Autism Spectrum DisorderNCT07863752
Mindfulness-Based Intervention for Parents of Autistic Children in Pakistan
A study testing Stronger Together Mindfulness-Based Intervention and Psychoeducation Program in people with Autism Spectrum Disorder and Parental Stress, run by Northeast Normal University at 1 site in Pakistan.
Trial summary
This randomized controlled trial evaluated a culturally adapted mindfulness-based intervention for Pakistani parents of children with autism spectrum disorder. Sixty-eight parents were randomly assigned to one of three groups: a mindfulness-based intervention (n = 23), an active psychoeducation comparator (n = 23), or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder, Parental Stress
- What is being tested?
- Stronger Together Mindfulness-Based Intervention and Psychoeducation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2026to 5 Aug 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants were eligible if they were: (1) a primary caregiver (mother or father) of a child with a clinician-confirmed DSM-5 diagnosis of autism spectrum disorder; (2) aged 18 years or older; (3) residing in or able to access the intervention center in Bahawalpur; (4) able to attend all eight weekly group sessions; and (5) able to communicate in spoken or written Urdu or English.
Who cannot join
- Participants were excluded if they were: (1) receiving individual psychotherapy or another structured group psychological intervention at the same time; (2) had an active severe psychiatric diagnosis, such as psychosis or suicidality; or (3) their child was not living in the family home or was in residential care.
- -
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Alfalah Autism and rehabilitation Center.
Chak Eighty-seven -Twelve Left, Punjab Province, 63100
About this study
Official title: Effectiveness of a Mindfulness-Based Intervention for Parents of Autistic Children in Pakistan: A Randomized Controlled Trial
This randomized controlled trial evaluated a culturally adapted mindfulness-based intervention for Pakistani parents of children with autism spectrum disorder. Sixty-eight parents were randomly assigned to one of three groups: a mindfulness-based intervention (n = 23), an active psychoeducation comparator (n = 23), or a waitlist control (n = 22). The mindfulness-based intervention and psychoeducation programs were delivered in eight weekly group sessions. Participants completed assessments at baseline, immediately after the intervention, and one month after the intervention. The study examined changes in mindfulness, self-compassion, and parenting stress among parents of children with autism spectrum disorder.
Read the detailed description
This study evaluated a culturally adapted mindfulness-based intervention for parents of children with autism spectrum disorder (ASD) in Pakistan using a three-arm randomized controlled trial design. Participants were randomly allocated to a mindfulness-based intervention (Stronger Together), an active psychoeducation comparator, or a waitlist control condition.
Participants were primary caregivers (mothers or fathers) of children with a clinician-confirmed DSM-5 diagnosis of ASD. Eligible participants were aged 18 years or older, resided in or could access the intervention center in Bahawalpur, were able to attend the eight weekly group sessions, and were able to communicate in spoken or written Urdu or English. Participants were excluded if they were receiving individual psychotherapy or another structured group psychological intervention at the same time, had an active severe psychiatric diagnosis such as psychosis or suicidality, or if their child was not living in the family home or was in residential care. Written informed consent was obtained before baseline assessment.
A total of 68 participants were randomly allocated to the mindfulness-based intervention (n = 23), psychoeducation comparator (n = 23), or waitlist control (n = 22). Randomization was conducted using a computer-generated random number sequence prepared by an independent researcher who was not involved in data collection. Allocation was concealed using sequentially numbered, opaque sealed envelopes. Participants could not be blinded to group assignment because the study involved group-based interventions. The research assistant who administered and scored the outcome questionnaires was blinded to group allocation, and the statistician received anonymized group labels for the primary analyses.
The mindfulness-based intervention and psychoeducation comparator were delivered in groups of approximately 6-8 participants over eight weekly sessions, with each session lasting approximately 2 hours and 10 minutes. The two conditions were delivered separately by trained personnel without cross-group contact. Both programs used bilingual Urdu/English materials. The mindfulness-based intervention was culturally adapted for the Pakistani context and incorporated culturally relevant examples, Urdu terminology, and Islamic references.
Assessments were conducted at three time points: baseline (T1), immediately after the intervention (T2), and one-month follow-up (T3). The study assessed parenting stress, affiliate stigma, cognitive emotion regulation, mindfulness, self-compassion, Islamic religious coping, and psychological distress using standardized questionnaires.
- Conditions
- Autism Spectrum Disorder, Parental Stress
- Being tested
- Stronger Together Mindfulness-Based Intervention, Psychoeducation Program
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stronger Together Mindfulness-Based InterventionBehavioural
A culturally adapted group mindfulness-based intervention consisting of 8 weekly sessions of approximately 2 hours and 10 minutes each. The program incorporated mindfulness practices, stress awareness, emotion regulation, cognitive defusion, self-compassion, social support, values clarification, and maintenance planning. The intervention was delivered in Urdu/English using standardized materials, with culturally relevant examples and Islamic references. Weekly home practice was reinforced through reminders.
