up (6 months post-intervention)
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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.
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Baseline (Pre treatment) and follow up (6 months post-intervention)
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Inventory of Stigmatizing Experiences (Family version)
Time Frame: Baseline (Pre treatment) and follow up (6 months post-intervention)
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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.
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Baseline (Pre treatment) and follow up (6 months post-intervention)
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Pediatric Quality of Life (PedsQL) family impact module
Time Frame: Baseline (Pre treatment) and follow up (6 months post-intervention)
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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).
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Baseline (Pre treatment) and follow up (6 months post-intervention)
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Client Services Receipt Inventory (CSRI)
Time Frame: Baseline (Pre treatment) and follow up (6 months post-intervention)
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Client Services Receipt Inventory has been adapted for use in children and families with developmental disorders.
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Baseline (Pre treatment) and follow up (6 months post-intervention)
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Clinical Global Impression (CGI)
Time Frame: Baseline (Pre treatment) and follow up (6 months post-intervention)
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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.
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Baseline (Pre treatment) and follow up (6 months post-intervention)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Atif Rahman, PhD, University of Liverpool
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hamdani SU, Minhas FA, Iqbal Z, Rahman A. Model for Service Delivery for Developmental Disorders in Low-Income Countries. Pediatrics. 2015 Dec;136(6):1166-72. doi: 10.1542/peds.2015-0861.
- Hamdani SU, Atif N, Tariq M, Minhas FA, Iqbal Z, Rahman A. Family networks to improve outcomes in children with intellectual and developmental disorders: a qualitative study. Int J Ment Health Syst. 2014 Feb 1;8(1):7. doi: 10.1186/1752-4458-8-7.
- Hamdani SU, Huma ZE, Wissow L, Rahman A, Gladstone M. Measuring functional disability in children with developmental disorders in low-resource settings: validation of Developmental Disorders-Children Disability Assessment Schedule (DD-CDAS) in rural Pakistan. Glob Ment Health (Camb). 2020 Jul 13;7:e17. doi: 10.1017/gmh.2020.10. eCollection 2020. Erratum In: Glob Ment Health (Camb). 2020 Aug 03;7:e20.
- Hamdani SU, Akhtar P, Zill-E-Huma, Nazir H, Minhas FA, Sikander S, Wang D, Servilli C, Rahman A. WHO Parents Skills Training (PST) programme for children with developmental disorders and delays delivered by Family Volunteers in rural Pakistan: study protocol for effectiveness implementation hybrid cluster randomized controlled trial. Glob Ment Health (Camb). 2017 Jun 13;4:e11. doi: 10.1017/gmh.2017.7. eCollection 2017.
- Hamdani SU, Huma ZE, Suleman N, Akhtar P, Nazir H, Masood A, Tariq M, Koukab A, Salomone E, Pacione L, Brown F, Shire S, Sikander S, Servili C, Wang D, Minhas FA, Rahman A. Effectiveness of a technology-assisted, family volunteers delivered, brief, multicomponent parents' skills training intervention for children with developmental disorders in rural Pakistan: a cluster randomized controlled trial. Int J Ment Health Syst. 2021 May 31;15(1):53. doi: 10.1186/s13033-021-00476-w.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
April 1, 2018
Study Registration Dates
First Submitted
June 1, 2016
First Submitted That Met QC Criteria
June 3, 2016
First Posted (Estimate)
June 8, 2016
Study Record Updates
Last Update Posted (Actual)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 25, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 746-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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