NCT06732479

Brief Summary

The main goal of the study was to see if Behavioural Skills Training (BST) could improve knowledge about sexual abuse and the ability to resist it among children with intellectual disabilities. This study also evaluated any negative effects of the programme on children with intellectual disabilities. There were two groups, one group received a training programme which was delivered as three one-hour sessions in a week over 12 weeks. The Behavioral Skills Training (BST) module was structured into ten lessons, each conveyed through engaging stories and corresponding illustrations. The training commenced with teaching children general safety topics such as poison, fire, pedestrian, and vehicle safety. This served as an initial step to establish comfort. Subsequently, the module transitioned to imparting knowledge on body safety rules. This included educating children on stranger safety and private parts, understanding appropriate and inappropriate touches, and teaching them self-protection skills. Videos were used to show appropriate and inappropriate situations effectively, and training sessions involved role-playing scenarios. Another group received the usual sex education offered by teachers at school. After completing training students were assessed for their knowledge regarding sexual abuse and their self-protection skills (ability to say no, remove themselves from the situation, identify a person to whom the incident can be reported and report the incident and identify the offender. This was assessed based on the situations presented in a video. Children were tested one week after the training, at one-month, three-month and six-month intervals to see whether they could retain the information and skill. Their knowledge and self-protection skills improved after attending the programme and it was retained for six months. Participation in the programme did not cause any negative effects among children with intellectual disabilities.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2017

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

December 8, 2024

Last Update Submit

December 12, 2024

Conditions

Keywords

Behavioural Skills Trainingchildren with intellectual disabilitiesSexual abuse preventionsexual abuse and resistance ability

Outcome Measures

Primary Outcomes (2)

  • Personal Safety Questionnaire

    Designed to evaluate knowledge regarding sexual abuse, this questionnaire consists of 11 items related to personal safety. Participants respond with "yes," "no," or "I do not know" to these items, and scores can range from 0 to 11; a higher score indicates a more comprehensive understanding of sexual abuse. The score range spans from 0 to 11, with an average score of 5.5. Personal Safety Questionnaire (PSQ) demonstrates strong test-retest reliability (r = 0.77) and internal consistency (Cronbach's α = 0.78).

    pre intervention and one week, one month, 3 month and 6 months after the intervention

  • Video supplemented 'what if' situation test

    This test assesses the participant's ability to differentiate appropriate from inappropriate sexual advances and their understanding of hypothetical abusive situations. It includes two practice trials and six brief vignettes. Three vignettes describe appropriate requests for touch, while the other three depict inappropriate requests. The 'What If Situation Test' generates three scale scores: 1) Appropriate request recognition (score range: 0-3), 2) Inappropriate request recognition (score range: 0-3), 3) Total score, which measures knowledge of self-protection skills (score range: 0-24). The total score comprises four specific skill scores that represent the participant's verbal reports on their ability to 1) Refuse advances using appropriate, assertive, and persistent verbal responses (say), 2) Remove themselves from the situation (do), 3) Identify a person to whom the incident can be reported (tell) 4) Report the incident and identify the offender.

    pre intervention and one week, one month, 3 month and 6 months after the intervention

Secondary Outcomes (1)

  • Side effects measure

    pre intervention and one week, one month, 3 month and 6 months after the intervention

Study Arms (2)

Control group: Treatment as usual (TAU)

NO INTERVENTION

These included general safety tips, and the detailed instructions taught to children by teachers in special school during academic programme. As part of the curriculum, teachers taught children about safe touch and unsafe touch and instructed children to say "No" to unsafe touches. Teachers mainly focused on inappropriate touches and the main mode of instruction was lecturing.

Behavioral skill Training (BST)

EXPERIMENTAL

The Behavioural Skill Training (BST) was developed by modifying the Body Safety Training programme developed by Dr.Sandy.K.Wurtele.The Module was organized under 10 lessons. Each lesson was taught through stories, and each story had a picture that goes along with it. Children were taught first about the general safety (poison safety, fire safety, pedestrian safety, and vehicle safety) as a way of establishing rapport, and then moved to body safety rules (stranger safety, concept of private parts, appropriate and inappropriate touches, self-protection skills). Appropriate and inappropriate situations were presented using video and training was given to children on how to respond appropriately to each situation using role play. The Module was delivered over a period of one month, three sessions per week.

Behavioral: Behavioural Skill Training Programme

Interventions

BST was administered in 3 sessions in a week on alternate days, each session lasting for an hour. Training was given in small groups consisting of 4-6 members. Parents were involved as co-therapists, and observed the training given by the researcher and practiced it at home with their children. The training was carried out through the following steps: 1. Instruction- Involved teaching the location of private parts, difference between appropriate and inappropriate touch, safe and unsafe secrets, sexuality, self-protection skills (saying NO, move from situation, tell trusted person, report the person and situation. 2. Modelling- researcher, modelled, correct responses, and instructed to act in the unsafe situation using role play. Situations were presented using video. 3. Rehearsal-researcher presented situations using video and instructed to rehearse the skills until able to demonstrate the skill independently

Behavioral skill Training (BST)

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with mild and moderate Intellectual Disability as per Diagnostic and Statistical manual (DSM) V, and as determined by the assessment of qualified educational psychologists prior to the admission to the special schools.
  • Age 10-18 years
  • Those children whose parents are available during the period of study
  • Children with verbal ability which would allow them to participate in the study

You may not qualify if:

  • Children who cannot speak Malayalam/English
  • Presence of active symptoms of co morbid psychiatric illness
  • Parent
  • Parents (either mother or father) who are willing to participate as co therapists.
  • Parents who cannot speak Malayalam/ English
  • Parents who are not willing to participate in the one month,3 month and 6 month follow ups.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Schaafsma D, Kok G, Stoffelen JM, Curfs LM. Identifying effective methods for teaching sex education to individuals with intellectual disabilities: a systematic review. J Sex Res. 2015;52(4):412-32. doi: 10.1080/00224499.2014.919373. Epub 2014 Aug 1.

    PMID: 25085114BACKGROUND
  • Jojo N, Nattala P, Seshadri S, Krishnakumar P, Thomas S. Knowledge of sexual abuse and resistance ability among children with intellectual disability. Child Abuse Negl. 2023 Feb;136:105985. doi: 10.1016/j.chiabu.2022.105985. Epub 2023 Jan 3.

    PMID: 36603444BACKGROUND

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Dr.Natasha Jojo, PhD

    University of Canberra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were systematically selected using a stratified random sampling approach. The schools were first categorised into three strata based on the number of enrolled children: those with more than 100 children, those between 25 and 100 children, and those with fewer than 25 children. Schools were randomly chosen from each stratum. Two schools with more than 100 children were randomly selected, one designated as the experimental group and the other as the control group. Six schools in the 25 to 100 children were randomly chosen and equally divided into experimental and control groups. Similarly, in the stratum of schools with less than 25 children, four schools were randomly selected and equally split into experimental and control groups. It is important to note that all participants who met the predetermined selection criteria within each selected school for specific purposes were invited to participate in the study, ensuring a comprehensive and representative sample.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 8, 2024

First Posted

December 13, 2024

Study Start

August 8, 2016

Primary Completion

March 11, 2017

Study Completion

March 11, 2017

Last Updated

December 17, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

This will not be shared to protect the confidentiality and privacy of the participants