Psychoeducation ProgramBehavioural
A structured group psychoeducation program delivered over 8 weekly sessions of approximately 2 hours and 10 minutes each. The program was delivered separately from the mindfulness-based intervention by trained personnel using standardized bilingual Urdu/English materials.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Intervention | Experimental | Participants received the Stronger Together culturally adapted mindfulness-based intervention in a group format. The intervention consisted of 8 weekly sessions, with each session lasting approximately 2 hours and 10 minutes. Sessions addressed mindfulness, stress awareness, emotion regulation, cognitive defusion, stigma and self-compassion, social support, values, and maintenance of skills. The intervention was delivered using standardized Urdu/English materials and included culturally relevant examples and Islamic references. Receives: Behavioral: Stronger Together Mindfulness-Based Intervention; Behavioral: Psychoeducation Program |
| Psychoeducation | Active comparator | Participants received a structured psychoeducation program delivered in a group format over 8 weekly sessions. The psychoeducation condition served as an active comparator and was delivered separately from the mindfulness-based intervention by trained personnel using standardized bilingual Urdu/English materials. Receives: Behavioral: Stronger Together Mindfulness-Based Intervention; Behavioral: Psychoeducation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Stress
Parenting stress was assessed using the Parenting Stress Scale (PSS) to measure perceived stress associated with the parenting role among parents of children with autism spectrum disorder.
Measured: Baseline (T1), immediately post-intervention (T2), and one-month follow-up (T3)
Affiliate Stigma
Affiliate stigma was assessed using the Affiliate Stigma Scale (ASS) to measure stigma-related internalized feelings and attitudes among parents of children with autism spectrum disorder.
Measured: Baseline (T1), immediately post-intervention (T2), and one-month follow-up (T3)
Secondary outcomes (4)
Adaptive Cognitive Emotion Regulation
Adaptive cognitive emotion regulation was assessed using the adaptive subscale of the Cognitive Emotion Regulation Questionnaire (CERQ).
Measured: Baseline (T1), immediately post-intervention (T2), and one-month follow-up (T3)
Maladaptive Cognitive Emotion Regulation
Maladaptive cognitive emotion regulation was assessed using the maladaptive subscale of the Cognitive Emotion Regulation Questionnaire (CERQ).
Measured: Baseline (T1), immediately post-intervention (T2), and one-month follow-up (T3)
Islamic Religious Coping
Islamic religious coping was assessed using the Islamic Religious Coping Scale (IRCS).
Measured: Baseline (T1), immediately post-intervention (T2), and one-month follow-up (T3)
Psychological Distress
Psychological distress was assessed using the Depression Anxiety Stress Scale (DASS).
Measured: Baseline (T1), immediately post-intervention (T2), and one-month follow-up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 May 2026
- Primary completion5 Aug 2026
- Study completion5 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeast Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shagufta Batool, Northeast Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863752
- Sponsor's protocol ID
- STRONGTOGETHER-01
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because the study data contain potentially sensitive participant information. Only aggregated, de-identified results will be reported in publications and other research outputs.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mindfulness-Based Intervention for Parents of Autistic Children in Pakistan: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07863752
- Acronym / sponsor ID
- STRONGTOGETHER-01
- Conditions
- Autism Spectrum Disorder, Parental Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Northeast Normal UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 5 Aug 2026 (actual)
- Study completion
- 5 Aug 2026 (actual)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial evaluated a culturally adapted mindfulness-based intervention for Pakistani parents of children with autism spectrum disorder. Sixty-eight parents were randomly assigned to one of three groups: a mindfulness-based intervention (n = 23), an active psychoeducation comparator (n = 23), or a waitlist control (n = 22). The mindfulness-based intervention and psychoeducation programs were delivered in eight weekly group sessions. Participants completed assessments at baseline, immediately after the intervention, and one month after the intervention. The study examined changes in mindfulness, self-compassion, and parenting stress among parents of children with autism spectrum disorder.
Detailed description
This study evaluated a culturally adapted mindfulness-based intervention for parents of children with autism spectrum disorder (ASD) in Pakistan using a three-arm randomized controlled trial design. Participants were randomly allocated to a mindfulness-based intervention (Stronger Together), an active psychoeducation comparator, or a waitlist control condition.
Participants were primary caregivers (mothers or fathers) of children with a clinician-confirmed DSM-5 diagnosis of ASD. Eligible participants were aged 18 years or older, resided in or could access the intervention center in Bahawalpur, were able to attend the eight weekly group sessions, and were able to communicate in spoken or written Urdu or English. Participants were excluded if they were receiving individual psychotherapy or another structured group psychological intervention at the same time, had an active severe psychiatric diagnosis such as psychosis or suicidality, or if their child was not living in the family home or was in residential care. Written informed consent was obtained before baseline assessment.
