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Intellectual Disability, Mild to ModerateBSTNCT06732479

Behavioural Skills Training (BST) for Teaching Sexual Abuse Prevention Skills for Children With Intellectual Disabilities

A study testing Behavioural Skill Training Programme in people with Intellectual Disability, Mild to Moderate and Sexual Abuse, run by University of Canberra.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 18 years
What is being tested?
Behavioural Skill Training Programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
8 Aug 2016to 11 Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
  • Parents (either mother or father) who are willing to participate as co therapists.
  • Parents staying with the child for at least for one year and are the primary care givers of the child. Exclusion criteria
  • Parents who cannot speak Malayalam/ English
  • Parents who are not willing to participate in the one month,3 month and 6 month follow ups.

Who cannot join

  • Children who cannot speak Malayalam/English
  • Presence of active symptoms of co morbid psychiatric illness
  • Parent

About this study

Official title: Effectiveness of Behavioural Skills Training (BST) on Knowledge of Sexual Abuse and Resistance Ability Among Children With Intellectual Disabilities: A Randomized Controlled Trial

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.

Read the detailed description

Sexual abuse of children with intellectual disabilities is a global concern. Rate of sexual abuse among children with intellectual disabilities is 2-4 times the rate in general population. Thirty-nine to 83% of girls and 16%- 32% of boys with Intellectual Disability typically experience sexual abuse by the time they reach the age of 18. There is a need for personal safety programs as one of the multiple approaches to reduce the risk of child sexual abuse. In order to protect themselves against abuse, children with intellectual disability must have the skills to independently recognise potentially abusive situations and respond appropriately. Even though some of the abuse prevention programmes are widely used, the effectiveness of these is not established. The aim of the study was to assess the effectiveness of a Behavioural Skills Training on knowledge of sexual abuse and resistance ability among children with Intellectual Disability.

Sample size calculation for this study was conducted using power analysis, based on the variance from the pilot study. Considering a statistical power of 80% and a significance level set at 5%, 134 children were initially recruited for the study. However, upon concluding the six months, data was available to only 120 subjects. Among these, 60 children received the intervention ( experimental group), while the remaining 60 received Treatment as Usual (the control group).

This study developed a Video based Behavioural Skill Training programme for training children with intellectual disabilities for improving their knowledge regarding sexual abuse and resistance ability against sexual abuse and tested its effectiveness. The study involved children initially watching video presentations depicting appropriate and inappropriate situations and the ideal responses for each scenario. Subsequently, the children engaged in role-playing exercises, where a researcher assumed the roles of a perpetrator, doctor, or nurse. At the same time, parents who participated as co-therapists in the study played their parents' part in the role play. Following each enactment of inappropriate situations, the children were instructed to approach their parents and report the individual's identity and the incident. This role-playing process was reiterated until the children had comprehensively learned the appropriate responses.

The effectiveness of the study was evaluated based on the change in the knowledge scores and resistance ability scores. A randomized controlled design with longitudinal measurement of outcomes was adopted to evaluate the effectiveness of BST on Knowledge of Sexual Abuse and Resistance Ability. Screening for all the children was done in each selected special schools based on the inclusion and exclusion criteria. All subjects who met the criteria were selected for the study.

The children and parents involved in the study were clearly informed about its purpose and objectives. Written informed consent was obtained from the parents, and an attempt was made to obtain assent from the children. Forty-two percent of the children were able to provide signed assent. Participants were assured that the information they provided would remain confidential. It was also ensured that the BST would not interfere with the children's regular school schedules. The investigator closely monitored the children and their parents during the intervention to address any potential adverse effects.

At the outset of our research project, we initiated meetings with parents and children to establish mutual understanding and rapport. The teachers played a crucial role in interactions with the parents and children. They helped establish contact with the parents and took on the role of introducing us to both the parents and the children. Their support and involvement were instrumental in creating a welcoming and cooperative atmosphere for our research endeavours. During these meetings, we encouraged parents and children to ask any questions they had about the research. This open and transparent dialogue was a valuable foundation for collaborative efforts and ensured that all parties involved were well-informed and comfortable with the research process.