A total of 68 participants were randomly allocated to the mindfulness-based intervention (n = 23), psychoeducation comparator (n = 23), or waitlist control (n = 22). Randomization was conducted using a computer-generated random number sequence prepared by an independent researcher who was not involved in data collection. Allocation was concealed using sequentially numbered, opaque sealed envelopes. Participants could not be blinded to group assignment because the study involved group-based interventions. The research assistant who administered and scored the outcome questionnaires was blinded to group allocation, and the statistician received anonymized group labels for the primary analyses.
The mindfulness-based intervention and psychoeducation comparator were delivered in groups of approximately 6-8 participants over eight weekly sessions, with each session lasting approximately 2 hours and 10 minutes. The two conditions were delivered separately by trained personnel without cross-group contact. Both programs used bilingual Urdu/English materials. The mindfulness-based intervention was culturally adapted for the Pakistani context and incorporated culturally relevant examples, Urdu terminology, and Islamic references.
Assessments were conducted at three time points: baseline (T1), immediately after the intervention (T2), and one-month follow-up (T3). The study assessed parenting stress, affiliate stigma, cognitive emotion regulation, mindfulness, self-compassion, Islamic religious coping, and psychological distress using standardized questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Intervention | Experimental | Behavioral: Stronger Together Mindfulness-Based Intervention, Behavioral: Psychoeducation ProgramParticipants received the Stronger Together culturally adapted mindfulness-based intervention in a group format. The intervention consisted of 8 weekly sessions, with each session lasting approximately 2 hours and 10 minutes. Sessions addressed mindfulness, stress awareness, emotion regulation, cognitive defusion, stigma and self-compassion, social support, values, and maintenance of skills. The intervention was delivered using standardized Urdu/English materials and included culturally relevant examples and Islamic references. |
| Psychoeducation | Active comparator | Behavioral: Stronger Together Mindfulness-Based Intervention, Behavioral: Psychoeducation ProgramParticipants received a structured psychoeducation program delivered in a group format over 8 weekly sessions. The psychoeducation condition served as an active comparator and was delivered separately from the mindfulness-based intervention by trained personnel using standardized bilingual Urdu/English materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants were eligible if they were: (1) a primary caregiver (mother or father) of a child with a clinician-confirmed DSM-5 diagnosis of autism spectrum disorder; (2) aged 18 years or older; (3) residing in or able to access the intervention center in Bahawalpur; (4) able to attend all eight weekly group sessions; and (5) able to communicate in spoken or written Urdu or English.
Key exclusion criteria (2 listed)
- Participants were excluded if they were: (1) receiving individual psychotherapy or another structured group psychological intervention at the same time; (2) had an active severe psychiatric diagnosis, such as psychosis or suicidality; or (3) their child was not living in the family home or was in residential care.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stronger Together Mindfulness-Based InterventionA culturally adapted group mindfulness-based intervention consisting of 8 weekly sessions of approximately 2 hours and 10 minutes each. The program incorporated mindfulness practices, stress awareness, emotion regulation, cognitive defusion, self-compassion, social support, values clarification, and maintenance planning. The intervention was delivered in Urdu/English using standardized materials, with culturally relevant examples and Islamic references. Weekly home practice was reinforced through reminders. | Behavioural | Mindfulness-Based Intervention, Psychoeducation |
| Psychoeducation ProgramA structured group psychoeducation program delivered over 8 weekly sessions of approximately 2 hours and 10 minutes each. The program was delivered separately from the mindfulness-based intervention by trained personnel using standardized bilingual Urdu/English materials. | Behavioural | Mindfulness-Based Intervention, Psychoeducation |
Primary outcome
Parenting Stress
Time frame: Baseline (T1), immediately post-intervention (T2), and one-month follow-up (T3)
Parenting stress was assessed using the Parenting Stress Scale (PSS) to measure perceived stress associated with the parenting role among parents of children with autism spectrum disorder.
Affiliate Stigma
Time frame: Baseline (T1), immediately post-intervention (T2), and one-month follow-up (T3)
Affiliate stigma was assessed using the Affiliate Stigma Scale (ASS) to measure stigma-related internalized feelings and attitudes among parents of children with autism spectrum disorder.
4 secondary outcomes
Adaptive Cognitive Emotion Regulation
Time frame: Baseline (T1), immediately post-intervention (T2), and one-month follow-up (T3)
Maladaptive Cognitive Emotion Regulation
Time frame: Baseline (T1), immediately post-intervention (T2), and one-month follow-up (T3)
Islamic Religious Coping
Time frame: Baseline (T1), immediately post-intervention (T2), and one-month follow-up (T3)
Psychological Distress
Time frame: Baseline (T1), immediately post-intervention (T2), and one-month follow-up (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because the study data contain potentially sensitive participant information. Only aggregated, de-identified results will be reported in publications and other research outputs.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stronger Together Mindfulness-Based Intervention and Psychoeducation Program in people with Autism Spectrum Disorder and Parental Stress, run by Northeast Normal University at 1 site in Pakistan.
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 1 inclusion and 2 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Parenting Stress (time frame: Baseline (T1), immediately post-intervention (T2), and one-month follow-up (T3)). 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?
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 7 Oct 2026.