The introduction to the children was facilitated by the class teacher, allowing us to interact with them within the classroom setting before conducting interviews. This preliminary interaction reduced any sense of unfamiliarity or apprehension among the children. Prior to commencing the interviews, we obtained assent from each child. We informed them that we would ask questions about personal safety and protecting themselves in various situations.

Each child was individually interviewed in an open classroom or library, ensuring a comfortable and non-intimidating environment. The administration sequence first involved conducting the Personal Safety Questionnaire (PSQ) and the video-enhanced 'What If Situation Test' (WIST). Both assessments were administered orally, with responses recorded on paper-based tools. The sessions were conducted in small groups, typically consisting of children, within classroom settings, library halls, or auditoriums. It is essential to note that the child's parents also actively participated in these training sessions and were encouraged to reinforce the training at home. Each training session had a duration of approximately 1 hour.

To analyse the data, verbatim interview responses were coded, with scores assigned for each question or item. This systematic approach allowed for a comprehensive assessment of the children's understanding of personal safety and their ability to respond effectively to various situations.

After the study's completion, the BST was also provided to the control group. Subjects in the experimental and control group was assessed for their knowledge and resistance ability before the intervention and post assessment was done after the intervention. Descriptive statistics were applied for the baseline data. Descriptive statistics includes frequency distributions, mean and median for the central tendency and range and standard deviation. Chi square was done to find the association between the categorical variables. To assess the effectiveness of the intervention program, Mann Whitney U was done to compare the outcome measures between the experimental and control group All the analysis was performed in IBM SPSS statistics 22 and a p-level of <0.05 was considered as statistically significant. Mean age (in years) of the total sample (n=120) was 15.6 ±2.6 and it was 15.3 ± 2.7 in experimental group (n=60) and 15.9 ± 2.5 in control group (n=60). In the sample 59.2% of the children belonged to the category of mild intellectual disabilities and rest were with moderate intellectual disabilities.

The BST was found to be effective in increasing knowledge (P<0.01) regarding sexual abuse and resistance ability (P<0.01) against sexual abuse among children with mild or moderate disabilities.

Being tested
Behavioural Skill Training Programme
Keywords
Behavioural Skills Training, children with intellectual disabilities, Sexual abuse prevention, sexual abuse and resistance ability
Medical subject headings
Intellectual Disability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioural Skill Training ProgrammeBehavioural

    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
Study groups in NCT06732479
Study groupRoleWhat they receive
Control group: Treatment as usual (TAU)No interventionThese 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)ExperimentalThe 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.
Receives: Behavioral: Behavioural Skill Training Programme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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.

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

Secondary outcomes (1)
  1. Side effects measure

    The 12-item fear assessment thermometer scale assessesparticipants' fear of various objects, people and situations. Participants' fear is rated by moving a simulated mercury column from 1 (not at all afraid) to 7 (very much afraid)on a card board representation of a thermometer. Scores ranged from 12 to 84.

    After the pilot study, this scale was modified with the permission of the original author, since the children had difficulty to differentiate seven categories, and hence categories were changed to very much afraid (3), slightly afraid (2), not at all afraid (1). The revised scores range from 12 to 36.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2024
  2. Study start8 Aug 2016
  3. Primary completion11 Mar 2017
  4. Study completion11 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06732479
Sponsor's protocol ID
NIMHANS/DO/101ST IEC/2015
Other IDs
NIMH:A&E/C:Ph.D(Nsg):2014-16:N
Acronym
BST
Status last verified
Dec 2024
First submitted
8 Dec 2024
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This will not be shared to protect the confidentiality and privacy of the participants

Publications

  • 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.

    PubMed 25085114
  • 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.

    PubMed 36603444

Questions about this trial

What is this clinical trial studying?

A study testing Behavioural Skill Training Programme in people with Intellectual Disability, Mild to Moderate and Sexual Abuse, run by University of Canberra.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Personal Safety Questionnaire (time frame: pre intervention and one week, one month, 3 month and 6 months after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06732479, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.

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